Keystone Bio is advancing novel therapeutics and companion diagnostic to shut down a primary driver of systemic inflammation, the root cause of many neurodegenerative and vascular diseases affecting hundreds of millions of people. Keystone Bio is raising a Series B to take advantage of a well mapped out path for a unique therapeutic targeting a known cause for a large group of individuals with Alzheimer’s disease. Keystone Bio wishes to raise awareness of this exciting new area of Alzheimer’s disease and reach out to additional participants for our Series B round. The recent GAIN Trial has validated Pg as a target in Alzheimer’s Dz. Most importantly, it also demonstrated was a marked improvement in patients with mild to moderate cognitive decline by lowering the level of Pg in the mouths of those with active Pg infections in their mouth. Addressing novel mechanisms and effective therapeutic treatments for cognitive decline and Alzheimer’s Disease is a major public health need. Keystone Bio has identified the bacteria Porphyromonas gingivalis (Pg) and the release of specific numerous toxic proteins from its residence in the oral cavity that are recognized as the primary driver of systemic/neuro-vascular inflammation and neuro-degenerative disease leading to cognitive decline and dementias/Alzheimer’s disease (Nara et. al 2021). A recent landmark finding was reported in a sub-cohort analysis from a Phase 2/3 GAIN trial (n=238) demonstrated that lowering the load of Pg in the mouth leads to a significant improvement of cognitive slowing at both 24 and 48 weeks in participants with mild to moderate AD. Another study showed lowering the load of Pg in the mouth had a favorable effect on AD-related brain atrophy (https://doi.org/10.1002/alz.12378). Keystone Bio’s lead therapeutic has been shown to eliminate Pg in the mouth. In addition, as seen in other disease states, the elimination of Pg shows the benefit of decreasing inflammation in the microenvironment of the brain. This also suggests that removing Pg to improve tissue integrity could also become a key component of future treatment approaches, potentially bringing their benefit to later stage patients too. Our lead monoclonal antibody has been shown to prevent recolonization of virulent Porphyromonas gingivalis (Pg) at its source, stopping the daily flow of its highly virulent and disease-causing toxins throughout the body. Our team of entrepreneurs and scientists, including the world’s experts in Pg, Alzheimer’s disease, cardio-metabolic disease, and dentistry is working to stop disease at its source. Virulent Pg is a chronic oral pathogen that sheds toxins that travel through the bloodstream, triggering chronic inflammatory pathways leading to end organ disease. Keystone Bio has made significant advances for our lead therapeutic, ready for pre-clinical tox studies and Phase 1 study. Keystone Bio has developed and continues to advance a strong IP portfolio and a unique product pipeline that includes therapeutics, companion diagnostics and eventual vaccine.

NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently re-filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. NRx is also the parent company of HOPE Therapeutics, Inc., a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. More information is available on the company’s website (www.hopetherapeutics.com).