Vivo Empowers Clinical Development Teams to Accelerate Decision-making and Analyses in Clinical Trials for Improved Outcomes HOUSTON and BOCA RATON, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- OmniScience and INmune Bio (NASDAQ: INMB) today announced a pioneering partnership to revolutionize operations for INmune Bio’s global Phase 2 Alzheimer’s disease (AD) clinical trial (the “AD02 trial”) using OmniScience’s flagship product, Vivo, an industry-first, genAI-powered control tower designed specifically for cent ...

Financial Performance - Net loss attributable to common stockholders for Q3 2024 was approximately $12.1 million, compared to $8.6 million in Q3 2023, representing an increase of 40.7%[17] - Total revenue for the nine months ended September 30, 2024, was $30,000, compared to $43,000 for the same period in 2023, representing a decrease of 30.23%[29] - Net loss for the nine months ended September 30, 2024, was $32,864, compared to a net loss of $21,600 for the same period in 2023, reflecting an increase of 52.00%[31] - The company reported a net cash used in operating activities of $22,348 for the nine months ended September 30, 2024, compared to $8,579 for the same period in 2023, an increase of 160.00%[31] Research and Development - Research and development expenses totaled approximately $10.1 million for Q3 2024, up from approximately $6.0 million in Q3 2023, indicating a year-over-year increase of 68.3%[17] - Research and development expenses for the nine months ended September 30, 2024, were $25,813, up from $14,266 in the same period of 2023, marking an increase of 81.00%[29] - The Phase 2 Alzheimer's trial (AD02) has completed enrollment with a target of 201 patients, with interim analysis showing a highly significant correlation (p<0.001) between EMACC and CDR-SB[2][3] - INKmune™ demonstrated excellent safety and increased NK-Cell activity in the Phase I/II trial for metastatic Castration-Resistant Prostate Cancer, with 2 of 3 patients showing increased circulating activated NK cells[7] - The CaRe PC trial has recently dosed the first patient in the highest dose cohort, with the intermediate and high dose cohorts being 3 and 5 times the initial dose[9] - Top-line data from the Phase 2 Alzheimer's trial is expected in Q2 2025, with a Phase II trial of XPro™ in Treatment-Resistant Depression set to initiate in 2H 2024[14] - The company received a $2.5 million research and development rebate from Australia in July 2024[13] Cash and Equity - As of September 30, 2024, the company had cash and cash equivalents of approximately $33.6 million[18] - Cash and cash equivalents at the end of the period were $35,848, down from $52,153 at the end of the same period in 2023, indicating a decrease of 31.36%[31] - The company executed securities purchase agreements for gross proceeds of approximately $13.0 million[13] - The company had total liabilities of $14,107 as of September 30, 2024, down from $18,862 at the end of 2023, a decrease of 25.51%[28] - Total stockholders' equity increased to $38,675 as of September 30, 2024, from $37,340 at the end of 2023, reflecting an increase of 3.59%[28] - As of October 31, 2024, the company had approximately 22.2 million common shares outstanding[18] - The weighted average common shares outstanding for the nine months ended September 30, 2024, were 19,176,853, compared to 17,966,990 for the same period in 2023, an increase of 6.71%[29] - The company reported net proceeds from the sale of common stock and warrants of $27,789 for the nine months ended September 30, 2024, compared to $775 for the same period in 2023, a significant increase[31] Operating Expenses - Operating expenses for the nine months ended September 30, 2024, totaled $33,182, an increase of 54.38% from $21,489 in the same period of 2023[29]

BOCA RATON, Fla., Oct. 31, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2024 and provides a business update. Q3 2024 and Recent Corporate Highlights   DN-TNF Platform Highlights (XPro™): Announced completion enrollment for its Phase 2 Alzheimer’s Disease (“A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38793 | --- | --- | --- | |------------------------------------------------------|--------------------------------------------------------------------------- ...

Core Insights - INmune Bio, Inc. has published a study demonstrating that XPro1595 promotes remyelination in an animal model of demyelinating disease, with implications for various CNS diseases including Alzheimer's [1][2] - The study identifies soluble TNF as a critical cytokine checkpoint that can convert microglia from a reparative to a damaging state, suggesting that blocking soluble TNF may be a promising strategy for treating demyelinating diseases [2] - INmune Bio anticipates reporting top-line cognitive results from an ongoing Phase II trial in early Alzheimer's patients in the first half of 2025 [2] Company Overview - INmune Bio, Inc. is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [4] - The company has two product platforms in clinical trials: the Dominant-Negative Tumor Necrosis Factor (DNTNF) platform and the Natural Killer Cell Priming Platform [4] - XPro1595 is the first product from the DNTNF platform, currently in trials for Mild Alzheimer's disease, with plans to explore additional indications such as treatment-resistant depression and oncology [4] Demyelination in Alzheimer's Disease - Research indicates that demyelination occurs in brain regions critical for cognition in Alzheimer's patients, often associated with amyloid-beta plaques [3] - Myelin loss may precede or accompany classic pathological changes in Alzheimer's, with alterations in myelin density detectable before typical symptoms arise [3] - Mechanisms of myelin damage in Alzheimer's involve oligodendrocyte dysfunction, contributing to a feedback loop that exacerbates both myelin loss and neurodegeneration [3]

Management to host conference call and webcast at 4:30 pm ET on that day Boca Raton, Florida, Oct. 24, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the “Company”),  a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), today announced that it will host a conference call on Thursday October 31, 2024, at 4:30pm EDT to discuss results for its quarter ended September 30, 2024 and to provide a corporate upda ...

Boca Raton, Florida, Oct. 11, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer's Disease (AD), today announced that management will participate in the upcoming Maxim Healthcare Virtual Summit, to be held October 15-17, 2024. 2024 Maxim Healthcare Virtual Summit October 15, 2024 Format: Fireside Chat, 1-on-1 virtual meetings Presentation Time: 12:20 PM Eas ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

BOCA RATON, Fla., Sept. 26, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic CastrationResistant Prostate Cancer (mCRPC). The Company is pleased to announce initial results from the first patient cohort in the trial. Mark Lowdell, CSO and inventor of INKmune™, said, "The enrollment of the first c ...

Core Insights - INmune Bio Inc. announced exceptional performance of the EMACC cognitive measure in its AD02 Phase II Alzheimer's Disease trial, showing a significant correlation with the CDR-SB endpoint [1][3][4] Group 1: EMACC Performance - The analysis confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, which is the most commonly used clinical rating scale in Alzheimer's Disease registration studies [3] - EMACC demonstrated a reliability correlation of 0.93 when measured during screening and at the first study visit before treatment, indicating high precision and robustness [3] - EMACC effectively differentiated between patients with prodromal AD (CDR global rating of 0.5) and mild dementia (CDR rating of 1.0), with an effect size (Cohen's d) of 0.87 (p<.0001) [3] Group 2: Clinical Trial Insights - The novel design elements in the AD02 Phase II trial are believed to significantly de-risk the clinical program compared to traditional trial designs in Alzheimer's drug development [4] - EMACC is positioned as the primary endpoint in the trial, which aims to measure cognitive changes in early AD patients with biomarkers of inflammation [4] - Enrollment is expected to be completed by the end of the current quarter, with topline data anticipated approximately six months after the last patient is enrolled [4] Group 3: About EMACC - EMACC is an empirically derived cognitive measure that combines standardized neuropsychological tests, showing the greatest sensitivity to change in early Alzheimer's Disease patients over two years [5] - The performance characteristics of EMACC were first reported by Biogen at CTAD in 2021 and were found to be strongly associated with biological markers of inflammation [5] Group 4: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [9] - The company has two product platforms in clinical trials: the DN-TNF product platform and the Natural Killer Cell Priming Platform, aimed at treating various diseases including cancer and chronic inflammation [9]