Did INmune Bio beat or miss consensus estimates last quarter?

What is the revenue and EPS growth rate for INmune Bio year over year?

What is the market's earnings forecast for INmune Bio next quarter?

What is INmune Bio's latest dividend and current dividend yield?

What were the key takeaways from INmune Bio's earnings call?

What guidance did INmune Bio's management provide for the next earnings period?

What were the key takeaways from INmune Bio’s earnings call?

What factors drove the changes in INmune Bio's revenue and profit?

- **CORDStrom Regulatory Momentum**: U.K. MAA filing on track for Q2 2026; independent trial analysis shows consistent efficacy in reducing systemic inflammation and itch in RDEB. 
- **XPro Alzheimer's Progress**: Phase II data demonstrates cognitive and biomarker improvements in high-inflammation patients; FDA end-of-Phase II meeting in Q1 2026. 
- **Financial Stability**: $27.7M cash runway supports 2026 milestones; R&D expenses down 52% YoY. 
- **Strategic Differentiation**: CORDStrom's systemic anti-inflammatory mechanism and cost-effective manufacturing position it as a leader in rare disease cell therapy.

**【CEO Summary Section】**
- INmune Bio is transitioning post-Alzheimer's trial to focus on advancing CORDStrom for RDEB and XPro for Alzheimer's. 
- CORDStrom Phase II trial in RDEB showed significant reduction in systemic itch, improving quality of life for patients. 
- XPro Phase II trial data indicates efficacy in patients with high baseline inflammation, with plans for end-of-Phase II FDA meeting in Q1 2026. 
- Financial runway extends into Q4 2026, supporting near-term milestones.

**【CFO Financial Commentary】**
- Q3 2025 net loss: $6.5M (vs. $12.1M in 2024). 
- R&D expenses: $4.9M (vs. $10.1M in 2024), driven by reduced clinical trial activity. 
- Cash balance: $27.7M, sufficient for operations into Q4 2026.

**【CORDStrom Program Update】**
- CORDStrom manufacturing transfer complete; U.K. MAA filing expected Q2 2026, U.S. BLA submission to follow. 
- Independent statistical analysis of RDEB trial data shows consistent improvement in disease activity scores across all patient subgroups. 
- CORDStrom's cytokine-activated mechanism provides systemic anti-inflammatory effects, differentiating it from topical gene therapies.

**【XPro Program Update】**
- Peer-reviewed manuscript published detailing Phase II MINDFuL trial results, showing longer treatment durations correlate with greater cognitive and biomarker improvements. 
- Regulatory alignment with FDA on accelerated approval pathway expected in Q1 2026. 
- MRI data analysis underway to validate neuroimaging endpoints (white matter integrity, gray matter preservation).

**【Q&A Highlights】**
- **Regulatory Pathway**: FDA feedback on XPro's accelerated approval pathway expected Q1 2026; MHRA scientific advice meeting scheduled for early 2026. 
- **Partnerships**: Early-stage discussions for XPro and INKmune; CORDStrom expected to be commercialized internally due to cost-effectiveness. 
- **Market Potential**: CORDStrom pricing below gene therapy competitors, with U.K. NHS support for reimbursement. 
- **Manufacturing Advantage**: CORDStrom's pooled donor MSC platform enables scalable, cost-efficient production with batch consistency.

INmune Bio, Inc. (INMB) Q3 2025 Earnings Call Transcript

- **XPro Breakthrough**: Alzheimer's drug shows 0.27 effect size in high-inflammation subgroup, with no safety issues. Seeking partnerships to advance Phase III.
- **CORDStrom Milestone**: U.S. and U.K. submissions by mid-2026, targeting expanded indications with customizable MSC therapy.
- **Financial Caution**: $24.5M Q2 loss, $16.5M asset write-off, but $33.4M cash runway to Q3 2026.
- **INKmune Safety**: NK cell activation confirmed, but no disease impact in late-stage prostate cancer; shifting focus to earlier-stage trials.

**【CEO Summary Section】**
- **XPro Phase II Results**: Alzheimer's drug showed no primary endpoint in overall population but significant benefits in subgroup with high inflammation (≥2 biomarkers). Effect sizes (0.27 on EMACC, 0.23 on NPI) comparable to approved therapies. Safety profile with no ARIA despite high-risk patients.
- **Strategic Pause for XPro**: Halted further AD development to seek partnerships, writing off $16.5M intangible asset due to Phase III cost uncertainty.
- **CORDStrom Progress**: On track for U.S. BLA and U.K. MAA submissions by mid-2026. Exploring expanded indications beyond RDEB, including osteoarthritis, with tailored MSC formulations.
- **INKmune Update**: Phase I/II trial met safety endpoints, showing NK cell activation but no disease impact in advanced prostate cancer. Planning trials for earlier-stage patients.
- **Financial Overview**: Q2 2025 net loss of $24.5M (vs. $9.7M in 2024), R&D expenses $5.8M, cash of $33.4M to fund into Q3 2026.

**【XPro Data Details】**
- **Subgroup Analysis**: 40%-60% of AD patients with high inflammation could benefit. Placebo group stability highlighted need for enriched biomarker criteria.
- **Mechanism Validation**: P-Tau 217 and GFAP trends support neurodegenerative impact. Behavioral benefits (NPI) align with caregiver priorities.
- **FDA Engagement**: Preparing for Q4 end-of-Phase II meeting and breakthrough therapy designation application.

**【CORDStrom and INKmune Updates】**
- **CORDStrom Manufacturing**: Umbilical cord-derived MSCs offer stability and customization for different indications. Gene-modified variants (e.g., collagen VII) under evaluation.
- **INKmune Commercialization**: Least expensive cellular oncology drug with day clinic administration. Phase II data show efficacy in NK-deficient patients.

**【Q&A Highlights】**
- **FDA Meeting Timeline**: Briefing book submission expected in Q4, with meeting likely in November/December 2025.
- **Partnership Strategy**: Seeking partners for Phase III funding, with potential announcements in H1 2026. Focus on neuroinflammation differentiation.
- **Biomarker Validation**: EMACC endpoint gaining industry support, with 4 companies now using it. NPI's behavioral impact validation ongoing.
- **CORDStrom Statistical Review**: Independent analysis expected to refine crossover trial data, with open-label extension planned post-BLA submission.

INmune Bio, Inc. (INMB) Q2 2025 Earnings Call Transcript

- **Alzheimer’s Breakthrough Potential**: 70%+ early AD patients eligible for XPro; no safety issues in elderly trial population. June data could redefine Alzheimer’s treatment paradigm.
- **Exclusive Market Position**: XPro targets 15% of AD patients excluded from EU/UK anti-amyloid drugs. U.S. adoption could accelerate post-approval.
- **Robust Pipeline Execution**: CORDstrom BLA on track for 2026; INKmune prostate cancer trial near completion. Manufacturing infrastructure ready for commercial scale.
- **Financial Sustainability**: $19.3M cash runway through Q3 2025. Cost controls reduce R&D expenses by 13% YoY.


**【CEO Summary Section】**
- **MINDFuL Trial Update**: Phase 2 Alzheimer’s trial topline results expected mid-June. Over 70% of early AD patients may qualify for XPro based on ApoE4 status, up from 40%. XPro shows no safety issues in elderly patients with comorbidities.
- **Market Opportunity**: XPro uniquely targets ApoE4 homozygotes excluded from anti-amyloid drugs in EU/UK. U.S. practice patterns suggest unmet need for XPro in this subgroup.
- **Biomarker Insights**: XPro reduced p-tau217 in Phase 1; this biomarker is now central to Alzheimer’s research and may serve as a pharmacodynamic marker.
- **Pipeline Progress**: CORDstrom BLA filing for RDEB in 2026; INKmune prostate cancer trial on track for 2025 enrollment completion.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Net loss of $9.7M (down 12% YoY). R&D expenses $7.6M (down 13% YoY). Cash of $19.3M as of March 31, sufficient for operations through Q3 2025.
- **Milestones**: XPro Phase 2 readout in June; Phase 3 design meeting with FDA in Q4 2025. CORDstrom BLA submission in H1 2026. Phase 2 depression trial contingent on NIH funding.

**【Q&A Highlights】**
- **FDA Dynamics**: FDA remains focused on drug development despite internal turnover. EMAC (Evaluating Memory and Cognition) validation process progressing as planned.
- **Trial Design**: Phase 3 trial size and endpoints will depend on Phase 2 data and FDA feedback. Current trial design includes biomarkers like p-tau217 and CDR-SB.
- **Competitive Landscape**: Abeona’s gene therapy for RDEB highlights unmet need for systemic treatments. CORDstrom’s systemic approach differentiates it from localized therapies.
- **Manufacturing**: Transitioning to U.S.-based manufacturing for INKmune and CORDstrom to meet regulatory requirements and scale production.


INmune Bio, Inc. (INMB) Q1 2025 Earnings Call Transcript

- **Alzheimer's Breakthrough Imminent**: Phase 2 trial with XPro targeting neuroinflammation in early AD set to report June 2025. Unique biomarker-driven patient selection and novel cognitive test (EMACC) differentiate from amyloid-centric approaches.
- **RDEB Therapy on Fast Track**: CORDStrom BLA filing planned for Q1 2026, with open-label trial underway. Potential first commercial product addressing systemic inflammation in RDEB.
- **Financial Resilience**: $20.9M cash on hand, with warrant acceleration offering $30M upside if ADO2 succeeds. Management prioritizes cost efficiency amid biotech volatility.

**【CEO Clinical Program Update】**
- **ADO2 Alzheimer's Trial**: Phase 2 trial with XPro targeting neuroinflammation in early AD patients is nearing completion. Top-line data expected in June 2025, with 208 patients enrolled across 8 countries. Trial uniquely selects patients based on peripheral inflammation biomarkers (e.g., CRP), differing from amyloid-focused approaches. Primary endpoint uses EMACC, a novel cognitive test designed for early AD. Safety profile robust with no serious adverse events.
- **CordStrom for RDEB**: BLA filing for CORDStrom, an allogeneic cord-derived mesenchymal stem cell therapy, planned for Q1 2026. Trial data shows systemic reduction of inflammation and wound healing in children with recessive dystrophic epidermolysis bullosa (RDEB). Open-label extension trial underway in the UK, with U.S. IND preparation in progress.
- **INmune Solid Tumor Program**: Phase 1/2 trial for metastatic castration-resistant prostate cancer (mCRPC) progressing, with medium and high dose cohorts enrolling. BLA submission for CordStrom expected in Q1 2026, positioning INmune Bio for potential commercialization.

**【CFO Financial Overview】**
- **2024 Financials**: Net loss of $42.1M (vs. $30M in 2023) driven by R&D expenses ($33.2M vs. $20.3M). Cash reserves of $20.9M at year-end, with $5.4M raised post-year-end via ATM. Warrant acceleration tied to ADO2 success could yield up to $30M in additional capital.
- **Upcoming Milestones**: ADO2 data release in June, Phase 2 mCRPC trial completion by end-2025, and CordStrom BLA filing in Q1 2026. Management emphasizes cost discipline and alignment with shareholders.

**【Q&A Highlights】**
- **Regulatory Path for CordStrom**: FDA review of existing clinical data supports BLA eligibility. MHRA feedback expected early 2026. Open-label trial will assess long-term efficacy and dosing regimen.
- **ADO2 Data Release**: Both EMACC and CDR endpoints will be disclosed simultaneously in June. Trial design ensures statistical power despite 72% screen failure rate, with <10% attrition due to inflammation biomarkers.
- **Commercial Strategy**: No definitive partner identified, but potential interest in XPro and CordStrom post-positive data. Focus on regulatory approvals before exploring partnerships.

Actual			-0.19	-0.2	-0.36	-0.26	-0.32	-0.44	-0.55	-0.57	-0.39	-0.38	-0.43	-0.32	-0.36	-0.36	-0.48	-0.47	-0.61	-0.5	-0.6	-0.4	-0.43	-1.05	-0.24
Forecast			-0.21	-0.23	-0.1725	-0.3075	-0.2724	-0.34	-0.3627	-0.5755	-0.5661	-0.4863	-0.525	-0.485	-0.02	-0.3965	-0.3933	-0.4267	-0.535	-0.63	-0.5067	-0.5479	-0.4709	-0.384	-0.318	-0.26
Surprise	0.00%	0.00%	+9.52%	+13.04%	-108.70%	+15.45%	-17.47%	-29.41%	-51.64%	+0.96%	+31.11%	+21.86%	+18.10%	+34.02%	-1700.00%	+9.21%	-22.04%	-10.15%	-14.02%	+20.63%	-18.41%	+26.99%	+8.69%	-173.44%	+24.53%	0.00%

Actual	--	--	0	0	0	0	4.00K	0	14.00K	183.50K	163.00K	16.00K	98.00K	94.00K	38.00K	46.00K	43.00K	25.00K	14.00K	0	0	0	50.00K	0	0	--
Forecast	--	--	0	0	0	0	0	0	1.45M	0	0	0	0	0	--	38.00K	46.00K	43.00K	28.00K	14.00K	333	0	0	0	0	0
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-99.03%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+21.05%	-6.52%	-41.86%	-50.00%	-100.00%	-100.00%	0.00%	0.00%	0.00%	0.00%	0.00%

INMB

INMB fundamentals

INMB Q4 2025 Earnings Preview

Earnings Call

You can ask Aime

INMB

INMB fundamentals

INMB Q4 2025 Earnings Preview

Earnings Call

INMB Earnings Call Summary for Q4/2025Upcoming4:30 PM on Mar 30, 2026

INMB Earnings Call Summary for Q3/20254:30 PM on Oct 30, 2025

INMB Earnings Call Summary for Q2/20254:30 PM on Aug 7, 2025

INMB Earnings Call Summary for Q1/20254:30 PM on May 8, 2025

INMB Earnings Call Summary for Q4/20244:30 PM on Mar 27, 2025

You can ask Aime