Humacyte, Inc.

Previous wording

Unless the context indicates otherwise, references in this Quarterly Report to the “Company,” “Humacyte,” “we,” “us,” “our” and similar terms refer to Humacyte, Inc. (formerly known as Alpha Healthcare Acquisition Corp.) and its consolidated subsidiaries (Humacyte Global, Inc. and Humacyte Europe Limited) following the Merger (defined below).

Current wording

Unless the context indicates otherwise, references in this Quarterly Report to the “Company,” “Humacyte,” “we,” “us,” “our” and similar terms refer to Humacyte, Inc. and its consolidated subsidiaries (Humacyte Global, Inc. and Humacyte Europe Limited).

Previous wording

We are a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product. We are pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. We believe our regenerative medicine technology has the potential to overcome limitations in existing standards of care and address the lack of significant innovation in products that support tissue repair, reconstruction and replacement. We are leveraging our novel, scalable technology platform to develop proprietary bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas.

Current wording

We are a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product. We believe our regenerative medicine technology has the potential to overcome limitations in existing standards of care and address the lack of significant innovation in products that support tissue repair, reconstruction and replacement. We are leveraging our novel, scalable technology platform to develop proprietary bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas.

Previous wording

In April 2023, we announced completion of enrollment of our V007 Phase 3 trial of the ATEV for use in AV access for hemodialysis. In July 2024, we announced positive topline results from our V007 Phase 3 trial, where the ATEV met the primary endpoints in the study. Dependent upon interim results from our ongoing V012 Phase 3 trial in women, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.

Current wording

In April 2023, we announced completion of enrollment of our V007 Phase 3 trial of the ATEV for use in AV access for hemodialysis. In July 2024, we announced positive topline results from our V007 Phase 3 trial, where the ATEV met the primary endpoints in the study. If the interim results from our ongoing V012 Phase 3 trial in women are positive, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.

Previous wording

We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $684.5 million and $686.0 million, respectively, and working capital of $30.6 million and $27.9 million, respectively. Our operating losses were approximately $29.7 million and $52.9 million for the three and six months ended June 30, 2025, respectively, and $29.5 million and $56.1 million for the three and six months ended June 30, 2024, respectively.

Current wording

We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively, and working capital of $15.8 million and $27.9 million, respectively. Our operating losses were approximately $24.4 million and $77.3 million for the three and nine months ended September 30, 2025, respectively, and $30.2 million and $86.3 million for the three and nine months ended September 30, 2024, respectively.

Previous wording

Net cash flows used in operating activities were $55.0 million and $48.6 million during the six months ended June 30, 2025 and 2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations. We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future as we begin to commercialize Symvess and advance our product candidates.

Current wording

Net cash flows used in operating activities were $78.9 million and $71.5 million during the nine months ended September 30, 2025 and 2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations. We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future as we begin to commercialize Symvess and advance our product candidates.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $38.0 million and restricted cash of $50.4 million. We believe our cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement will be sufficient to fund operations for at least 12 months from the date of this Quarterly Report. See Note 1 — Organization and Description of Business in the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $19.5 million and restricted cash of $0.4 million. We believe our cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement will be sufficient to fund operations for at least 12 months from the date of this Quarterly Report. See Note 1 — Organization and Description of Business in the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.

Previous wording

We have inventory for which the production costs were recorded as an expense in 2024 prior to FDA approval. We expect cost of goods sold to normalize after utilization of this inventory. If market acceptance of Symvess does not occur at all or on a timely basis prior to the inventory shelf-life expiration, we may be required to write-off some or all inventory, which could affect our financial requirements and financial results. Cost of goods sold includes overhead related to unused production capacity, which was recorded as an expense during the three and six months ended June 30, 2025, as well as royalties expense based on our product revenue.

Current wording

We have inventory for which the production costs were recorded as an expense in 2024 prior to FDA approval. We expect cost of goods sold to normalize after utilization of this inventory. If market acceptance of Symvess does not occur at all or on a timely basis prior to the inventory shelf-life expiration, we may be required to write-off some or all inventory, which could affect our financial requirements and financial results. Cost of goods sold includes overhead related to unused production capacity, which was recorded as an expense during the three and nine months ended September 30, 2025, as well as royalties expense based on our product revenue.

Previous wording

Total revenue was $0.3 million for the three months ended June 30, 2025, compared to no revenue for the three months ended June 30, 2024. Revenue for the three months ended June 30, 2025 consisted of $0.1 million of product revenue from sales of Symvess in the United States and $0.2 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.

Current wording

Total revenue was $0.8 million for the three months ended September 30, 2025, compared to no revenue for the three months ended September 30, 2024. Revenue for the three months ended September 30, 2025 consisted of $0.7 million of product revenue from sales of Symvess in the United States and $0.1 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.

Previous wording

Cost of goods sold was $0.2 million for the three months ended June 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the three months ended June 30, 2024.

Current wording

Cost of goods sold was $0.3 million for the three months ended September 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the three months ended September 30, 2024.

Previous wording

Research and development expenses were $22.0 million for the three months ended June 30, 2025, representing a decrease of $1.7 million, or 7%, from $23.8 million for the three months ended June 30, 2024. The decrease was driven by a $2.0 million decrease in other research and development expense related to the capitalization of overhead costs associated with the commercial manufacturing of Symvess, a $0.9 million decrease in external services and an $0.8 million decrease in clinical trials expense, partially offset by a $1.8 million increase in materials and supplies expense driven by an increase in manufacturing production runs.

Current wording

Research and development expenses were $17.3 million for the three months ended September 30, 2025, representing a decrease of $5.7 million, or 25%, from $22.9 million for the three months ended September 30, 2024. The decrease was driven by a $3.0 million decrease in other research and development expense and $1.0 million decrease in payroll and personnel expenses related to the capitalization of overhead costs associated with the commercial manufacturing of Symvess, a $0.3 million decrease in external services, a $0.5 million decrease in clinical trials expense, and a $0.5 million decrease in materials and supplies expense.

Previous wording

Selling, general and administrative expenses were $7.8 million and $5.7 million for the three months ended June 30, 2025 and 2024, respectively. The increase in selling, general and administrative expenses compared to the prior period of $2.1 million, or 36%, was primarily driven by the commercial launch of Symvess and included a $1.9 million increase in payroll and personnel expenses.

Current wording

Selling, general and administrative expenses were $7.6 million and $7.3 million for the three months ended September 30, 2025 and 2024, respectively. The increase in selling, general and administrative expenses compared to the prior period of $0.3 million, or 4% , was primarily driven by the commercial launch of Symvess, and included a $0.8 million increase in payroll and personnel expenses and $0.3 million increase in professional fees, partially offset by a $1.0 million decrease in external services and consulting expenses.

Previous wording

Total other income, net was $54.4 million for the six months ended June 30, 2025, compared to net expense of $32.5 million for the six months ended June 30, 2024. The increase in net income of $86.9 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily resulted from a $74.4 million increase in the non-cash gain resulting from the remeasurement of the Contingent Earnout Liability during each period.

Current wording

Total other income, net was $6.9 million for the three months ended September 30, 2025 compared to total other expense, net of $9.0 million for the three months ended September 30, 2024. The increase in net income of $15.8 million was primarily attributable to a $13.4 million non-cash gain from the fair value remeasurement of the Contingent Earnout Liability and a $3.0 million non-cash gain from the fair value remeasurement of the derivative liabilities.

Previous wording

Total revenue was $0.8 million for the six months ended June 30, 2025, compared to no revenue for the six months ended June 30, 2024. Revenue for the six months ended June 30, 2025 consisted of $0.2 million of product revenue from sales of Symvess in the United States and $0.6 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.

Current wording

Total revenue was $1.6 million for the nine months ended September 30, 2025, compared to no revenue for the nine months ended September 30, 2024. Revenue for the nine months ended September 30, 2025 consisted of $0.9 million of product revenue from sales of Symvess in the United States and $0.6 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.

Previous wording

Cost of goods sold was $0.4 million for the six months ended June 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the six months ended June 30, 2024.

Current wording

Cost of goods sold was $0.6 million for the nine months ended September 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the nine months ended September 30, 2024.

Previous wording

Research and development expenses were $37.4 million for the six months ended June 30, 2025, representing a decrease of $7.6 million, or 17%, from $45.0 million for the six months ended June 30, 2024. The decrease was primarily driven by a $3.6 million decrease in materials and supplies expense, primarily related to the capitalization of expenditures for inventory during the six months ended June 30, 2025 due to the commencement of commercial manufacturing to support the market launch of Symvess, a $2.4 million decrease in other research and development expenses related to the capitalization of overhead costs associated with the commercial manufacturing of Symvess and a $1.5 million decrease in clinical trials expense.

Current wording

Research and development expenses were $54.7 million for the nine months ended September 30, 2025, representing a decrease of $13.2 million, or 19%, from $67.9 million for the nine months ended September 30, 2024. The decrease was primarily driven by a $4.2 million decrease in materials and supplies expense, related to the capitalization of expenditures for inventory during the nine months ended September 30, 2025 following the commencement of commercial manufacturing to support the market launch of Symvess, a $2.0 million decrease in clinical trials expense, and a $5.4 million decrease in other research and development expenses related primarily to the capitalization of overhead costs associated with the commercial manufacturing of Symvess.

Previous wording

Selling, general and administrative expenses were $15.9 million and $11.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase in general and administrative expenses compared to the prior period of $4.9 million, or 44%, was primarily driven by the commercial launch of Symvess. Significant increases in expenses included a $4.1 million increase in payroll and personnel expenses and a $0.5 million increase in professional fees.

Current wording

Selling, general and administrative expenses were $23.6 million and $18.4 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in general and administrative expenses compared to the prior period of $5.2 million, or 28%, was primarily driven by the commercial launch of Symvess. Significant increases in expenses included a $4.9 million increase in payroll and personnel expenses.

Previous wording

We have historically financed our operations primarily through the sale of equity securities and convertible debt, including pursuant to the 2024 Public Offering, 2025 Public Offering, October 2024 Registered Direct Offering, November Registered Direct Offering, proceeds from the PIPE Financing that occurred in connection with the Merger, borrowings under loan facilities, the Purchase Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $684.5 million and $686.0 million, respectively.

Current wording

We have historically financed our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, the Purchase Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively.

Previous wording

As of June 30, 2025 and December 31, 2024, we had working capital of $30.6 million and $27.9 million, respectively. As of June 30, 2025 and December 31, 2024, we had cash and cash equivalents of $38.0 million and $44.9 million, respectively, and restricted cash of $50.4 million. We funded the restricted cash account on August 14, 2024, in accordance with our amended Purchase Agreement, of which $50.0 million is not subject to our unilateral control.

Current wording

As of September 30, 2025 and December 31, 2024, we had working capital of $15.8 million and $27.9 million, respectively. As of September 30, 2025 and December 31, 2024, we had cash and cash equivalents of $19.5 million and $44.9 million, respectively, and restricted cash of $0.4 million and $50.4 million, respectively. We funded the restricted cash account on August 14, 2024, in accordance with our amended Purchase Agreement, of which $50.0 million was not subject to our unilateral control. In connection with the Purchase Agreement Amendment, the Company made the Purchase Agreement Amendment Payment of $50.0 million, funded from the restricted cash previously maintained for the benefit of the Agent. As a result of the Purchase Agreement Amendment Payment, the Company is no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent unless the Purchase Agreement has not been repaid in full by December 31, 2025, at which point the Company will be required to maintain $12.5 million in such account.

Previous wording

As of June 30, 2025, we had $47.5 million in remaining availability for sales of Common Stock under our Common Stock Purchase Agreement with Lincoln Park and $69.3 million in remaining availability for sales of Common Stock under our ATM Facility. Subsequent to June 30, 2025, we completed sales ofshares under the ATM Facility that provided net proceeds of approximately$6.4 million.

Current wording

As of September 30, 2025, we had $47.5 million in remaining availability for sales of Common Stock under our Common Stock Purchase Agreement with Lincoln Park and $62.7 million in remaining availability for sales of Common Stock under our ATM Facility.

Previous wording

On September 1, 2022, we entered into the ATM Facility for the sale from time to time of up to $80.0 million of shares of Common Stock. As of June 30, 2025, we have sold an aggregate of 2,633,466 shares of Common Stock under the ATM Facility at an average price of $4.08 per share for net proceeds of approximately $10.4 million after deducting sales commissions of approximately $0.3 million. As of June 30, 2025, we had $69.3 million in remaining availability for sales of Common Stock under the ATM Facility. From June 30, 2025 through August 8, 2025, the Company sold an aggregate of 2,492,410 shares of Common Stock under the ATM Facility at an average price of $2.64 for net proceeds of approximately $6.4 million, after deducting sales commissions of approximately $0.2 million.

Current wording

On September 1, 2022, we entered into the ATM Facility for the sale from time to time of up to $80.0 million of shares of Common Stock. As of September 30, 2025, we have sold an aggregate of 5,125,876 shares of Common Stock under the ATM Facility at an average price of $3.38 per share for net proceeds of approximately $16.8 million after deducting sales commissions of approximately $0.5 million. As of September 30, 2025, we had $62.7 million in remaining availability for sales of Common Stock under the ATM Facility.

Previous wording

As of June 30, 2025, we had non-cancellable purchase commitments of $24.3 million for supplies and services that are primarily for research and development. We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at June 30, 2025. For additional information regarding our agreement with Fresenius Medical Care, see Note 12 — Related Party Transactions to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report. For additional information regarding our agreements with Duke University, Yale University and JDRF, see Note 11 — Commitments and Contingencies to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.

Current wording

As of September 30, 2025, we had non-cancellable purchase commitments of $24.2 million for supplies and services that are primarily for research and development. We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at September 30, 2025. For additional information regarding our agreement with Fresenius Medical Care, see Note 13 — Related Party Transactions to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report. For additional information regarding our agreements with Duke University, Yale University and JDRF, see Note 12 — Commitments and Contingencies to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.

Previous wording

On May 12, 2023, we entered into the Purchase Agreement with the Purchasers and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing in respect to the further development and commercialization of our ATEV, to repay our then outstanding credit facility with SVB, and for other general corporate purposes. Pursuant to the Purchase Agreement and subject to customary closing conditions, the Purchasers have purchased certain revenue interests from us in exchange for an aggregate investment amount of up to $150.0 million. Under the terms of the Purchase Agreement, $40.0 million of the Investment Amount, less certain transaction expenses, was funded on May 12, 2023, which was used to repay in full and retire our indebtedness under the our loan agreement with SVB, with the remaining proceeds funded to the Company. On March 11, 2024, $20.0 million of the Investment Amount was funded to the Company. On December 19, 2024, the FDA granted full approval for our BLA for the vascular trauma indication, and we elected not to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we are not entitled to draw on any further installments under the Purchase Agreement. See Note 7 — Revenue Interest Purchase Agreement to the condensed consolidated financial statements for additional details about this financing transaction.

Current wording

On May 12, 2023, we entered into the Purchase Agreement with the Purchasers and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing in respect to the further development and commercialization of our ATEV, to repay our then outstanding credit facility with SVB, and for other general corporate purposes. Pursuant to the Purchase Agreement and subject to customary closing conditions, the Purchasers have purchased certain revenue interests from us in exchange for an aggregate investment amount of up to $150.0 million. Under the terms of the Purchase Agreement, $40.0 million of the Investment Amount, less certain transaction expenses, was funded on May 12, 2023, which was used to repay in full and retire our indebtedness under our loan agreement with SVB, with the remaining proceeds funded to the Company. On March 11, 2024, $20.0 million of the Investment Amount was funded to the Company. On December 19, 2024, the FDA granted full approval for our BLA for the vascular trauma indication, and we elected not to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we are not entitled to draw on any further installments under the Purchase Agreement. See Note 7 — Revenue Interest Purchase Agreement to the condensed consolidated financial statements for additional details about this financing transaction.

Previous wording

On May 12, 2023, we entered into the Purchase Agreement and repaid in full all of the then-existing obligations under our loan agreement with SVB. Under the Purchase Agreement, as of June 30, 2025, we had$68.5 million recorded as a revenue interest liability on our condensed consolidated financial statements. For additional information regarding repayment, see Note 7 — Revenue Interest Purchase Agreement to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.

Current wording

On September 17, 2025, we entered into the Purchase Agreement Amendment with the Purchasers and the Agent to amend the Purchase Agreement. In connection with the Purchase Agreement Amendment, we made a $50 million repayment under the Purchase Agreement, funded from the restricted cash maintained for the benefit of the Agent. Additionally, pursuant to the Purchase Agreement Amendment, we are no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent unless the Purchase Agreement has not been repaid in full by December 31, 2025, at which point we will be required to maintain $12.5 million in such account. Under the Purchase Agreement, as of September 30, 2025, we had $20.7 million recorded as a revenue interest liability on our condensed consolidated financial statements. For additional information regarding the Purchase Agreement, see Note 7 — Revenue Interest Purchase Agreement to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.

Previous wording

The increase in net cash used in operating activities fromthe six months ended June 30, 2024 tothe six months ended June 30, 2025 was primarily due to increased spending on preclinical, clinical and commercial activities as well as payroll and personnel expenses, expansion of clinical development of the ATEV for use in AV access, and our commercial launch of Symvess.

Current wording

The increase in net cash used in operating activities from thenine months ended September 30, 2024 tothe nine months ended September 30, 2025 was primarily due to increased spending on preclinical, clinical and commercial activities as well as payroll and personnel expenses, expansion of clinical development of the ATEV for use in AV access, and our commercial launch of Symvess.

Previous wording

Net cash used in investing activities forthe six months ended June 30, 2025 and June 30, 2024 consisted of purchases of property and equipment.

Current wording

Net cash used in investing activities forthe nine months ended September 30, 2025 and September 30, 2024 consisted of purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of $46.7 million of net proceeds from our 2025 Public Offering. Net cash provided by financing activities for the six months ended June 30, 2024 consisted primarily of $43.0 million of net proceeds from our 2024 Public Offering and $19.5 million of proceeds from the Purchase Agreement.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of $46.7 million of net proceeds from our 2025 Public Offering and $9.8 million of net proceeds from the issuance of stock under our ATM Facility, partially offset by a $50.0 million payment on the revenue interest liability in connection with the Purchase Agreement Amendment. Net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of $43.0 million of net proceeds from our 2024 Public Offering and $19.5 million of proceeds from the Purchase Agreement.