8-K: INmune Bio Eyes BLA Submission for CORDStrom in RDEB by Year-End 2025; XPro Phase 2 Alzheimer's Data Expected in June

INmune Bio is advancing its pipeline with key milestones expected in 2025, including a BLA submission for CORDStrom in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and top-line results from the Phase 2 trial of XPro in Alzheimer's disease.

Summary

• INmune Bio is focused on developing therapies for inflammation and immunology.
• The company has three novel platforms: CORDStrom, XPro, and INKmune.
• CORDStrom has completed a blinded, randomized trial in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and showed clinical benefit.
• The company plans to submit a US BLA for CORDStrom in December 2025 and has been granted Orphan Drug and Rare Pediatric Disease Designations from the FDA.
• XPro is being developed to treat neuroinflammation without immunosuppression, and the Phase 2 Alzheimer's trial is fully enrolled with top-line cognition results expected in June 2025.
• INKmune is designed to create memory-like NK cells to kill cancer, with an open-label Phase 2 trial in Metastatic Castrate Resistant Prostate Cancer ongoing and data readouts expected in 2025.
• CORDStrom is a cell medicine comprising allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion.
• The Mission EB Phase 2 trial showed that CORDStrom was well-tolerated and had beneficial effects on itch, clinician score, skin score, and quality of life.
• The company intends to file an IND with the FDA to include US patients in an open-label trial set to begin in the UK around mid-2025.
• XPro is designed to neutralize soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF).
• The Phase 2 trial of XPro in patients with early Alzheimer's disease has a primary endpoint of EMACC and secondary endpoints including CDR-SB, ECog, ADL, NPI, blood, MRI, and safety.
• INKmune converts resting NK cells to cancer-killing memory-like NK cells.
• The company anticipates topline cognition data from the Phase 2 Alzheimer's trial in June 2025 and a BLA submission for CORDStrom in December 2025.

Sentiment

Score: 7

Explanation: The document presents a positive outlook with upcoming milestones and potential market opportunities. The focus on clinical benefits and regulatory pathways contributes to a favorable sentiment.

Positives

• CORDStrom has shown clinical benefits in RDEB patients, particularly in reducing itch.
• CORDStrom has received Orphan Drug and Rare Pediatric Disease Designations from the FDA, potentially leading to a Priority Review Voucher and seven years of market exclusivity.
• XPro targets neuroinflammation without causing immunosuppression, a potential advantage over existing TNF inhibitors.
• INKmune has the potential to convert resting NK cells into cancer-killing memory-like NK cells.
• The company has productive conversations with the FDA, establishing a clear path forward for CORDStrom.
• The company intends to file an IND with the FDA to include US patients in an open-label trial set to begin in the UK around mid-2025.
• CORDStrom is a revolutionary MSC drug with patent and manufacturing IP owned by INMB.
• CORDStrom is reproducible, tuneable, highly cost effective, manufactured at scale, has established MsOA & potency assays, and is truly Off The Shelf.

Negatives

• The document does not explicitly state any negatives.
• The document does not explicitly state any negatives.

Risks

• Forward-looking statements are subject to uncertainties, risks, and changes in circumstances that are difficult to predict.
• The company's ability to raise capital to fund continuing operations is a risk.
• Protecting intellectual property rights and the impact of infringement actions are potential risks.
• Competition from other providers and products could impact the company's success.
• The ability to develop and commercialize products and services is subject to risk.
• Changes in government regulation could impact the company.
• The ability to complete capital raising transactions is a risk.
• The document does not explicitly state any risks.

Future Outlook

The company anticipates key milestones in 2025, including top-line cognition data from the Phase 2 Alzheimer's trial in June and a BLA submission for CORDStrom in December. They also plan to submit MAAs to MHRA and EMA seeking approvals in the UK and EU in 2026, with potential approval/launch of CORDStrom in the US, UK, and EU in 2026.

Industry Context

The document mentions Krystal Biotech's VYJUVEK launch in DEB is off to an impressive start (~$84M net revenue in Q3 24), indicating a competitive landscape in the RDEB treatment market. CORDStrom is positioned as a potential first systemic therapy with itch benefit, differentiating it from existing treatments.

Comparison to Industry Standards

• Krystal Biotechs VYJUVEK launch in DEB is off to an impressive start (~$84M net revenue in Q3 24).
• The document references Lecanemab Phase III trial (C. van Dyck, et al, 2023 NEJM) in the context of EMACC and CDR as primary end-points for Early AD clinical trials.
• The document references Sims et al 2023, vanDyck et al 2003, Vargas Gonzalez et al 2024 in the context of EMACC as a stress test for the brain.

Stakeholder Impact

• Positive impact on RDEB patients through potential new treatment options.
• Potential benefits for Alzheimer's patients through XPro development.
• Opportunity for investors through potential market growth and product approvals.

Next Steps

• Submit BLA seeking approval of CORDStrom for the treatment of RDEB by YE 2025.
• Submit MAAs to MHRA and EMA seeking approvals in the UK and EU in 2026.
• Potential approval / launch of CORDStrom in the US, UK and EU in 2026.
• Open label trial set to begin in the UK around mid 2025; INmune intends to file IND with FDA to include US patients.

Key Dates

Keywords

CORDStrom, XPro, INKmune, RDEB, Alzheimer's disease, Neuroinflammation, Metastatic Castrate Resistant Prostate Cancer, Mesenchymal Stromal Cells, BLA, FDA, Clinical Trials, Immunology, Inflammation