INmune Bio(US:INMB)2025-10-30 20:10Product Development and Clinical Trials - The company aims to develop and commercialize product candidates targeting diseases related to inflammation and immunology, with a primary focus on Alzheimer's Disease (AD) and recessive dystrophic epidermolysis bullosa (RDEB) [102]. - XPro for AD has completed Phase I and Phase II trials, with the Phase II trial involving 208 patients and top-line data expected in June 2025 [103][109]. - In the Phase II trial, the modified intent-to-treat (mITT) population did not meet primary and key secondary endpoints, with no decline observed in the placebo group [109][112]. - The enriched subgroup of patients, defined as amyloid positive with a higher burden of inflammation, showed a beneficial effect of XPro on cognitive measures, with an effect size of 0.27 for the Early and Mild Alzheimer's Cognitive Composite (EMACC) [115][120]. - XPro demonstrated a significant reduction in neuroinflammation biomarkers, including a 91% reduction in Visinin-like protein-1 and an 84% reduction in Neurofilament light [106]. - The Phase II study was a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of XPro1595 in early AD patients with inflammatory biomarkers [108]. - The company believes that neutralizing soluble TNF (sTNF) is crucial for treating neuroinflammation and immune dysfunction in AD [104]. - The company is focused on leveraging its DN-TNF platform to treat selected neurodegenerative diseases without immunosuppression [106]. - The Phase I trial of XPro was partially funded by a Part-the-Clouds Award from the Alzheimer's Association, indicating external validation of the research [106]. - The Phase 2 results suggest XPro may benefit a subgroup of Alzheimer's patients with biomarker-defined neuroinflammation, regardless of comorbidities or ApoE4 status [127]. Product Applications and Regulatory Designations - The company plans to submit a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) with the FDA in the US for CORDStrom in 2026 [103]. - CORDStrom platform utilizes proprietary techniques to produce off-the-shelf, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (HucMSCs) for treating complex inflammatory diseases [128]. - Approximately 2,000 individuals in the US, UK, and EU suffer from RDEB, representing a significant unmet medical need [130]. - CORDStrom demonstrated a sustained reduction of over 27% in itch severity at 6 months for patients with severe disease activity [132]. - The FDA granted Rare Pediatric Disease Designation (RPDD) to CORDStrom on December 13, 2024, making it eligible for a Priority Review Voucher [137]. - The FDA also granted Orphan Drug Designation (ODD) to CORDStrom on January 6, 2025, providing benefits such as tax credits and market exclusivity [138]. - The Company plans to submit a Biologics License Application (BLA) for CORDStrom this year, with submissions to the EU and UK planned for 2026 [139]. Financial Performance - The company reported a net loss of $40.7 million for the nine months ended September 30, 2025, compared to a net loss of $32.9 million for the same period in 2024 [165]. - Research and development expenses were approximately $18.3 million for the nine months ended September 30, 2025, down from $25.8 million in the same period in 2024, primarily due to a $9.5 million reduction in Alzheimer's clinical program expenses [160]. - The company recognized revenue of $50,000 during the nine months ended September 30, 2025, compared to $14,000 in the same period in 2024 [158]. - Total operating expenses for the nine months ended September 30, 2025, were $41.96 million, an increase of $8.78 million from $33.18 million in 2024 [158]. - The company incurred a significant impairment of $16.5 million related to acquired in-process research and development intangible assets due to the failure of the Phase 2 clinical trial for the Alzheimer's drug candidate [162]. - Cash and cash equivalents as of September 30, 2025, were $27.7 million, up from $20.9 million as of December 31, 2024 [142]. - The company expects to continue incurring significant losses and increasing operating expenses as it advances its product candidates through clinical development [151]. - General and administrative expenses were approximately $7.1 million for the nine months ended September 30, 2025, compared to $7.4 million in the same period in 2024 [161]. - The company recorded $1.24 million of other income during the nine months ended September 30, 2025, compared to $304,000 in the same period in 2024 [163]. Financing and Cash Flow - The company plans to finance its operations through equity and debt financing, as well as potential collaborations and government funding [143]. - The Company sold 1,304,707 shares of common stock at an average price of $8.01, generating gross proceeds of approximately $10.4 million under the ATM offering during the nine months ending September 30, 2025 [166]. - In June 2025, the Company sold 3,000,000 shares of common stock in a registered direct offering for gross proceeds of $18.9 million, with net proceeds of approximately $17.4 million [166]. - Cash and cash equivalents at the end of the period were $27.7 million, with total current assets of $30.7 million, projected to be insufficient to sustain operations for one year following the issuance of financial statements [169]. - Operating activities used approximately $19.6 million of cash during the nine months ended September 30, 2025, primarily due to a loss of $40.7 million [174]. - The Company incurred $0.9 million in equipment acquisitions for its CORDStrom clinical program during the nine months ended September 30, 2025 [176]. - Financing activities generated $27.5 million during the nine months ended September 30, 2025, compared to $20.3 million in the same period of 2024 [173]. - The Company reported a net cash outflow from operating activities of $22.3 million for the nine months ended September 30, 2024 [175]. - The Company has significant research and development expenses in Australia and the United Kingdom, with foreign currency fluctuations potentially impacting financial results [168]. - The Company anticipates financing operations through public or private equity sales, debt financing, or other capital sources due to ongoing net losses and negative cash flows [169]. - The Company has raised concerns regarding its ability to continue as a going concern within one year after the issuance of its financial statements due to recurring net losses [169].