Humacyte Q2 2024 Financial Results and Business Update

Humacyte, Inc., a clinical-stage biotechnology company based in Durham, N.C., has recently shared its financial outcomes for the second quarter ending June 30, 2024, alongside significant corporate and clinical achievements. The company is renowned for developing bioengineered human tissues, particularly its acellular tissue engineered vessel (ATEV™), which could revolutionize treatment for various vascular conditions.

CEO Laura Niklason disclosed that the FDA requires additional time to complete its review of the Biologics License Application (BLA) for ATEV™ intended to treat vascular trauma. Despite the extension, Niklason remains optimistic about the product's approvability, pointing out its Priority Review status and the extensive communication and inspections conducted by the FDA. The Priority Review was originally expected to take six months, with an initial PDUFA action date set for August 10, 2024.

In other significant news, Humacyte announced positive results from its Phase 3 clinical trial (V007) of ATEV™ used for hemodialysis access in patients with end-stage renal disease. The study, which included 242 patients, demonstrated that ATEV™ had superior functional patency compared to the current standard of care, an autogenous fistula, at six and twelve months. Patients using ATEV™ also had a longer duration of hemodialysis within the first year. Detailed results of this study are expected to be presented at upcoming medical conferences.

Furthermore, the ATEV™ received its third Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for advanced peripheral artery disease (PAD). This designation highlights the FDA's recognition of ATEV™ as a promising therapeutic option for patients facing severe PAD and potential limb amputation. The previous RMAT designations were for vascular trauma repair and AV access in hemodialysis.

Humacyte's research has also been supported by recent publications and presentations. In June 2024, the Journal of Vascular Surgery published a study by Dr. Todd Rasmussen from the Mayo Clinic, showing favorable outcomes for ATEV™ in patients with chronic limb ischemia, a severe form of PAD. The study indicated that ATEV™ had comparable patency and limb salvage rates to patients using their own veins for arterial bypass.

Additionally, Humacyte presented promising data in June 2024 from preclinical studies at the Breakthrough T1D Beta Cell Consortium Meeting and the American Diabetes Association annual meeting. These studies showcased the potential of their BioVascular Pancreas (BVP™) product for treating type 1 diabetes. In these studies, islets derived from stem cells successfully restored normal blood sugar levels in diabetic mice and survived in non-human primate recipients, supporting insulin production.

In the coronary artery bypass graft (CABG) sector, Humacyte's preclinical trials in non-human primates showed ATEV™ remodeled to match the native coronary vessels' diameter. These findings were presented at the Tissue Engineering and Regenerative Medicine (TERM-2024) Conference, demonstrating ATEV’s potential adaptability and effectiveness for future human clinical trials.

Corporate developments included the appointment of Dr. John P. Bamforth and Dr. Keith Anthony (Tony) Jones to the Board of Directors, bringing their extensive expertise in pharmaceuticals and health systems to the company.

Financially, Humacyte reported no revenue for the second quarter of 2024, consistent with the same period in 2023. Research and development expenses rose to $23.8 million from $20.5 million, driven by increased materials and personnel costs. General and administrative expenses slightly decreased from $6.2 million to $5.7 million. The net loss for the quarter increased significantly to $56.7 million from $22.7 million, primarily due to the remeasurement of contingent earnout liabilities and operating expense increases. The company's cash and cash equivalents stood at $93.6 million as of June 30, 2024.

Humacyte remains committed to advancing its ATEV™ platform across multiple indications, with ongoing clinical trials and regulatory reviews aimed at bringing these transformative treatments to market. The company's perseverance in overcoming regulatory hurdles and achieving clinical milestones underscores its potential to significantly impact patient care and the future of vascular therapies.