SAN DIEGO, CA (June 14, 2017) Hillhurst Biopharmaceuticals, Inc., a biopharmaceutical company focused on developing therapies to augment the cytoprotective heme oxygenase metabolic pathway, today announced the award of a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of approximately $1.5 MM to fund further pre-clinical development of Hillhurst’s lead candidate, HBI-002, an oral therapeutic for the prevention of delayed graft function experienced by kidney transplant patients. The heme oxygenase pathway is thought to regulate inflammatory processes and apoptosis (cell death) and to promote tissue repair. Moreover, other formulations of the drug substance of HBI-002 have been demonstrated to prevent delayed graft function in preclinical studies. The Company anticipates entering IND-enabling studies within the next year. Hillhurst is collaborating on this project with Leo Otterbein, Ph.D., Associate Professor of Surgery at Harvard Medical School and a staff scientist at Beth Israel Deaconess Medical Center, whose lab will test HBI-002 in in vivo kidney transplant models.

“With this award, the NIDDK recognizes the therapeutic potential of HBI-002 to address this important medical need for patients undergoing kidney transplantation,” said Andrew Gomperts, Hillhurst’s Chief Executive Officer. “Hillhurst is grateful to the NIDDK for recognizing the value of advancing the development of HBI-002. We believe our novel approach of targeting the heme oxygenase pathway with an oral therapeutic holds great promise, which we believe is validated by this award.”

Kidney transplantation is a critical, life-saving procedure for patients with end stage renal disease that involves a surgical operation in which a person receives a kidney from another person. Delayed Graft Function (DGF), where a transplanted kidney does not function as expected after surgery, is a major challenge in kidney transplantation, with an incidence rate as high as 55% in certain patient groups. DGF substantially increases the challenges associated with post-transplant management, leading to inferior short- and long-term graft (transplanted kidney) survival and patient survival, longer hospital stays, and higher costs. Despite these factors, there is a dearth of approved therapies for DGF.

About HBI-002
Hillhurst’s lead product, HBI-002, is a proprietary investigational drug product designed to augment the protective cellular heme oxygenase metabolic pathway to limit tissue inflammation and injury. HBI-002 is an orally dosed therapeutic enabling acute and chronic use for patients suffering from conditions associated with inflammation and cell death, such as kidney transplantation, sickle cell disease, and acute cerebral injury, among others.

About Hillhurst
Hillhurst is a biopharmaceutical company focused on leveraging the heme oxygenase system to develop therapeutics with cytoprotective properties. Building on more than fifty years of research into the heme oxygenase enzyme and its metabolites as therapeutics, Hillhurst has developed HBI-002 to enable the oral delivery of the gasotransmitter carbon monoxide (CO) that Hillhurst employs to augment the heme oxygenase pathway to treat conditions associated with inflammation, cell death and oxidative tissue injury. Dr. Otterbein is a consultant for Hillhurst and has received stock options as compensation for his consulting services.

To learn more about Hillhurst, please visit www.hillhurstbio.com.

Media Contact:   Andrew Gomperts   President and CEO   hillhurstpress@hillhurstbio.com