INmune Bio's Q3 2025: Contradictions Emerge on EXPRO Phase 2 Timeline, Partnership Strategy, and CORDstrom BLA Delays

Guidance:

• File Cordstrom MAA in the UK in mid-2026 and submit a BLA in the US a few months after; FDA response could arrive by mid‑2027.
• Expect FDA decision on accelerated pathway and end-of-Phase-2 meeting minutes in Q1 2026.
• Provide additional Mindful MRI/imaging data in Q4 2025 to support myelin, gray- and white-matter findings.
• Seek regulatory alignment and design for EXPRO registration study; pursue partnerships contingent on regulatory/data package.
• Cash runway sufficient to fund operations into Q4 2026 per current plan.

Business Commentary:

* Cordstrom and RDEB Program: - INmune Bio's Cordstrom demonstrated significant reductions in itch for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB), with no severe adverse reactions reported during over 120 infusions. - This success is attributed to Cordstrom's ability to target inflammatory cytokines at the site of itch and wound, effectively breaking the itch-scratch-wound cycle, which traditionally impedes wound healing in these patients.

• EXPRO and Alzheimer's Disease:
• Results from the Phase 2 Mindful trial for EXPRO showed positive outcomes in patients with higher baseline inflammation, indicating potential benefits in treating neuroinflammation in Alzheimer's disease.

• The findings were derived from analyzing the complete data set, revealing improvements in neuropsychiatric symptoms and changes in inflammatory biomarkers, which supports the exploration of an accelerated regulatory pathway.

• Financial Performance and Cash Runway:

• INmune Bio reported a net loss of approximately $6.5 million for Q3 2025, compared to approximately $12.1 million for the same period in 2024.

• The improvement in financial performance is due to reduced research and development expenses, with cash and cash equivalents at approximately $27.7 million, expected to fund operations into Q4 2026.

• Incuboom Trial Completion:

• The Phase 2 trial of Incuboom in prostate cancer was completed ahead of schedule, meeting its primary endpoint and two of the three secondary endpoints.

• The trial's success was based on evidence of NK cell proliferation and the generation of functional memory-like NK cells, indicating potential for further development in this and other disease areas.

• Regulatory and Partnering Strategies:

• INmune Bio aims to submit Marketing Authorization Applications (MAAs) for Cordstrom in the UK and US in mid-2026, with a focus on aligning regulatory strategies globally.
• Active discussions with potential partners are ongoing for EXPRO, with expectations of presenting more detailed partnership progress in upcoming quarters.

Sentiment Analysis:

Overall Tone: Positive

• Management repeatedly expressed optimism: “We’re highly optimistic… the next couple of years will demonstrate the success” and highlighted near-term regulatory milestones (UK MAA mid‑2026, FDA end‑of‑Phase‑2 Q1 2026). CFO: cash sufficient into Q4 2026 and net loss narrowed vs prior year.

Q&A:

• Question from Denis Reznik (Raymond James, on for Gary Nachman): On EXPRO, as you prepare for the end-of-Phase-2 meeting with the FDA, what are the biggest questions/discussion topics you want clarity on, and why did the meeting timing slip from before year-end to Q1?
  Response: Meeting likely slipped to Q1 because more data were needed; core FDA discussion points are enrichment biomarkers (patients with higher inflammation), EMAC, the safety database size, and alignment on a registration study design.

• Question from Denis Reznik (Raymond James, on for Gary Nachman): How are partnership conversations progressing compared with last quarter, and for Incuboom do you plan to advance it internally or seek a partner?
  Response: Partnership talks are high-level and contingent on regulatory alignment and additional data (imaging/biomarkers); for Incuboom the company will seek partners first and may retain development depending on funding, targeting a randomized Phase 2 when resources permit.

• Question from Jason McCarthy (Maxim Group): Have you received any specific feedback from European regulators regarding a potential MAA filing, would an MAA support US regulators, and can you explain the cytokine-activated mechanism and how Cordstrom differs from other MSC therapies?
  Response: Expect a scientific advice meeting with MHRA (possibly early next year) and remain on track to submit a UK MAA in Q2 2026; MHRA engagement should inform the subsequent US BLA, and Cordstrom's differentiation is cytokine-activated, targeted activity plus donor-pool selection enabling indication-specific potency and scalable manufacturing.

• Question from Matt (Alliance Global Partners, on for James Molloy): What is the current UK treatment paradigm for RDEB and where would Cordstrom slot in; any evidence of systemic symptomatic relief (e.g., mucosal wounds); and where does cash runway get you on milestones?
  Response: There is no NHS‑reimbursed RDEB therapy in the UK so Cordstrom could fill a major unmet need; published and investigator data (and patient anecdotes) indicate systemic effects including itch reduction; cash on hand is expected to fund operations into Q4 2026.

Contradiction Point 1

EXPRO Phase 2 Meeting Timeline

It involves changes in the expected timeline for the EXPRO Phase 2 meeting with the FDA, which affects regulatory milestones and potential collaborations.

What are the key questions or discussion topics you hope to clarify ahead of the end of Phase 2 FDA meeting, and why did the guidance shift from before year-end to Q1? - Denis Reznik (Raymond James)

2025Q3: We anticipated getting everything together, but we weren’t able to get enough of the data in time to really get to the FDA to have the meeting at the end of Q4. However, we're very close, and it still could happen. We're being relatively conservative, saying in Q1, which is not only the period of time you have the response from the FDA, but the 30 days to get the written minutes. - David Moss(CEO)

Has the specific date for the Phase II meeting with the FDA for XPro been set yet? Have there been any changes to the FDA contacts? - Denis Reznik (Raymond James)

2025Q2: The end of Phase II meeting should fall sometime in November or December if we get it in on our target date. - David J. Moss(CEO)

Contradiction Point 2

Partnership Strategy for EXPRO

It involves changes in the strategy regarding partnerships for EXPRO, which could impact funding and the company's ability to move the program forward.

How are EXPRO partnerships progressing, and how does the conversation tone compare to last quarter's? - Denis Reznik (Raymond James)

2025Q3: There have been very top-level discussions with a handful of groups. Our investors want to see what the regulatory feedback and alignment looks like, and they want to see more of the data set. - David Moss(CEO)

How is the XPro partnership progressing? What specific criteria and ideal financial terms are you seeking for a partner? Will the partnership be announced before or after the FDA Phase II meeting ends? - Denis Reznik (Raymond James)

2025Q2: I don't expect the partnership to occur until after the end of Phase II meeting with the FDA. - David J. Moss(CEO)

Contradiction Point 3

CORDstrom in the U.S. and U.K.

It involves the timeline and approach for CORDstrom's development and trials in the U.S. and U.K., which could impact the company's regulatory strategy and market access.

How are partnership conversations for EXPRO progressing compared to last quarter's tone? Separately, what are your plans for Incuboom's future development - will you pursue it independently or consider partnerships? - Denis Reznik (Raymond James)

2025Q3: We are planning to submit an IND in the U.S. later this year, but the BLA for CORDstrom is not dependent on the U.S. IND. We expect to further explore dosing and periodicity in the U.S. in parallel with U.K. trials. - Dr. Mark Lowdell(CSO)

Will you initiate the 12-month open-label trial for CORDstrom this year, and how many U.S. sites are expected to be open? - Laura Suriel (Alliance Global Partners)

2025Q1: We are planning to submit an IND in the U.S. later this year, but the BLA for CORDstrom is not dependent on the U.S. IND. We expect to further explore dosing and periodicity in the U.S. in parallel with U.K. trials. - Dr. Mark Lowdell(CSO)

Contradiction Point 4

EXPRO Partnership Conversations and Data Availability

It involves the progress and nature of partnership conversations for EXPRO, which could influence the company's strategic direction and financial prospects.

Regarding EXPRO partnerships, can you provide an update on their progress? - Denis Reznik (Raymond James)

2025Q3: There have been very top-level discussions with a handful of groups. Our investors want to see what the regulatory feedback and alignment looks like, and they want to see more of the data set. - David Moss(CFO)

Can you provide details on the discussions with potential partners? - Vivek Arya (Bank of America Securities)

2024Q4: The discussions that we’ve had with probably a dozen companies have all been very positive, seen a lot of interest. - David Moss(CFO)

Contradiction Point 5

CORDStrom BLA Submission Timeline

It involves the timeline for CORDStrom's BLA submission, which is a critical regulatory milestone for the product's approval and market launch.

Where have the biggest challenges been and how are you addressing them? - James Molloy (Alliance Global Partners)

2025Q3: We're anticipating and we’ve been trying our hardest to get it by the end of the year. We’ve been frustrated by the data delivery. - Dr. Mark Lowdell(CSO)

What is the status of the CORDStrom PRV program and are there potential timing issues? - James Molloy (Alliance Global Partners)

2024Q4: BLA submissions in the first half of 2026. We expect to have all necessary data by then. - Dr. Mark Lowdell(CSO)