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INmune Bio, Inc. to Provide Additional Manufacturing Information to FDA as Part of IND Application for XPro1595 in Alzheimer's Disease

Key Takeaway: INmune Bio, Inc. to Provide Additional Manufacturing Information to FDA as Part of IND Application for XPro1595 in Alzheimer's Disease BOCA RATON, FL., May 23, 2022 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused

Full Press Release Details

INmune Bio, Inc. to Provide Additional Manufacturing Information to
FDA as Part of IND Application for XPro1595 in Alzheimer's Disease
BOCA RATON, FL., May 23, 2022 (GLOBE NEWSWIRE) -- INmune Bio,
Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness
the patient's innate immune system to fight disease, today announced that on May 20, 2022, the Company was informed via e-mail communication
from the U.S. Food and Drug Administration (FDA) requesting additional information around Chemistry Manufacturing and Controls (CMC) of
the newly manufactured XPro1595 (XPro ). As part of the communication, the Agency placed the Company's Investigational
New Drug (IND) application to initiate its Phase 2 clinical trial of XPro in patients with Alzheimer's Disease (AD) in the
U.S. on clinical hold. The FDA indicated they will provide an official clinical hold letter to INmune in approximately 30 days.
INmune plans to provide additional updates pending discussion with the FDA. The Phase 2 trial of XPro remains open in Australia
and continues to enroll patients.
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
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 ), Mild Alzheimer's disease,
Mild Cognitive Impairment 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, 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.
David Moss, CFO (858) 964-3720
Investor Contact: Jason Nelson
(516) 842-9614 x-823
Last updated: May 23, 2022