Humacyte(HUMA) - 2023 Q4 - Annual Results

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update Humacyte's 2023 financial results reflect increased operating expenses and a widened net loss, while early 2024 saw significant cash bolstering Business Update and Corporate Highlights Humacyte achieved significant regulatory milestones in late 2023 and early 2024, highlighted by the FDA's acceptance and Priority Review of its Biologics License Application (BLA) for the Human Acellular Vessel (HAV) in vascular trauma Clinical and Regulatory Updates The FDA accepted Humacyte's BLA for the HAV in vascular trauma, granting it Priority Review with a PDUFA action date of August 10, 2024 - The FDA accepted the Biologics License Application (BLA) for the Human Acellular Vessel (HAV) for use in urgent arterial repair following extremity vascular trauma[1][4] - The BLA was granted Priority Review, setting a Prescription Drug User Fee Act (PDUFA) action date for August 10, 2024, which shortens the review time from ten to six months[1][5] - The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial and real-world evidence from wartime injuries in Ukraine, which showed higher rates of blood flow (patency) and lower rates of amputation and infection compared to historic synthetic graft benchmarks[4] - The HAV has received multiple FDA designations for the vascular trauma indication, including Regenerative Medicine Advanced Therapy (RMAT) and a priority designation from the Secretary of Defense, underscoring its potential to address a critical need[5] Presentations and Publications The company presented positive results from its V005 vascular trauma trial at the VEITH Symposium, and a preclinical study on small-diameter HAV for congenital heart conditions was published - Positive results from the V005 vascular trauma trial were presented at the VEITH Symposium, highlighting higher patency and lower amputation/infection rates for the HAV compared to historical benchmarks[6] - A preclinical study published in a peer-reviewed journal showed the potential of the 3.5mm small-diameter HAV to treat tetralogy of Fallot, a congenital heart defect, with the vessels remaining patent for up to six months and showing evidence of host cell repopulation[6] Fourth Quarter and Full Year 2023 Financial Highlights Humacyte ended 2023 with $80.4 million in cash, which was further bolstered by approximately $63.1 million in early 2024 from a public offering and an additional funding draw - The company ended 2023 with $80.4 million in cash and cash equivalents, a position strengthened in early 2024 by raising approximately $43.1 million in net proceeds from a public offering and receiving $20 million from a funding arrangement with Oberland Capital[1][8] - Management believes its current cash position is adequate to finance operations for at least 12 months, extending well past the anticipated FDA PDUFA date in August 2024[8] Financial Performance (Statement of Operations) For the full year 2023, Humacyte reported no revenue, with increased operating expenses and a significant net loss of $110.8 million primarily due to a non-cash charge Financial Performance (Statement of Operations) | Financial Metric | Q4 2023 ($) | Q4 2022 ($) | FY 2023 ($) | FY 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Grant Revenue | $0 | $0 | $0 | $1.6M | | R&D Expenses | $20.2M | $15.0M | $76.6M | $63.3M | | G&A Expenses | $6.0M | $5.8M | $23.5M | $22.9M | | Loss from Operations | ($26.2M) | ($20.8M) | ($100.0M) | ($84.6M) | | Net Loss | ($25.1M) | ($3.7M) | ($110.8M) | ($12.0M) | | Net Loss Per Share | ($0.24) | ($0.04) | ($1.07) | ($0.12) | - The increase in R&D expenses in 2023 was primarily due to higher costs for personnel, external services, and materials supporting expanded R&D initiatives, clinical trials for vascular trauma (V005, V017), and the BLA filing[10] - The significant increase in net loss for FY 2023 was mainly driven by the non-cash remeasurement of the contingent earnout liability, which resulted in a $10.7 million net expense, compared to a $72.6 million net income in the prior year[10] Financial Position (Balance Sheet) As of December 31, 2023, Humacyte reported total assets of $128.2 million, a decrease from 2022, with total liabilities increasing to $114.7 million and stockholders' equity significantly decreasing Financial Position (Balance Sheet) | Balance Sheet Item | Dec 31, 2023 ($) | Dec 31, 2022 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $80.4M | $149.8M | | Total current assets | $83.3M | $154.2M | | Total assets | $128.2M | $204.3M | | Liabilities & Equity | | | | Total current liabilities | $18.4M | $19.6M | | Total liabilities | $114.7M | $87.4M | | Total stockholders' equity | $13.5M | $116.9M | | Total liabilities and stockholders' equity | $128.2M | $204.3M | - The decrease in cash and cash equivalents from $149.8 million in 2022 to $80.4 million in 2023 reflects the company's net cash usage of $69.0 million for the year to fund operations[8][17]