INmune Bio Inc. - INMB STOCK NEWS

INmune Bio, Inc. (NASDAQ: INMB) announced it has received approximately $6.4 million in R&D refunds from Australia (~$3.7 million) and the UK (~$2.7 million). These funds will be reinvested into clinical programs, notably the ongoing Phase 2 Alzheimer’s Disease trial in Australia and Canada.

This non-dilutive funding will enhance recruitment and enrollment efforts, with plans to expand the trial internationally. CFO David Moss emphasized the importance of these rebates for continued collaboration with the FDA on the U.S. trial.

INmune Bio, Inc. (NASDAQ: INMB) has reported promising results from its collaboration with Professor Armando Villalta at UC Irvine, demonstrating that the Dominant-Negative TNF (DN-TNF) biologic significantly reduces muscle damage and promotes regeneration in a mouse model of Duchenne Muscular Dystrophy (DMD). Unlike current therapies that can cause adverse effects, DN-TNF selectively targets soluble TNF, presenting a novel approach to treating DMD and potentially other neuromuscular diseases. The company has formed a subsidiary to pursue DMD-specific development and is seeking partners for clinical advancement. Future publications and studies are planned to further evaluate this therapeutic.

INmune Bio has announced a grant from the Department of Defense for research into how traumatic brain injury (TBI) leads to Alzheimer’s disease. Collaborating with Virginia Commonwealth University and Barrow Neurological Institute, this project will study the effects of XPro1595 on TBI-induced AD pathology. Key researchers aim to uncover the role of soluble TNF in neuroinflammation and cognitive impairment post-TBI. The findings could pave the way for effective therapies for those with a high risk of AD.

INmune Bio (NASDAQ: INMB) will present data on INKmune™ therapy for patients with MDS or AML at the American Society for Hematology Conference in New Orleans, from December 10-13. The study, conducted at Southampton University, shows INKmune's safety in 4 patients and indicates sustained NK cell activation in 3. Notably, one patient exhibited long-lasting tumor-killing memory-like NK cells. The trial continues to enroll participants in the UK and EU, with plans to expand to the US for solid tumor indications. Key cytokines associated with immune responses were significantly altered post-treatment.

On December 6, 2022, INmune Bio presented findings at the 45th San Antonio Breast Cancer Symposium, highlighting the combination of INB03™ and trastuzumab-deruxtecan for treating HER2+ breast cancer. This combination could reverse resistance to HER2-targeted therapies, enhancing treatment efficacy and reducing toxicity. MUC4, a biomarker of resistance, is downregulated by INB03™, which improves anti-tumor immune responses. Key results showed significant tumor growth inhibition when INB03™ was included, with no added toxicity. This may lead to further immunotherapy opportunities for patients resistant to existing treatments.

INmune Bio will participate in the 15th CTAD Conference from November 29 to December 2 in San Francisco. The company is focused on developing therapies targeting Alzheimer's Disease (AD) through an innovative Phase 2 program using novel biomarkers and strategic trial design. Their XPro™ treatment aims to halt the progression of AD by utilizing unique patient criteria, cutting-edge neuroimaging technologies, and an effective cognitive endpoint called EMACC. INmune believes that their approach will surpass traditional anti-amyloid therapies.

INmune Bio has received a "No Objection Letter" from Health Canada to commence its Phase II trial using XPro1595 for mild Alzheimer’s Disease. This approval enables patient enrollment in Canada, joining ongoing efforts in Australia and awaiting clearance from the FDA for U.S. participation. The first patient has finished dosing and is enrolled in an extension study. XPro1595 works by inhibiting soluble tumor necrosis factor, potentially reducing neuroinflammation and improving cognition in patients.

INmune Bio reported its Q3 2022 financial results, showing a net loss of approximately $7.7 million, down from $9.5 million in Q3 2021. R&D expenses decreased to $5.2 million from $6.5 million year-over-year. The FDA is reviewing a clinical hold on XPro1595 trials for Alzheimer’s Disease, while patient enrollment for the Phase 2 trial is ongoing in Australia. Positive data was shared regarding the INKmune platform's efficacy against solid tumors. The company holds approximately $57.4 million in cash as of September 30, 2022, with 17.9 million shares outstanding.

INmune Bio (NASDAQ: INMB) announced it will host a conference call on November 2, 2022, at 4:30 PM ET to discuss its third-quarter results for the period ended September 30, 2022. The call will provide important updates on the company’s clinical-stage immunology treatments, which focus on harnessing the innate immune system to combat diseases. Notable products, INB03™ and XPro™, are under clinical trials targeting cancer and neurodegenerative diseases. Investors can join via a [live audio webcast](https://www.globenewswire.com/Tracker?data=jni87MnRMi1SJ_fIn5KPNuQg5GFixjb5sEr92-ts9gQK1hhT6EDFSgA5BW2IybxjB_Tm96tsj81J07gj9mqa9mt5ZJ8XnV4lpwJxNdPaMwjg_Mwg2krbA9nimtaw6G69hAyfAcvTnGgZvtVR28TJ4vntC84o5VjjX1he2ny1ornTKsLLXqYj5RBDX9RwiILUPZ5r9UnWt1Ab2gBWySFf1nxecypEkzIeqBqTe7zjRUU=).