INmune Bio Inc. (NASDAQ: INMB)

INmune Bio Inc. (NASDAQ: INMB) is a diversified clinical-stage immunology company developing novel therapies that target distinct parts of a patient's innate immune system to fight disease. Drug candidates INKmune™ and INB03 may be used to treat cancer while XPro1595 targets neuroinflammation as a cause of Alzheimer's disease. INmune Bio's product platforms utilize a precision therapy approach to promote the body's innate immune response to treat unsolved problems in medicine.

INmune Bio is the first biotechnology company to close an initial public offering (IPO) in 2019 and commence trading on The Nasdaq Capital Market. The company also received a "Part the Cloud" award from the Alzheimer's Association in 2018 which included a $1 million grant to advance INmune Bio's XPro1595 drug candidate.

INmune Bio's product pipeline targets three segments of concern:

• Alzheimer's disease/dementia claims 5.5 million patients in the United States. INmune Bio views Alzheimer's as an immunologic disease which changes the drug discovery process, changes the way clinical trials are designed, and may provide hope for patients and caregivers.
• Cancer residual disease which is expected to generate more than 1.7 million new cases yearly with an estimated 609,640 fatalities. INMB believe that converting resting Natural Killer ("NK") cells to primed NK cells, which kill cancerous cells on contact, is an important therapeutic strategy to help clear residual disease.
• Resistance to immunotherapy. By preventing the proliferation and function of cells that resist immunotherapy, patients should have a stronger immune response to cancer cells and may respond better to other cancer treatments including immunotherapy and live longer.

INmune Bio Drug Candidates and Clinical Programs

INKmune is a biologic delivery system that primes a patient's resting NK cells to kill cancer. INKmune targets residual disease for patients that have completed initial cancer therapy (surgery, radiation and/or chemotherapy) and have a low burden of disease with a high risk of relapse.

In late 2019, INKmune will start enrolling patients in a phase I/II trial for women with relapsed refractory ovarian cancer. In many patients, cancer relapse after seemingly effective cancer therapy is due to a failure of the patients own NK cells to eliminate minimal residual disease ("MRD").

Using a novel mechanism of action and a precision medicine approach, INKmune therapy should enhance NK cells' ability to eliminate residual disease.

INB03 is a checkpoint inhibitor that targets myeloid derived suppressor cells ("MDSC") which can produce an immunosuppressive shield that prevents a patient's own immune system from attacking the cancer. INmune Bio is currently completing a monotherapy INB03 phase I trial in patients with advanced solid tumors. The INB03 program will transition into a combination therapy clinical program in the summer of 2019 to prepare for a phase II trial in patients resistant to checkpoint inhibitors due to increased MDSC.

Treatment with INB03 should eliminate MDSC in the tumor microenvironment to allow checkpoint inhibitors to be therapeutically effective.

XPro1595 targets the microglial immune cells of the brain that are activated in many Alzheimer's disease patients. These microglial cells are a cause of neuroinflammation that can kill nerve cells and promote synaptic dysfunction – the cause of dementia in Alzheimer's.

The three-month, phase I trial is expected to enroll 18 patients in summer of 2019. It is designed to measure traditional and novel biomarkers of inflammation in patients with mild to moderate Alzheimer's disease who have neuroinflammation. The trial is supported by a $1 million "Part the Cloud" grant from the Alzheimer's Association. Inflammation, especially chronic inflammation, is being recognized as an important part of the pathology of many diseases including cancer and Alzheimer's disease.

Management

Dr. RJ Tesi, M.D., INmune Bio co-founder, CEO and acting chief medical officer, has been a licensed physician since 1982 and a Fellow of the American College of Surgery since 1991. He received his medical degree from Washington University School of Medicine in 1982 and has served many roles in several development-stage biotech companies focused on treatment of neurodegenerative diseases, hematologic malignancies, and other inflammatory diseases.

CFO David J. Moss co-founder, has been with the company since its formation in September 2015. He holds an MBA from Rice University and a bachelor's degree in economics from the University of California, San Diego. Moss has founded, funded and taken public various companies in a variety of industries since 1995.

Mark Lowdell, Ph.D. co-founder, has served as the chief scientific officer and chief manufacturing officer at INmune Bio since the company's formation. He is a professor of cell and tissue therapy at University College London where he has led a translational immunotherapy group since 1994. He has also been a director of cellular therapy at the Royal Free London NHS Foundation Trust. He received his Ph.D. in clinical immunology from London Hospital Medical College, University of London in 1992 and is a qualified immunopathologist.

Christopher J. Barnum is director of neuroscience at INmune Bio. Barnum is a neuroimmunologist with broad expertise across neurodegenerative and psychiatric diseases holding multiple positions in academic and industry. His focus has been on translating inflammatory therapies into clinical treatments for neurologic diseases using a biomarker-directed approach. Barnum's research has been supported by the NIH, the Michael J. Fox Foundation, and the Alzheimer's Association. He received his Ph.D. in neuroscience from Binghamton University.