The Venture Codex

Participated · Series B · Oct 2015

Humacyte is a Durham, N.C.-based clinical-stage biotechnology platform developing and manufacturing acellular human tissues, including Human Acellular Vessels (HAVs). Its HAV portfolio is in late-stage clinical trials targeting arteriovenous access for hemodialysis, vascular trauma repair, and peripheral arterial disease. The company is also pursuing preclinical programs in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and other cell and tissue applications. Humacyte intends to use recent financing to strengthen financial and operational flexibility as it advances its pipeline and prepares for near-term Phase 3 data readouts. Leadership has stated an objective to prepare the company to become publicly traded. The company announced a definitive business combination agreement with Alpha Healthcare Acquisition Corp. alongside a fully committed $175 million PIPE financing agreement. Humacyte develops technology to grow stable, off-the-shelf investigational human tissue replacements for use in regenerative medicine and vascular and non-vascular surgery. Its lead product, human acellular vessels (HAV), is intended to reduce inflammation and clotting, elicit a low immune response and potentially lower healthcare costs by reducing surgical interventions. The company is running a Phase 2 vascular trauma trial to study HAV for traumatic vascular injuries. In October 2017 Humacyte received a $3.4M contract from the U.S. Department of Defense to fund that trial, and in September 2017 it was awarded $14.1M from the California Institute for Regenerative Medicine to expand clinical applications of HAV. The company filed with the SEC disclosing a $75M equity raise from 29 investors and did not disclose planned use of the proceeds. Humacyte is led by chairman and CEO Carrie Cox, who joined the company in 2010 and previously served as EVP and then president of Global Pharmaceuticals. Humacyte develops HUMACYL (Human Acellular Vessel/HAV) using a proprietary platform to engineer human extracellular matrix–based tissues that can be shaped into tubes, sheets, or particulates for clinical use. Its lead program is HUMACYL as a vascular access conduit for patients requiring hemodialysis; the company is conducting a pivotal Phase III trial (HUMANITY) comparing HAV to sPTFE grafts and received RMAT designation in March 2017. Humacyte plans broader indications for HUMACYL and is running a new CIRM‑funded study comparing HAV to arteriovenous fistulas in ESRD patients who are candidates for fistulas. The company will monitor evaluable subjects for 24 months in the new study and aims to show HUMACYL is a durable, safe alternative to synthetic grafts and fistulas. Humacyte also investigates HAV for lower extremity arterial bypass in peripheral arterial disease and continues to advance future pipeline products for vascular repair and replacement. Humacyte develops human extracellular matrix–based tissues, including an investigational human acellular vessel (HAV) called HUMACYL, intended to provide vascular access for End Stage Renal Disease patients who require hemodialysis. The company’s platform engineers off-the-shelf tissue products that can be shaped into tubes, sheets, or particulate conformations with properties similar to native tissues. HUMACYL has received FDA Fast Track designation for vascular access and is in ongoing Phase II trials in the U.S. and EU; the company plans to initiate a global Phase III study in the coming months. Humacyte says implanted HAVs have the potential to resemble patients’ own blood vessels and to last longer with fewer complications than current synthetic products. The recent financing will fund the upcoming global Phase III trials and support development of future pipeline products for vascular and non-vascular indications such as coronary artery bypass, trachea and esophagus replacement, and peripheral arterial disease bypass. The company was founded in 2004 and is based in Research Triangle Park, N.C. Humacyte develops a proprietary platform to engineer human tissues that can be formed into tubes, sheets or other shapes to treat vascular diseases and repair the body. The company was founded by Dr. Laura Niklason in late 2004 and is based in Durham, North Carolina. Its lead work centers on creating artificial blood vessels suitable for transplantation into patients such as those with kidney failure. Humacyte is transitioning from development toward commercialization and recently appointed Carrie Cox as CEO to lead that effort. Financially, the company disclosed a $12 million investment via a debt offering from a single investor in an amended SEC filing and previously raised about $7 million in debt about a year earlier. The founder indicated the company has taken in funds from its existing investors to support ongoing work.