On November 1, 2024 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, reported its financial results for the quarter ended September 30, 2024 and provides a business update (Press release, INmune Bio, NOV 1, 2024, View Source [SID1234647636]).

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Q3 2024 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● Announced completion enrollment for its Phase 2 Alzheimer’s Disease ("AD") trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the "AD02 trial") is focused on patients with Early AD and biomarkers of elevated neuroinflammation. Enrollment of new patients into the trial was concluded after the Company determined that there are sufficient patients currently in screening to meet the trial’s target of 201 patients. All patients currently in the screening process will remain eligible to participate in AD02, which will likely result in modest over-enrollment.

● Announced that results of interim analysis of blinded data from its AD02 trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), an accepted endpoint for AD trials. Key findings of the analysis included:

● Statistical Correlation: An independent review confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, the secondary endpoint in the AD02 trial. CDR-SB is the clinical rating scale most used in AD registration studies.

● Reliability: The correlation of EMACC when measured during the screening process and again at the first study visit before treatment was found to be 0.93. Higher precision produces results that are more robust and replicable with smaller sample sizes.

● Differentiation Capability: The difference in EMACC performance between patients with CDR global ratings of 0.5 (prodromal AD) and those rated 1.0 (mild dementia) was very large, with an effect size (Cohen’s d) of 0.87 (p<.0001). This demonstrates EMACC’s ability to accurately differentiate between disease stages, highlighting its sensitivity and precision.

● Announced publication in Cell Reports, "Microglia Regulate Cortical Remyelination via ΤNFR1-Dependent Phenotypic Polarization." Myelin is necessary for fast and efficient communication between neurons. Loss of myelin compromises neuron function and communication and is a key step in the neurodegenerative process of many CNS diseases, including Alzheimer’s Disease. Data from the publication identifies soluble TNF as a critical cytokine checkpoint that converts microglia from a reparative, remyelinating cell to a damaging, demyelinating cell. These data suggest that blocking soluble TNF is a promising strategy for treating demyelinating diseases.

● Announced Webinar on Cognitive Testing using EMACC and CSD-SB to be held on November 7, 2024, at 1PM ET. Click Here to Register

INKmune Platform:

● Announced that INKmune demonstrates excellent safety and increased NK-Cell activity in first dosing cohort, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic Castration-Resistant Prostate Cancer (mCRPC). Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK cell activity and function.

● There have been 21 administrations of INKmune in the mCRPC study given on an out-patient basis, with no significant adverse events including zero cases of cytokine release syndrome (CRS). Combining the experience with INKmune from the MDS/AML and mCRPC trials, over 30 infusions of INKmune have been given safely without the need for conditioning therapy, pre-medication, or cytokine support.

● The CaRe PC trial has recently dosed the first patient in the highest dose cohort and opened the phase II enrolment for subjects in the intermediate dose group. The dose of INKmune in the intermediate and high dose cohorts is 3 and 5 times the dose of INKmune in the first cohort. All eight clinical sites are now open and additional results from the trial will be released from the higher dose cohorts as they become available.

● Published landmark paper in Journal Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) led by Mark Lowdell, PhD, INmune’s Chief Scientific Officer, titled, Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmuneTM priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers further supporting INKmune’s in vivo treatment methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and solid tumors.

● Announced new formulation of INKmune that supports highest trial dose with single bag administration and expansion of bioreactor capacity in preparation of scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA that also includes additional validation data supporting an alternative critical reagent used in INKmune manufacturing, improving supply chain redundancy.

Corporate:

● Executed securities purchase agreements with new and existing institutional investors and certain directors and officers and employees of the Company for gross proceeds of approximately $13.0 million.

● Added to the broad-market Russell 3000 Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of Monday, July 1st, 2024.

● Received a $2.5 million research and development rebate from Australia in July.

Upcoming Events and Milestones:

● Top-line data from the Phase 2 Alzheimer’s trial is expected in the second quarter of 2025.

● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression 2H 2024.

● Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial by year-end. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available.

Financial Results for the Third Quarter Ended September 30, 2024:

● Net loss attributable to common stockholders for the quarter ended September 30, 2024 was approximately $12.1 million, compared to approximately $8.6 million during the quarter ended September 30, 2023.

● Research and development expenses totaled approximately $10.1 million for the quarter ended September 30, 2024, compared to approximately $6.0 million during the quarter ended September 30, 2023.

● General and administrative expenses were approximately $2.2 million for the quarter ended September 30, 2024, compared to approximately $2.6 million during the quarter ended September 30, 2023.

● As of September 30, 2024, the Company had cash and cash equivalents of approximately $33.6 million.

● As of October 31, 2024, the Company had approximately 22.2 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.

Date: October 31, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): 1-203-518-9843
Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link: INmune Bio, Inc. Third Quarter 2024 Earnings Call – 1692115

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11156467.