CORDStrom: Positive Clinical Efficacy and Safety in RDEB
Randomized placebo-controlled data showed clinically meaningful wound healing, reductions in itch, improvements in quality of life and a favorable safety profile for CORDStrom in RDEB; company expects to file a U.K. MAA by mid-summer 2026 and to submit EMA and U.S. (BLA) applications by end of 2026 with potential supply to patients in 2027.
CORDStrom: Manufacturing Consistency and Mechanism of Action
Demonstrated batch-to-batch manufacturing reproducibility from pooled donor MSC banks, established potency assays and elucidated a MOA (M1-to-M2 macrophage modulation and IL-10 induction) — key CMC and regulatory enablers for filings and commercialization.
XPro (Alzheimer's): Encouraging Signal and FDA Alignment for Phase III
MINDFuL data 'consistently favored' XPro across clinical, behavioral, patient-reported, blood and imaging biomarkers; company received End-of-Phase-II meeting minutes from FDA and aligned on an adaptive Phase III design (Phase IIb decision at 9 months, registrational 18-month primary endpoint using CDR-SB).
INKmune: Phase II Success in mCRPC
Completed Phase II in metastatic castration-resistant prostate cancer ahead of schedule and under budget; the study met its primary endpoint and 2 of 3 secondary endpoints, supporting further development/BD opportunities.
Reduced R&D Spend in 2025
Research and development expenses decreased to $20.7M in 2025 from $33.2M in 2024, a reduction of approximately 37.7%, primarily due to lower Alzheimer's trial expenses — improving near-term capital efficiency.
Near-term Financing Achieved
Raised net proceeds of approximately $27.5M during 2025 through a $17.4M registered direct offering (3.0M shares) and ~$10.1M from at-the-market sales (~1.3M shares), extending runway toward planned milestones.