Humacyte(HUMA) - 2023 Q3 - Quarterly Report

PART I – FINANCIAL INFORMATION Financial Statements Presents Humacyte's unaudited condensed consolidated financial statements, including balance sheets, income statements, and cash flows, with notes on accounting policies and financing events Condensed Consolidated Balance Sheet Highlights (unaudited) | ($ in thousands) | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $99,986 | $149,772 | | Total current assets | $102,851 | $154,208 | | Total assets | $149,385 | $204,302 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $15,137 | $19,580 | | Contingent Earnout Liability | $39,601 | $27,893 | | Revenue interest liability | $37,286 | $— | | Total liabilities | $112,392 | $87,374 | | Total stockholders' equity | $36,993 | $116,928 | Condensed Consolidated Statements of Operations Highlights (unaudited) | ($ in thousands, except per share data) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Grant revenue | $— | $1,565 | | Research and development | $56,370 | $48,303 | | General and administrative | $17,495 | $17,050 | | Loss from operations | $(73,865) | $(63,788) | | Change in fair value of Contingent Earnout Liability | $(11,708) | $58,649 | | Net loss | $(85,670) | $(8,245) | | Net loss per share, basic and diluted | $(0.83) | $(0.08) | Condensed Consolidated Statements of Cash Flows Highlights (unaudited) | ($ in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(54,251) | $(52,170) | | Net cash used in investing activities | $(23) | $(367) | | Net cash provided by (used in) financing activities | $4,842 | $(1,234) | | Net decrease in cash, cash equivalents and restricted cash | $(49,432) | $(53,771) | - The company has generated no product revenue since inception and has a history of operating losses, with an accumulated deficit of $512.2 million as of September 30, 2023. Management believes current cash and cash equivalents of $100.0 million are sufficient to fund operations for at least 12 months from the report's issuance date[29][30] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Humacyte's financial performance, liquidity, and business outlook, highlighting clinical trial progress and increased R&D expenses - Humacyte is a clinical-stage company developing bioengineered human tissues (HAVs) for vascular repair, AV access for hemodialysis, and PAD. The company announced positive top-line results from its V005 Phase 2/3 trial in vascular trauma and plans to file a BLA with the FDA in the fourth quarter of 2023[167][169] Comparison of Operating Results (Nine Months Ended Sep 30) | ($ in thousands) | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $56,370 | $48,303 | +17% | | General and administrative | $17,495 | $17,050 | +3% | | Loss from operations | $(73,865) | $(63,788) | +16% | | Net loss | $(85,670) | $(8,245) | +939% | - The significant increase in net loss for the nine months ended September 30, 2023, was primarily driven by a non-cash expense of $11.7 million from the remeasurement of the Contingent Earnout Liability, compared to a non-cash gain of $58.6 million in the same period of 2022, representing a negative swing of $70.3 million[193] - Research and development expenses for the nine months ended Sep 30, 2023 increased by $8.1 million (17%) to $56.4 million, driven by a $4.8 million increase in payroll and a $2.4 million increase in external services to support clinical trials and BLA filing preparations[191] - As of September 30, 2023, the company had $100.0 million in cash and cash equivalents, which is believed to be sufficient to fund operations for at least the next 12 months. In May 2023, the company secured a Revenue Interest Purchase Agreement for up to $150.0 million in financing, receiving an initial $40.0 million[195][196] Quantitative and Qualitative Disclosures About Market Risk Humacyte, as a smaller reporting company, is exempt from providing quantitative and qualitative disclosures about market risk - The company qualifies as a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[219] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting - Based on an evaluation as of September 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[221] - No changes in internal control over financial reporting occurred during the three months ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[222] PART II – OTHER INFORMATION Legal Proceedings The company is not aware of any legal proceedings or claims expected to materially adversely affect its business or financial condition - The Company is not aware of any legal proceedings or claims that are expected to have a material adverse effect on its business or financials[224] Risk Factors No material changes to previously disclosed risk factors have occurred, except as updated in the Q2 2023 Form 10-Q - No material changes from the risk factors discussed in the Annual Report have occurred, except as noted in the Q2 2023 Form 10-Q[225] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds during the period Other Information The company reported no other information for this item Exhibits This section lists exhibits filed with the Quarterly Report, including CEO and CFO certifications and Inline XBRL financial data