INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in Europe

Rhea-AI Summary

INmune Bio, Inc. (NASDAQ: INMB) has received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer’s disease in Poland, with additional EU countries expected to open soon. The company also received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive.

Positive

• Regulatory approval for extending the Phase II trial in Poland and expected expansion to other EU countries demonstrate the company's commitment to advancing treatments for early Alzheimer's disease. The receipt of a $2.8M USD cash refund provides non-dilutive funding to reinvest in clinical programs.

Negative

• None.

The Company received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer’s disease in Poland, with additional European Union (EU) countries expected to open soon.

The Company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive.

Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to  advancing treatments that leverage the patient’s innate immune system to combat disease, has received acceptance of a Clinical Trial Application (CTA) under EU Clinical Trials Regulation to initiate a Phase II trial in Early Alzheimer’s Disease (AD) with XPro™ in Poland. Additional regulatory approval for the Phase II AD clinical trial is expected from at least two to potentially six more EU countries in the upcoming months.  The EU approval is part of the Company’s international clinical development strategy for XPro™ in patients with early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom.

The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation. In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro™ demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a “virtual biopsy” of the brain, treatment with XPro™ demonstrated improvements in the structural integrity of both gray and white matter in the brain.

“We are delighted with the addition of clinical sites in the EU. Countries were selected based on their previous experience in Alzheimer’s disease research and their interest in novel therapies,” said RJ Tesi M.D., CEO of INmune Bio. “Broadening the clinical presence in the EU serves dual purposes.  First, it addresses the near-term objective of completing enrollment of the Phase II trial.  Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial.”

The Company also recently received a cash refund of approximately $2.8 million pursuant to a research and development tax incentive from Australia. The Company will use the rebate to reinvest in its clinical programs.

"We are delighted with the ongoing receipt of R&D rebates from research-friendly jurisdictions like Australia. These funds provide a non-dilutive funding source, allowing INmune to reinvest in expanding recruitment and enrollment not only in Australia and Canada but also in our newer locations in the U.K. and the EU," remarked David Moss, Chief Financial Officer.

About XPro™

XPro™ (XPro1595, pegipanermin) is a next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials 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 potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing neurodegeneration while improving synaptic function and promoting remyelination. 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 biotechnology 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, CFO (858) 964-3720
info@inmunebio.com

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 x-823

FAQ

What is the regulatory approval received by INmune Bio, Inc.?

INmune Bio, Inc. received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer’s disease in Poland, with additional EU countries expected to open soon.

How much cash refund did the company receive and for what purpose?

The company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive, which will be used to reinvest in its clinical programs.