On March 27, 2025 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 year ended December 31, 2024 and provides a business update (Press release, INmune Bio, MAR 27, 2025, View Source [SID1234651524]).
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Full Year 2024 and Recent Corporate Highlights
DN-TNF Platform Highlights (XPro1595, XPro):
● Announced completion of enrollment for its Phase 2 trial on Friday, 27 September, 2024. This global, blinded, randomized Phase 2 trial (the "AD02 trial") is focused on patients with Early Alzheimer’s Disease (AD) and biomarkers of elevated neuroinflammation. Final enrollment of 208 patients exceeded the trial’s target enrollment of 201 patients.
● Completed two separate interim analyses of blinded data from its AD02 trial. The analyses demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between baseline EMACC and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Key findings of the analysis included:
o Statistical Correlation: An independent review confirmed a significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, the key cognitive endpoints in the AD02 trial.
o 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.
o 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.
● Hosted a webinar titled "Why EMACC is the Optimal Tool for Measuring Cognitive Change in Early Alzheimer’s Trials," that explained the development of EMACC and its advantages in assessing cognitive changes over time in early AD patients while also covering the regulatory landscape for Alzheimer’s disease drug development and the role of the CDR-SB clinical scale. The replay can be found here or with this link: View Source
● 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 new phase 1 study data presented at the annual Alzheimer’s Association International Conference on 29 July 2024 demonstrating dose-dependent effect of XPro on Proteins that regulate synapses in Alzheimer’s patients. The new analysis revealed that a 12-week treatment with XPro resulted in a significant change in synaptic proteins, which are essential for communication between neurons.
● Announced statistically significant improvements in electroencephalography (EEG), a biomarker of brain function, in patients with moderate to severe Alzheimer’s Disease treated with XPro for four weeks.
● Demonstrated 24-month stability validation of XPro for phase III readiness and commercial supply chain modeling & announced development of novel immunogenicity assay.
CORDStrom Platform
● Reported results of a double-blinded, randomized, placebo-controlled, cross-over study, known as "MissionEB," investigating CORDStrom for treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients, which evidenced a favorable benefit-risk profile.
● FDA granted CORDStrom a Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for treatment of epidermolysis bullosa (EB).
● Data from the MissionEB trial show that CORDStrom was easily delivered, extremely well tolerated, with no serious adverse events related to CORDStrom reported at either 3-months or 6-months post-treatment across all age and RDEB-severity patient sub-types. In children with severe disease, CORDStrom reduced itch at 3-months and led to a sustained reduction of over 27% at 6-months in some patients. These results demonstrate that a clinically meaningful reduction in itch severity is sustained over time. In children with intermediate disease severity, CORDStrom provided a broader range of improvements, including reduced skin involvement and less pain, as well as a large reduction in itch. In younger children with RDEB (age <10yrs), CORDStrom provided improvements in skin scores, indicating better skin integrity and reduced disease activity. Interviews with subjects and caregivers strongly support the clinical benefits of CORDStrom as both caregivers and patients were able to correctly identify which treatment had been CORDStrom and which had been placebo in this cross-over study.
● The Company plans to initiate a 12-month open label study at GOSH, including all patients enrolled in the MissionEB study, where patients will receive 3 cycles of CORDStrom therapy at 0, 4 and 8 months. Each cycle of CORDStrom is a single infusion of CORDStrom 14 days apart.
INKmune Platform:
● Announced that INKmune demonstrates excellent safety and increased NK-Cell activity in the first dosing cohort, in its 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.
● The CaRe PC trial completed dosing of all patients in the phase I part of the trial and commenced dosing phase II patients at the intermediate and high dose cohorts. Interim analysis of the first three patients treated at the lowest dose was presented at the Innate Killer Summit conference in San Diego earlier this month and reported changes in all biomarkers consistent with NK cell activation in vivo post INKmune treatment which mirrored that seen in patients with AML/MDS treated previously.
● Published landmark paper in Journal Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) senior-authored by Mark Lowdell, PhD, 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 INKmune 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 format 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.
● Safety of INKmune remains excellent. There have been more than 30 administrations of INKmune in the mCRPC study given on an out-patient basis, with no significant drug related adverse events or episodes of cytokine release syndrome (CRS). Combining the experience with INKmune from the MDS/AML and mCRPC trials, over 40 infusions of INKmune have been given safely without the need for conditioning therapy, pre-medication, or cytokine support.
Corporate:
● Completed repayment of outstanding Silicon Valley Bank term loan in December.
● Executed securities purchase agreements with new and existing institutional investors and certain directors, officers and employees of the Company for total gross proceeds of approximately $27.5 million. As part of the offerings, the company issued approximately 3.9 million warrants to purchase common stock. The term of the warrants may be accelerated with positive AD02 data as defined in the warrant agreements, which if exercised for cash will raise approximately $30 million dollars.
● Sold shares of common stock through the ATM program during 2024 for total gross proceeds of approximately $2.4 million. Between January 1, 2025, and March 27, 2025, sold shares of common stock through the ATM program for total gross proceeds of approximately $5.4 million.
● Joined the broad-market Russell 3000 Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of July 1, 2024.
● Received a research and development rebate from Australia in July of approximately $2.5 million USD.
Upcoming Events and Milestones:
● Top line cognitive results and secondary endpoints from the AD02 trial in Alzheimer’s Disease will be available in June 2025.
● Data from the ongoing INKmune trial in mCRPC will be released as they become available. The next data set should be released in Q2 or Q3, 2025.
● A Phase II trial of XPro in patients with Treatment-Resistant Depression will begin enrollment soon once the NIH releases funds for the trial.
● Anticipate filing a BLA in RDEB in 2025 or early 2026 followed by MAA application in the UK and EU. If approved on or prior to September 2026, CORDstrom could be eligible for a Priority Review Voucher.
Financial Results for the Year Ended December 31, 2024:
● Net loss attributable to common stockholders for the year ended December 31, 2024 was approximately $42.1 million, compared to approximately $30.0 million during the year ended December 31, 2023.
● Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, compared to approximately $20.3 million during the year ended December 31, 2023.
● General and administrative expenses were approximately $9.5 million for the year ended December 31, 2024, compared to approximately $9.6 million during the year ended December 31, 2023.
● Other income, net, was approximately $0.6 million for the year ended December 31, 2024, compared to other expense, net, of approximately $0.3 million during the year ended December 31, 2023.
● As of December 31, 2024, the Company had cash and cash equivalents of approximately $20.9 million.
● As of March 27, 2025, the Company had approximately 22.9 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 2024 Year End Conference Call when reaching an operator.
Date: March 27, 2025
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448 or 1-203-518-9708 (international): 1-203-518-9808
Conference ID: INMUNE
A live audio webcast of the call can be accessed by clicking here or using this link: View Source;tp_key=4727e947f4
A transcript will follow approximately 24 hours from the scheduled call. A telephone replay will also be available for approximately 30 days by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11157984.
About XPro
XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About CORDStrom
CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics. The CORDStrom product platform shares many similarities, including reagents, equipment, and procedures, with the Company’s INKmune oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically manufacture both products in a rotational campaign with resource and environmental efficiencies.
Initially developed at the INKmune manufacturing facilities utilizing UK academic grant funding, CORDStrom is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.