INmune Bio's Earnings Call: Trial Scope and Regulatory Timelines Clash with Earlier Guidance

Date of Call: Aug 6, 2026

Guidance:

• Submit Ebstracell UK MAA by end of Q3 or early Q4 2026.
• Submit EMA MAA in early 2027 and BLA to FDA in Q1 2027.
• Cash resources sufficient to fund operations into Q2 2027.
• Expect burn rate of $1M-$1.5M per month (excluding one-time R&D rebates).
• Plan to raise capital judiciously through end of 2027.

Business Commentary:

Regulatory and Manufacturing Progress for Ebstracell:

• ImmuneBio secured formal MHRA alignment, received approval for a pediatric investigation plan, completed a commercial manufacturing milestone, and strengthened its supply chain.
• These achievements reduced regulatory and operational risks, enabling the planned submission of a marketing authorization application (MAA) to the MHRA by the end of Q3 or early Q4 2026.
• The progress was driven by strategic execution in aligning with regulatory requirements and establishing a scalable supply foundation.

Clinical and Regulatory Milestones for Expro:

• Expro received FDA fast-track designation for early Alzheimer's disease, and its Phase 2 mindful study showed a statistically significant treatment effect on white matter myelin MRI biomarkers.
• The treatment difference was P.0028 with a Cohen's effect size of 0.46, and the effect size increased to 0.59 in the biomarker-enriched population.
• The FDA's end-of-phase-2 alignment and publication of results in NPJ dementia strengthened the clinical and regulatory foundation for the Phase 2b3 program.

Financial Performance and Cash Position:

• ImmuneBio reported a net loss of $1.3 million for Q2 2026, compared to a net loss of $24.5 million for Q2 2025, primarily due to a $16.5 million impairment charge in the prior period.
• Research and development expenses totaled a benefit of $0.8 million in Q2 2026, compared to $5.8 million in expenses in Q2 2025, due to additional Australian research and development rebates.
• The company's cash and cash equivalents were $18.4 million as of June 30, 2026, supplemented by an additional $4.2 million in Australian research and development tax rebates post-quarter end, supporting operations into Q2 2027.

Strategic Focus and Future Milestones:

• ImmuneBio plans to submit the Ebstracell MAA to the MHRA in the UK, followed by submissions to the EMA and FDA for conditional approval in 2027.
• The company is advancing the Expro registrational strategy and evaluating strategic partnerships, supported by FDA fast-track designation and alignment.
• The focus is on disciplined execution, completing high-quality submissions, and building capabilities for potential commercialization.

Sentiment Analysis:

Overall Tone: Positive

• Milestones 'materially de-risked' regulatory and operational path. 'Combination provides both a near-term regulatory opportunity and meaningful long-term pipeline value.' 'Execution... from clinical development toward regulatory review and potential commercialization.'

Q&A:

• Question from James Malloy (Alliance Global Partners): On the EPSTRA cell, the open-label Phase III U.S. trial, is that the 12-month open-label safety trial we discussed previously, or is this a different trial?
  Response: It is the same 12-month open-label safety and confirmation trial previously discussed, serving as the phase-three confirmatory trial required for conditional approval.

• Question from James Malloy (Alliance Global Partners): When you look at the UK filing or the EU filing... what do you think are the biggest hurdles... and how you've addressed those?
  Response: Primary endpoints of pain and itch are well-aligned with patient and regulatory priorities, supported by clinical data; regulators recognize itch as a key wound-healing factor.

• Question from James Malloy (Alliance Global Partners): What does the open-label confirmatory trial look like?... what's the size of the trial?
  Response: Trial expected to enroll ~40-45 patients (mostly from original trial), with data expected around mid-2028, involving three sessions of two infusions over 18 months.

• Question from James Malloy (Alliance Global Partners): What does a potential approval in the UK, what does a launch look like...?
  Response: Launch is positioned at two leading UK pediatric hospitals; expects to reach ~100 patients within two years post-approval, leveraging existing patient relationships.

• Question from Dan (compiled email): Can you just clarify that the company's focus for the foreseeable future is on the course and program...?
  Response: Focus is on the Cordstrom platform and Ebstracell program; UK market has ~800 patients, with pricing expected around £400k-500k per child per year.

• Question from Dan (compiled email): In light of recent positive developments, I'm stunned at the current share price... Would you care to comment?
  Response: Company is undervalued but must prove itself via regulatory approvals; orphan drug and rare pediatric disease designations could lead to a priority review voucher worth $100-200M.

• Question from Dan (compiled email): Can you go over the burn rate as well and sort of capital market strategy?
  Response: Burn rate is $1M-$1.5M per month (excluding one-time rebates); capital strategy involves cautious, judicious fundraising, with cash to Q2 2027, aiming for UK approval in early Q2 2027.

Contradiction Point 1

Trial Clarification and Regulatory Strategy

The company's messaging on the nature of its Phase III trial for Ebstracell has shifted, impacting clarity on regulatory requirements and potentially confusing investors about the trial's scope and necessary steps for approval.

James Malloy (Alliance Global Partners) - James Malloy (Alliance Global Partners)

2026Q2: The open-label confirmatory trial is the same 12-month safety and efficacy trial previously discussed; it is not an additional trial. - David Moss(CEO) & Mark Liddell(CSO)

Is the Ebstracell Phase III U.S. open-label trial the previously discussed 12-month safety study? - James Molloy (Alliance Global Partners)

2026Q2: It is the same trial. The open-label confirmatory trial serves as both a safety and efficacy confirmation study, with no separate 12-month safety trial required. - David Moss(CEO)

Contradiction Point 2

Regulatory Submission Timeline

The timeline for submitting a Marketing Authorization Application (MAA) for the UK has been pushed back significantly, which affects investor expectations regarding the pace of regulatory progress and potential revenue generation.

James Malloy (Alliance Global Partners) - James Malloy (Alliance Global Partners)

2026Q2: The trial is being run at the two leading UK hospitals for RDEB. With ~800 patients in the UK... the company expects to treat ~100 patients within two years of approval. - David Moss(CEO) & Mark Liddell(CSO)

What are the biggest hurdles for UK/EU approval of Ebstracell, how have you addressed them, and what does a potential UK approval and launch look like following the Phase III U.S. trial? - Dr. Mark Lowdell, CSO and Co-Founder, INmune Bio

2026Q1: Expect to file for approval beginning in the near term... expect to submit to MHRA in early Q3. - Dr. Mark Lowdell(CSO)

Contradiction Point 3

Cash Burn Rate and Funding Strategy

The projected timeline for cash sufficiency has extended, altering the strategic outlook for capital raising and funding operations, which is critical for maintaining investor confidence in financial planning.

Dan (Investor via Email) - Dan (Investor via Email)

2026Q2: Cash is expected to last into Q2 2027. Funding will be raised judiciously... with the goal of approval in the UK in early 2027... - Corey Elsperman(CFO)

Given recent positive developments, do you believe a proper repricing is warranted, and can you comment on the burn rate and capital market strategy? - Cory Ellspermann, CFO, INmune Bio

2026Q1: Cash is sufficient to fund operations through Q1 of 2027. - Cory Ellspermann(CFO)

Contradiction Point 4

Company Program Focus

The stated primary focus for creating value has shifted from executing specific regulatory filings to a broader acknowledgment of potential undervaluation, which may signal a lack of clear strategic prioritization.

Dan (Investor via Email) - Dan (Investor via Email)

2026Q2: The CEO acknowledges the company may be undervalued but emphasizes that the path to value is regulatory proof. - Corey Elsperman(CFO) & David Moss(CEO)

Given recent positive developments, do you believe a proper repricing is warranted, and could you comment on the burn rate and capital market strategy? - David Moss, CEO and Co-Founder, INmune Bio

2026Q1: Focus is straightforward: executing towards regulatory filings for CORDStrom, which is seen as a major inflection point. - David Moss(CEO)

Contradiction Point 5

U.S. FDA Submission Timeline and Pathway

The timeline for a major U.S. FDA submission has been revised from a specific near-term target to a more cautious, later date, creating uncertainty about the regulatory pathway and potential U.S. market entry.

Dan (Investor via Email) - Dan (Investor via Email)

2026Q2: The company is being prudent with capital... Cash is expected to last into Q2 2027. Funding will be raised... with the goal of approval in the UK in early 2027 and revenue generation thereafter. - Corey Elsperman(CFO)

Can you discuss the burn rate and capital market strategy? - Elemer Piros (Lucid Capital Markets, LLC)

2025Q4: The data and approach for the FDA submission are identical... The company plans to hold a pre-BLA meeting with the FDA... The full BLA submission is on track for late 2026. - Mark Lowdell(Chief Scientific Officer & Chief Manufacturing Officer) and David Moss(CEO)