Inmune Bio Inc - INMB STOCK NEWS

INmune Bio Inc. (NASDAQ: INMB) has completed enrollment for its Phase 2 trial in Early Alzheimer's Disease (AD). The global, blinded, randomized trial, known as AD02, focuses on patients with Early AD and biomarkers of elevated neuroinflammation. The company closed enrollment on September 27, 2024, after determining that ongoing screenings would meet the target of 201 patients. Patients currently in the screening process remain eligible, potentially leading to modest over-enrollment.

CJ Barnum PhD, VP of CNS Drug Development and AD02 trial leader, emphasized the significance of this milestone for INmune Bio, its partners, and trial participants. He noted that exceeding the 201-patient goal will enhance the trial's statistical power, expressing anticipation for the final study results.

INmune Bio Inc. (NASDAQ: INMB) has announced initial results from the first patient cohort in its Phase I/II trial of INKmune™, a Natural Killer (NK) cell therapy for metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial, named CaRe PC, has shown excellent safety profile with all patients receiving treatment as out-patients without pre-medication. Even at the lowest dose, there is clear evidence of persistent immunologic effects.

Key findings include:

• Changes in phenotype and function of patients' NK cells
• Increase in circulating activated NK cells in 2 of 3 patients
• Increased NK cell function sustained for over 40 days after final infusion in all patients
• One patient showed a transient 21% decrease in PSA associated with increased NK cell activity

The second dosing cohort has completed, and the third cohort is expected to begin in about 30 days, with doses 3 and 5 times higher than the first cohort, respectively.

INmune Bio Inc. (NASDAQ: INMB) announced results from an additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease trial. The analysis showed exceptional performance of the novel cognitive measure EMACC and a highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Key findings include:

1. A highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB.
2. High reliability of EMACC with a correlation of 0.93 between screening and first study visit.
3. EMACC's ability to differentiate between disease stages with an effect size of 0.87 (p<.0001).

The company believes these results validate their trial design and endpoint selection, potentially de-risking their clinical program compared to traditional AD drug development approaches.

INmune Bio Inc. (Nasdaq: INMB) has announced a $13.0 million registered direct offering of common stock and warrants. The company will sell 2,341,260 shares of common stock and warrants to purchase an additional 2,341,260 shares. The combined purchase price is $5.50 per share and warrant for institutional investors and $6.50 for company insiders. Warrants will be exercisable after six months at $6.40 per share with a five-year expiration. The offering is expected to close around September 16, 2024. Proceeds will be used for working capital and general corporate purposes. A.G.P./Alliance Global Partners is acting as the sole placement agent for this offering, which is made pursuant to an effective shelf registration statement.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, has announced its participation in the Baird 2024 Global Healthcare Conference in New York, NY. The company's management will present on Tuesday, September 10, 2024, from 8:30-9:00 AM Eastern Time in Session III, Empire Ballroom B, Mezzanine Level.

INmune Bio focuses on developing treatments that harness a patient's innate immune system to fight disease. This conference presentation provides an opportunity for the company to showcase its progress and engage with investors in the healthcare sector. The Baird Global Healthcare Conference is a significant event that brings together industry leaders and investors to discuss advancements in healthcare.

INmune Bio Inc. (NASDAQ: INMB) announced Q2 2024 results and provided a business update. Key highlights include:

1. The Phase 2 trial for XPro™ in Early Alzheimer's Disease is on track to complete enrollment by Q3 end.
2. A new Phase 1b analysis shows XPro's™ significant effects on synaptic proteins.
3. INKmune™ platform progress includes a new formulation and completion of the first cohort in the Phase I/II trial for metastatic castration-resistant prostate cancer.
4. The company raised $14.5 million in equity capital.
5. Q2 2024 financial results: Net loss of $9.7 million, R&D expenses of $7.1 million, and cash position of $31.1 million as of June 30, 2024.

INmune Bio (NASDAQ: INMB) presented new Phase 1 study data at the Alzheimer's Association International Conference, demonstrating XPro's™ dose-dependent effect on synaptic proteins in Alzheimer's patients. The 12-week treatment resulted in significant changes to proteins essential for neuron communication. This aligns with preclinical models and supports the restoration of normal immune function.

The company's VP of Neuroscience, CJ Barnum, emphasized the importance of these findings, as synaptic loss is an early and devastating consequence of Alzheimer's. CEO RJ Tesi highlighted that this cellular-level evidence supports recent EEG data showing improved synaptic function. INmune Bio is currently conducting a Phase 2 trial for mild to moderate Alzheimer's, with top-line results expected in early 2025.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage immunology company, has announced its upcoming second quarter 2024 financial results and corporate update conference call. The event is scheduled for Thursday, August 1, 2024, at 4:30 PM EDT. Investors and interested parties can participate via phone or live audio webcast. The call will cover results for the quarter ended June 30, 2024, and provide insights into the company's current operations and future plans. A replay of the call will be available until August 8, 2024, and a transcript will be provided approximately 24 hours after the scheduled call.

INmune Bio Inc. (NASDAQ: INMB) has published a landmark paper in the Journal for ImmunoTherapy of Cancer, detailing the biology of their Natural Killer cancer immunotherapy, INKmune™. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune™ priming, show increased cytotoxicity against multiple tumor types. Notably, mlNK cells from cancer patients are as potent as those from healthy volunteers, supporting INKmune's in vivo treatment approach.

The research provides insights into NK cell memory mechanisms, potentially leading to innovative treatments for hematological malignancies and solid tumors. INKmune™ priming increases proteins that protect NK cells in the tumor microenvironment, which is promising for their ongoing clinical trial in metastatic castration-resistant prostate cancer. The study also demonstrates in vivo generation of mlNK cells and their enhanced metabolic function, suggesting improved performance in the tumor microenvironment.