RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the company raised $75 million in a Series C preferred stock financing, led by a global consortium of existing private investors and new investors, including PointState Capital. The company has received more than $330 million in total funding to date, with more than $290 million in private investments and awards of up to $40 million through federal and state grants and contracts.
The funding is expected to support Humacyte’s ongoing HUMANITY study, the company’s pivotal Phase III study assessing the human acellular vessel (HAV), or HUMACYL®, as a conduit for hemodialysis in patients with end-stage renal disease who are not candidates for fistula placement. In September 2017, Humacyte announced the completion of enrollment of 350 evaluable subjects and expects 12-month post-implantation patient data from the study to be available during the third quarter of this year.
HUMACYL is an investigational product that has not yet been approved by the FDA. However, clinical trials to date suggest that HUMACYL has the potential to become a part of the body’s living tissue. These trials also suggest that HUMACYL may have the potential to last longer with fewer complications than existing synthetic alternatives used for hemodialysis access, possibly lowering healthcare costs by decreasing the number of surgical interventions.
Humacyte also intends to use the funds to complete the development, testing, and qualification of the proprietary bioprocessing system planned to manufacture HUMACYL. Earlier this year, Humacyte completed construction of its state-of-the-art, R&D and bioprocessing facility in Durham, North Carolina. Upon Phase III study completion and facility qualification, the company plans to file a biologics license application (BLA) to seek marketing authorization for HUMACYL. As previously announced, HUMACYL was granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), which is expected to expedite its pathway through the FDA review process.
“The enthusiastic response from new and existing investors is a reflection of the remarkable opportunity Humacyte has to revolutionize vascular medicine, through our groundbreaking biomedical engineering platform,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “Completing the final stage of clinical testing for our first product candidate later this year will be a significant achievement for our organization and the overall regenerative medicine industry.”
The company also announced plans to complete the transition of its development teams and laboratories to the new facility by the third quarter of 2018. The new facility will also serve as Humacyte headquarters.
Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.
All statements, other than statements of historical fact, included in this announcement are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “will”, “anticipate”, “expect”, “believe”, “intend” and “should” or the negative of these terms or other comparable terminology. These statements relate to future events or Humacyte’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Humacyte’s actual results, performance or achievements to be materially different. Except as required by law, Humacyte assumes no obligation to update these forward-looking statements.