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INmune Bio(INMB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
XPro Program for Alzheimer's Disease - XPro1595 is designed to selectively inhibit soluble TNF to treat neurologic disease, with Phase 1b study demonstrating safety and dose-dependent reduction in inflammatory cytokines in cerebrospinal fluid (CSF)[34] - A Phase 2 study of XPro1595 in early Alzheimer's patients with biomarkers of inflammation used an enriched population (n=100) with amyloid and ≥ 2 biomarkers of inflammation, showing a beneficial signal across multiple measures[42, 57] - In the Safety Analysis Set (SAF) population (n=206) for the Phase 2 study, 51% were female, and 95.1% were white[39] - In the mITT population (n=200), 75% were Amyloid-beta (Aβ) positive[39] - The most common Treatment Emergent Adverse Event (TEAE) in the XPro1595 group was Injection Site Reaction (ISR), occurring in 52.5% of patients[54] - The company plans to validate the enriched population in a fully powered trial and anticipates an end-of-Phase 2 meeting with the FDA in Q4 2025[56, 59] CORDStrom Program for RDEB - CORDStrom is an investigational disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic disease affecting an estimated 4000 people in the US, UK, and EU, representing a > $1B peak sales opportunity[64] - A Phase 2 trial of CORDStrom in 30 pediatric patients with RDEB showed beneficial effects with respect to Itch Man Scale, iscorEB clinician score, skin score, and QOL, with no CORDStrom-related serious adverse events reported[66] - The company plans to compile and file a BLA in the US & MAA in UK/EU in 1H 2026[77] INKmune Program for Cancer - INKmune is an off-the-shelf NK cell therapy candidate designed to convert patient's resting NK cells into cancer-killing memory-like NK cells[78] - An INKmune® mCRPC Phase I/II Trial is ongoing, with safety endpoints met and evidence of in-vivo NK cell activation and regression of some tumor lesions by PSMA-PET[80]
INmune Bio: Thinking Through XPro's MINDFuL Data In Early Alzheimer's
Seeking Alpha· 2025-07-05 03:48
Core Insights - INmune Bio (NASDAQ: INMB) has been part of the "Bio Boom" speculative portfolio since September 2023, with no changes made to its position despite the company's progress [2] Group 1 - The company has not seen any adjustments in its investment thesis since its inclusion in the portfolio [2] - The leader of the investing group Compounding Healthcare focuses on innovative companies developing breakthrough therapies and pharmaceuticals [2] Group 2 - The analyst holds a beneficial long position in INMB shares, indicating confidence in the company's potential [3]
Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain
Benzinga· 2025-06-30 15:52
Core Insights - INmune Bio Inc. is experiencing a significant decline in stock price, trading down 59% at $2.14, with a session volume of 23.2 million shares compared to an average of 1.45 million shares [1][5] - The company announced results from its Phase 2 MINDFuL trial for XPro, a selective soluble TNF inhibitor aimed at early Alzheimer's Disease, which showed cognitive benefits in a specific subpopulation despite not meeting the primary endpoint in the modified intent-to-treat population [2][4] Trial Results - The MINDFuL trial enrolled 208 participants, with the primary endpoint being the change in cognition over 6 months measured by the Early Mild Alzheimer's Cognitive Composite (EMACC) [3] - Although the primary endpoint was not met in the mITT group, significant benefits were observed in a subpopulation of patients with two or more biomarkers of inflammation [4] - Key findings indicated a cognitive benefit for XPro over placebo on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [5] Future Plans - The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in Q4 2025 to discuss the path for a pivotal trial to support XPro's approval in early Alzheimer's Disease [5] - INmune Bio announced a registered direct offering of 3 million shares at $6.30 per share, aiming for approximately $19 million in gross proceeds to be used for working capital and general corporate purposes [4][5]
INmune Bio(INMB) - 2024 Q4 - Earnings Call Transcript
2025-03-28 00:15
Financial Data and Key Metrics Changes - INmune Bio raised $29.9 million from the sale of common stock and warrants in 2024, issuing a total of 4,145,978 shares and warrants for 3,898,852 shares [37][38] - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023 [40] - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [40] - Cash and cash equivalents at December 31, 2024, were approximately $20.9 million, with an additional $5.4 million raised since year-end [41] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease is expected to announce top-line data in less than 100 days, focusing on neuroinflammation as a primary driver of the disease [8][14] - The INmune platform has pivoted to target solid tumors, with ongoing trials for castrate-resistant metastatic prostate cancer [17][18] - CORDStrom, a new therapeutic platform, is positioned to address systemic disease modification for RDEB, differentiating itself from local wound management therapies [22][24] Market Data and Key Metrics Changes - The ADO2 trial enrolled 208 patients across eight countries, with a focus on those with neuroinflammation driving their Alzheimer's disease [15] - The CaRe PC trial for prostate cancer is progressing, with completion of dosing in the Phase 1 part and ongoing Phase 2 dosing expected to complete by 2025 [18][43] Company Strategy and Development Direction - INmune Bio aims to challenge the amyloid-centric paradigm of Alzheimer's treatment by focusing on neuroinflammation [14][33] - The company is committed to advancing its three therapeutic platforms, with a focus on achieving regulatory milestones and potential commercialization [36][45] - The management emphasizes a precision medicine approach in clinical trials, particularly in the ADO2 trial [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [34][35] - The company believes that addressing neuroinflammation could have broader implications for various CNS diseases [35] - Management highlighted the importance of safety in treating elderly patients with Alzheimer's, noting no significant adverse events reported thus far [31] Other Important Information - The company plans to file a BLA for CORDStrom in the first quarter of 2026, which would mark its first market therapeutic [44][112] - Management is focused on ensuring the quality of regulatory submissions to facilitate successful approvals [113] Q&A Session Summary Question: Is the 12-month open label trial for RDEB required for filing? - Management indicated that they believe the current data is adequate for a BLA submission, but the FDA will ultimately decide [50][51] Question: Will EMACC and CDR results be released at the same time? - Management confirmed that both EMACC and CDR results will be available at the time of data release [56][60] Question: Are there any dropouts in the EXPAREL Phase 2 trial? - Management reported that dropouts are within expected ranges, primarily due to typical issues associated with elderly patients [86] Question: How does the company plan to commercialize CORDStrom? - Management aims to move towards commercialization independently but may seek a partner closer to the launch [93] Question: Will the BLA for CORDStrom be filed in the UK and US? - Management confirmed that they expect to have all necessary data ready for filing in both regions by early 2026 [101][102]