INmune Bio's Q3 2025 Earnings Call: Contradictions Emerge on XPro Partnership Timeline, CORDStrom Regulatory Strategy, and Commercialization Plans

Guidance:

• MAA for CORDStrom targeted in the U.K. in mid-2026.
• BLA filing in the U.S. expected a few months after the MAA; FDA response potentially mid-2027 or later.
• XPro: additional MRI/imaging data expected in Q4 2025; pursuing accelerated pathway and end-of-Phase II meeting minutes in Q1 2026.
• Submit MHRA scientific advice package imminently to support MAA timeline.
• Cash runway sufficient to fund operations into Q4 2026.

Business Commentary:

* Focus on CORDStrom and Regulatory Milestones: - INmune Bio is advancing its CORDStrom platform, with plans to submit a Marketing Authorization Application (MAA) in the U.K. by Q2 2026 and a Biologics Licensing Application (BLA) with the FDA later in the year. - The focus on CORDStrom is driven by its potential systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB), with positive results demonstrated in reducing itch and improving patients' quality of life.

• XPro's Alzheimer's Disease Program and Future Pathway:
• INmune Bio is preparing for an end of Phase II meeting with the FDA for its XPro platform, aiming to establish a clear regulatory pathway for treating neuroinflammation in Alzheimer's disease.

• The company is pursuing an accelerated regulatory pathway, with upcoming imaging data expected to support the drug's potential benefits in myelin, gray matter, and white matter.

• INKmune's Prostate Cancer Trial and Partnering Possibilities:

• INKmune completed a Phase II trial in prostate cancer, meeting its primary and secondary endpoints, which included evidence of NK cell proliferation and memory-like NK cell generation.

• The company is exploring partnership opportunities for INKmune, considering further Phase II trials in prostate cancer and potentially other indications, depending on available funds.

• Financial Position and Cash Runway:

• INmune Bio reported cash and cash equivalents of approximately $27.7 million at the end of Q3 2025, with sufficient cash to fund operations into Q4 2026.
• The company's financial strength supports its ongoing research and development efforts, particularly for CORDStrom and XPro, as it advances towards key regulatory and clinical milestones.

Sentiment Analysis:

Overall Tone: Positive

• Management repeatedly stated optimism and progress: “we're highly optimistic,” CORDStrom “has demonstrated a clear and safe benefit,” XPro manuscript submitted and pursuing accelerated pathway, and planned MAA/BLA filings and multiple near-term catalysts (MAA mid-2026, imaging/Q1 ’26 FDA minutes). Cash runway to Q4 2026 supports execution.

Q&A:

• Question from Denis Reznik (Raymond James Ltd., Research Division): As you're preparing for the end-of-Phase-II meeting with the FDA for XPro, what are the biggest discussion topics you expect and why was the meeting timing pushed from year-end to 1Q?
  Response: Meeting timing shifted because not enough data were finalized; primary FDA discussion points will be enrichment biomarkers (inflammation-driven patient selection), EMACC, safety database size and registration trial design—aiming for alignment in Q1 with written minutes ~30 days after.

• Question from Denis Reznik (Raymond James Ltd., Research Division): How are partnership conversations for XPro progressing versus last quarter, and what is the company's plan for INKmune—internal development or partnering?
  Response: Partner talks remain preliminary; potential partners want regulatory alignment and fuller datasets (imaging); INKmune will move toward a randomized Phase II in prostate and be positioned for partnership discussions though the company may retain if funding permits.

• Question from Jason Mccarthy (Maxim Group LLC, Research Division): Any feedback from European regulators ahead of an MAA filing? Will a U.K. MAA support a U.S. BLA? Also please discuss CORDStrom's cytokine-activation mechanism and how the platform differs from other MSC therapies.
  Response: Expect MHRA scientific-advice engagement soon and are targeting a U.K. MAA in Q2 2026 which they expect to inform a subsequent BLA; CORDStrom is differentiated by pooled-cord donor selection and cytokine-activated, targeted systemic anti-inflammatory activity plus a manufacturing approach designed for batch consistency to support regulatory review.

• Question from Unknown Analyst (AGP Alliance Global Partners): How would CORDStrom fit into the U.K. RDEB treatment paradigm (given existing approvals), is there evidence of systemic symptomatic relief beyond skin, and what is your cash runway relative to these milestones?
  Response: There is no NICE‑reimbursed RDEB therapy in the U.K., creating demand; independent analyses and published data indicate systemic cytokine changes and patient-reported quality‑of‑life improvements (more data forthcoming); cash on hand (~$27.7M at 9/30/25) funds operations into Q4 2026 to support near-term milestones including MAA preparation.

Contradiction Point 1

XPro Partnership Timeline

It involves the timeline for potential partnerships for XPro, which is critical for the company's strategy and financial planning, impacting funding and development of the asset.

Could you update on XPro partnership progress? And how do you plan to develop INKmune—in-house or through a partner? - Jason Mccarthy (Maxim Group LLC, Research Division)

2025Q3: We anticipate partnerships for XPro after the end of Phase II meeting with the FDA, likely in 2026 or 2027. - David J. Moss(CEO)

How is the progress of strategic partnerships to accelerate XPro? What specific criteria are you seeking in a partner, and what does an ideal partnership look like financially? Is a partnership likely to be announced before the FDA meeting? - Denis Reznik (Raymond James)

2025Q2: We aren't expecting partnerships until after the end of Phase II meeting with the FDA. - David J. Moss(CEO)

Contradiction Point 2

CORDStrom Regulatory Pathway and Strategy

The regulatory strategy for CORDStrom is crucial for the company's plans to commercialize the product and gain market access.

What is the current treatment paradigm for RDEB in the U.K., and how does CORDStrom fit in? - Unknown Analyst (AGP Alliance Global Partners)

2025Q3: We're in discussions with the agencies and expect to be able to talk to you about those in the future. - Mark Lowdell(CSO)

Are you anticipating new insights from statistical analysis during BLA submission preparations? Could you share key details about the planned open-label post-BLA trial of CORDStrom? - Boris Tolkachev (Freedom Broker)

2025Q2: We're awaiting a scientific meeting with the MHRA for CORDStrom, with a potential submission in early January. We expect the MHRA to provide feedback to support a BLA filing in the U.S. later in the year. - Mark Lowdell(CSO)

Contradiction Point 3

Meeting Schedule for End of Phase II on XPro

It involves the timeline and expectation for key regulatory meetings, which can impact the development and approval process of a critical drug candidate.

What are the key topics you're seeking clarity on ahead of the Phase II end meeting with the FDA regarding XPro, and why was the meeting delayed from year-end to Q1 2026? - Denis Reznik (Raymond James Ltd., Research Division)

2025Q3: We believe we'll get the meeting in Q4. We're a little conservative in guiding to Q1. But the data on our meeting on XPro should occur within the next 30 days. - David Moss(CEO)

Is the 12-month open-label trial required for filing the RDEB program, and do FDA and UK approval have different requirements? - George Farmer (Scotiabank)

2024Q4: We're preparing for an End of Phase II meeting with the FDA on XPro in the fourth quarter of this year. - David Moss(CFO)

Contradiction Point 4

CORDStrom Regulatory Pathway and Strategy

It involves differences in the company's approach and strategy regarding the regulatory pathway for CORDStrom, which could influence the timeline and resources required for market approval.

Have European regulators provided feedback on the CORDStrom MAA filing? Would filing the MAA support FDA regulators? - Jason Mccarthy (Maxim Group LLC, Research Division)

2025Q3: Potential submission in early January. We expect the MHRA to provide feedback to support a BLA filing in the U.S. later in the year. - Mark Lowdell(Chief Scientific Officer)

Will the 12-month open-label CORDstrom trial start this year? Enrollment target and U.S. site count for the trial? - Laura Suriel (Alliance Global Partners)

2025Q1: The BLA submission is not dependent on U.S. trials, with a U.K. double-blind placebo-controlled trial providing data for the BLA. - Dr. Mark Lowdell(CSO)

Contradiction Point 5

Partnership and Commercialization Plans for CORDStrom

It relates to strategic decisions on whether to pursue commercialization independently or through partnerships, which can significantly impact the company's operational and financial strategies.

Can you update us on the progress of partnership discussions for XPro? And what is your strategic approach for INKmune—developing it internally or pursuing partnerships? - Denis Reznik (Raymond James Ltd., Research Division)

2025Q3: Investors want to see regulatory feedback before they think about partnering. - David Moss(CEO)

What are the commercialization plans for CORDStrom, and will it be handled in-house or via a partner? - Denis Reznik (Raymond James)

2024Q4: Our goal is to commercialize CORDStrom ourselves, but we expect to partner with distribution and marketing experts as we approach that point. - David Moss(CFO)