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Ischemix, Inc. Receives US Department of Defense Funding of $2.9 million to Conduct Phase 1 Study of Drug Candidate to Treat Traumatic Brain Injury (TBI)

July 7, 2021

Novel, proprietary drug candidate has shown therapeutic potential in extensive preclinical studies

GRAFTON, MA - Ischemix, Inc., a private company focused on developing therapeutics for serious medical conditions, today announced that the US Department of Defense has made a $2.9 award to the Company to fund a Phase 1 study of CMX-2043, a novel compound for the treatment of acute TBI. This competitive award was granted by US Army Medical Research and Development Command (USAMRDC), Combat Casualty Care Research Program (CCCRP) in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium. The award will pay for a substantial portion of the costs manufacturing and formulating additional supply of the drug candidate as well as the costs of performing the trial. DoD/MTEC previously awarded $1.9 million to Ischemix to fund preclinical research on CMX-2043 for TBI.

CMX-2043, a multi-modal cytoprotective compound based on a naturally-occurring molecule present in the human body, has previously demonstrated safety and efficacy in preclinical models of TBI. The successful preclinical efficacy results were achieved in measures of recognized blood biomarkers, MRI analysis and behavior.

“We are pleased to have received this second award from DoD/MTEC for the development of our novel compound for treating TBI” said Geoffrey E. Clark, Chairman and Chief Medical Officer of Ischemix. “This compound aims to improve the health outcomes of TBI patients in military and civilian populations, thereby increasing patients’ quality of life and reducing the economic and social costs to society.”

“We have assembled a highly experienced team of partners in drug manufacturing and formulation and in clinical trial management to work with us on this Phase 1 trial” said David DeWahl, President and CEO of the Company. “We are excited to commence this important phase of the development of our proprietary drug candidate to treat TBI.”

About the Phase 1 trial

The Phase 1 trial will be a seamless single ascending dose (SAD)/ multiple ascending dose (MAD) study to evaluate the safety of CMX-2043 in healthy volunteers. The SAD will have five sequential dose groups with eight patients per group and the MAD will have four sequential dose groups with 10 patients per group. This work will progress CM-2043 from technology readiness level (TRL) 5 to TRL6.

About TBI

TBI is a condition for which there are currently no approved pharmaceutical therapies available. The Center for Disease Control reports that in the US in 2014, there were about 2.9 million TBI-related emergency department visits. It is estimated that each year TBI is responsible for 60,000 deaths and causes 80,000 individuals to have permanent disabilities. It is estimated that the annual direct and indirect cost of TBI in the US are approx. $77 billion. The US DoD reported 434,681 TBIs among its worldwide service members in the period 2000 – 2020 and 16,198 TBIs in 2020.

About CMX-2043

CMX-2043 is a multi-modal, small molecule, cytoprotective compound based on a naturally-occurring molecule present in the human body. CMX-2043 exhibits several mechanistic properties that may act in concert to attenuate the biochemical and cellular perturbations associated with injury in TBI. The drug has compiled a record of safety with no reported serious adverse drug-related events in its use in over 400 patients enrolled in clinical trials. CMX-2043 is the subject of multiple issued composition-of-matter and use patents around the world.

About Ischemix, Inc.

Ischemix is a privately-held drug development company based in Grafton, MA. The Company focuses on developing its family of cytoprotective compounds for serious diseases and conditions. The primary focus of the Company is the development of its lead compound, CMX-2043, for treatment of TBI.

About U.S. Army Medical Research and Development Command

The U.S. Army Medical Research and Development Command is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, and medical, chemical and biological defense.https://mrdc.amedd.army.mil/

About Neurotrauma at Combat Casualty Care Research Program

The Neurotrauma and Traumatic Brain Injury Portfolio is a requirements-based program that seeks to improve the far-forward capabilities of military diagnostic and treatment for the spectrum of TBI severities, with emphasis on moderate and severe TBI and polytrauma under Multi-Domain Operations in prolonged field care scenarios.https://ccc.amedd.army.mil/Portfolios/Pages/NTBI.aspx

About MTEC

MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transactional Agreement with the U.S. Army Medical Research and Development Command. MTEC is managed by Advanced Technology International.To find out more about MTEC, visit mtec-sc.org.

Note: The views expressed in this release are those of Ischemix, Inc. and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.