INmune Bio Inc. Announces New Phase 1 Study Data Demonstrating Dose-Dependent Effect of XPro™ on Proteins that Regulation Synapses in Alzheimer’s Patients

AAIC Poster Presentation Highlights XPro’s™ Significant Effects on a Wide Range of Synaptic Proteins and Pathways

BOCA RATON, Fla., July 29, 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 is pleased to be presenting results of a new and advanced proteomic analysis at this year’s annual Alzheimer’s Association International Conference (AAIC) in Philadelphia, PA. The poster summarizes dose-related changes in the cerebrospinal fluid (CSF) proteome in patients with Alzheimer’s disease (AD) treated with XPro^TM in the company’s phase 1b study.

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.

“The loss of synapses begins early in Alzheimer’s disease and has devastating consequences as the disease progresses,” stated CJ Barnum, PhD, VP of Neuroscience at INmune Bio. “The robust effect of XPro^TM on a broad number of proteins and pathways that regulate the formation of synapses is consistent with what we have observed in preclinical models and what we expect to happen when normal/healthy immune function is restored.”

The formation and elimination of synapses is executed by cells of the innate immune system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment. Restoring synapses requires a normally functioning innate immune system.

“We are encouraged by this new evidence of a treatment effect at the cellular level in proteins known to be affected by AD pathologies,” said Company CEO RJ Tesi, MD. “XPro’s direct impact on synaptic proteins provides further support to the improvement in synaptic function we recently observed with EEG data and provides further evidence that we are having a significant effect on restoring the immune system. This is yet another biological precursor to what we believe will result in a cognitive benefit which we are currently testing in our ongoing Phase 2 trial.”

INmune Bio is currently running a phase 2 clinical trial in mild to moderate Alzheimer’s patients. Top-line results from that trial are expected in early 2025.

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 without immunosuppression. 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 INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation and immunology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

Forward-Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:
David Moss
Chief Financial Officer
(858) 964-3720

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com