INMB
NASDAQ · Healthcare · Biotechnology · US
Next report
Analyst consensus
- Next report date
- Oct 29, 2026
- EPS estimate
- -$0.15
- Revenue estimate
- $1.9M
Latest reported
- Last report date
- Aug 6, 2026
- EPS actual
- -$0.05
- EPS estimate
- -$0.21
- Revenue actual
- —
- Revenue estimate
- $1.2M
Track record
Trailing twelve quarters
- EPS beats (12Q)
- 7
- EPS misses (12Q)
- 4
- EPS in line (12Q)
- 1
- Avg surprise (4Q)
- +36.9%
- Revenue beats (12Q)
- 1
Q2 FY2026 · Aug 6, 2026
AI summary of management’s prepared remarks and analyst Q&A · For informational purposes only, not investment advice
Management highlights
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Ebstracell (first lead product from the Chordstrom platform for recessive dystrophic epidermolysis bullosa, RDEB): • Secured full regulatory alignment from the UK's MHRA across CMC, non-clinical, and clinical evidence packages, and received approval of the pediatric investigation plan in under 3 months. The MHRA recognized MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefits for RDEB patients, particularly for pain and pruritus (itch). • Completed a key commercial manufacturing milestone: successfully processed the first commercial-ready umbilical cord tissue at the Stevenage Cell and Gene Therapy Catapult facility, and transferred the MSC isolation stage for master cell bank production to the intended commercial manufacturing site. • Expanded the supply agreement with the Anthony Nolan cord blood bank to secure long-term access to qualified umbilical cord tissue, establishing a scalable supply base to support global regulatory filings and future commercial launch. • The Chordstrom platform patent application entered the US national phase after a favorable international written opinion, with potential protection extending to at least 2045. • A new cross-functional scientific advisory board (SAB) of internationally recognized experts was established to support Ebstracell's late-stage development and prioritize new disease indications for the Chordstrom platform.
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EXPRO (second platform for early Alzheimer's disease): • The FDA granted Fast Track designation for EXPRO in early Alzheimer's disease. • The Phase 2 MINDFUL study achieved a statistically significant treatment effect on white matter myelin MRI biomarkers in the full modified intent-to-treat population (p=0.0028, Cohen's effect size 0.46; effect size increased to 0.59 in the biomarker-enriched population). Expanded analyses presented at AAIC confirmed concordant treatment effects across multiple independent brain structure measures, with no amyloid-related imaging abnormalities observed. • The company completed end-of-Phase 2 alignment with the FDA, and the MINDFUL results were published in peer-reviewed journal NPJ Dementia, strengthening the foundation for the Phase 2b/3 program. Early data from traumatic brain injury and oncology indications supports broader platform optionality, with Alzheimer's disease remaining the clinical priority.
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Financial and operational progress: • A net loss of $1.3 million was recorded for Q2 2026, with a lower burn rate supported by non-dilutive R&D rebate revenue. Cash on hand plus post-quarter rebate proceeds are sufficient to fund operations into Q2 2027.
Guidance
- Ebstracell regulatory submission timeline: MAA for conditional marketing authorization in RDEB will be submitted to the UK MHRA by the end of Q3 2026 or early Q4 2026; MAA submission to the EMA is planned for early 2027, and BLA for conditional approval to the US FDA is planned for Q1 2027. • The open-label Phase 3 confirmatory/safety trial for Ebstracell (the same trial previously guided to) is expected to enroll 40-45 patients (33 already enrolled, mostly from the original Phase 2 trial), with enrollment of 1-2 patients per week, and trial completion and data readout expected mid-2028. • UK approval for Ebstracell is expected in Q2 2027, with commercial launch expected to reach ~100 patients within two years of approval. • Expected quarterly cash burn is $1 million to $1.5 million per month going forward, with existing cash sufficient to fund operations into Q2 2027. • The company confirms its core priority is disciplined execution of Ebstracell regulatory submissions, capital preservation, and advancing the EXPRO program while evaluating strategic partnership opportunities to accelerate development.
Segment performance
InMuneBio is a clinical-stage biotech with two late-stage development product platforms, and has not yet launched any commercial products, so no segment revenue is generated. For the second quarter ended June 30, 2026: net loss attributable to common stockholders was $1.3 million, compared to a $24.5 million net loss in Q2 2025 (the 2025 period included a $16.5 million impairment charge for acquired in-process R&D intangibles). Research and development (R&D) recorded a $0.8 million benefit in Q2 2026, versus a $5.8 million R&D expense in Q2 2025, driven by recognition of additional Australian research and development rebates. General and administrative expenses were flat at $2.3 million in both Q2 2026 and Q2 2025. As of June 30, 2026, the company held $18.4 million in cash and cash equivalents, and received an additional $4.2 million in non-dilutive Australian R&D tax rebates after quarter-end.
Risks & headwinds
- Forward-looking statements (including regulatory timelines, approval expectations, trial results, and cash sufficiency) are subject to inherent risks and uncertainties that could cause actual outcomes to differ materially from projections, including regulatory non-approval, unexpected trial delays, and higher than expected operating costs. • The company relies on external manufacturing and supply chain partners for commercial production of Ebstracell, with operational execution risk associated with scaling manufacturing to support commercial launch. • The company requires additional capital to fund operations beyond Q2 2027, and capital raising may result in shareholder dilution, though management intends to pursue dilutive fundraising only in small, prudent increments. • Pricing and reimbursement approval for Ebstracell in the UK and other markets is dependent on external regulatory negotiations, with final pricing outcomes uncertain.
Analyst Q&A
Q: Is the planned open-label Phase 3 trial for Ebstracell the same 12-month safety trial discussed previously, or is it a new study? What are its key details? / A: It is the same trial previously discussed, and it serves as both the confirmatory Phase 3 and safety trial required for conditional approval. The trial will enroll 40 to 45 total patients, 33 of which are already lined up (almost all are original trial patients who wish to continue treatment), with enrollment of 1 to 2 patients per week. The trial will run for 18 months total, with data readout expected around mid-2028.
Q: What are the biggest regulatory hurdles for Ebstracell approval in the UK/EU, and how have they been addressed? / A: The primary patient- and regulator-recognized endpoints for RDEB are pain and pruritus (itch), which are clinically meaningful: itch directly contributes to wound development and impaired wound healing, a major morbidity for RDEB patients. Management confirms MHRA has already formally aligned on the clinical trial package that demonstrates significant improvements in these endpoints, with additional wound benefit observed at the 6-month mark of the trial, so the regulatory path is very clearly defined.
Q: Can you clarify the company's near-term focus, and provide details on expected pricing and reimbursement for Ebstracell in the UK? / A: The company's primary near-term focus is advancing the Chordstrom platform and Ebstracell regulatory submission and approval. The RDEB patient population is ~800 total in the UK, ~2,000-3,000 in the US, and a similar size in the EU, with ~60% of patients being children. Management expects pricing will be ~400,000 to 500,000 British pounds per patient per year, aligned with expected US pricing, and pricing negotiations will start immediately after MAA submission.
Q: How do you respond to investor views that the company is undervalued, and what is your capital markets strategy? / A: Management agrees the company is currently undervalued, and that execution to achieve Ebstracell approval is required to unlock this value. The rare pediatric disease designation for Ebstracell includes a priority review voucher (PRV) that can be sold for $100 million to $200 million, a value greater than InMuneBio's current market capitalization. Management (as major founding shareholders) is highly dilution-averse, will maintain a low $1-1.5 million monthly burn rate, and will pursue only small, judicious capital raises as needed using the company's existing at-the-market offering facility.
Reported results against consensus at the time of each report · Surprise is computed from the estimate on record · Data as of Oct 29, 2026