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 subsidiary (Humacyte Global, Inc.) following the Merger (defined below); references to “Legacy Humacyte” refer to Humacyte, Inc. prior to the Merger; and references to “AHAC” refer to Alpha Healthcare Acquisition Corp. prior to the Merger.

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. (formerly known as Alpha Healthcare Acquisition Corp.) and its consolidated subsidiaries (Humacyte Global, Inc. and Humacyte Europe Limited) following the Merger (defined below).

Previous wording

For the ATEV, we believe there is substantial clinical demand for safe and effective vascular conduits to replace and repair blood vessels throughout the body. Vascular injuries resulting from trauma are common in civilian and military populations, frequently resulting in the loss of either life or limb. Existing treatment options in the vascular repair, reconstruction and replacement market include the use of autologous vessels and synthetic grafts, which we believe suffer from significant limitations. For example, the use of autologous veins to repair traumatic vascular injuries can lead to significant morbidity associated with the surgical wounds created for vein harvest and prolonged times to restore blood flow to injured limbs, leading to an increased risk of complications such as amputation and reperfusion injury. In addition, in many instances of vascular trauma the patient may not have adequate vein available, or the time between injury and treatment is too long to make autologous graft repair feasible. Synthetic grafts are often contraindicated in the setting of vascular trauma due to wound contamination that contributes to higher infection risk that can lead to prolonged hospitalization and limb loss. Given the competitive advantages our ATEVs are designed to have over existing vascular substitutes, we believe that ATEVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs.

Current wording

For the ATEV, we believe there is substantial clinical demand for safe and effective vascular conduits to replace and repair blood vessels throughout the body. Vascular injuries resulting from trauma are common in civilian and military populations, frequently resulting in the loss of either life or limb. Existing treatment options in the vascular repair, reconstruction and replacement market include the use of autologous vessels and synthetic grafts, which we believe suffer from significant limitations. For example, the use of autologous veins to repair traumatic vascular injuries can lead to significant morbidity associated with the surgical wounds created for vein harvest and prolonged times to restore blood flow to injured limbs, leading to an increased risk of complications such as amputation and reperfusion injury. In addition, in many instances of vascular trauma the patient may not have adequate vein available, or the time between injury and treatment is too long to make autologous graft repair feasible. Synthetic grafts are often contraindicated in the setting of vascular trauma due to wound contamination that contributes to higher infection risk and can lead to prolonged hospitalization and limb loss. Given the competitive advantages our ATEVs are designed to have over existing vascular substitutes, we believe that ATEVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs.

Previous wording

In September 2023, we announced positive topline results from our V005 Phase 2/3 trial in vascular trauma, and in December 2023, we filed a BLA for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and autologous vein use is not feasible. In February 2024, the FDA accepted the BLA filing and granted priority review and set a Prescription Drug User Fee Act date of August 10, 2024. On August 9, 2024, the FDA informed us that it required additional time to complete its review of the BLA for the vascular trauma indication. On December 19, 2024, the FDA granted full approval for Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. In February 2025, the FDA completed its required review of commercial batch information for Symvess and authorized us to commence commercial shipments and we shipped our first commercial products in March 2025.

Current wording

In September 2023, we announced positive topline results from our V005 Phase 2/3 trial in vascular trauma, and in December 2023, we filed a BLA for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and autologous vein use is not feasible. In February 2024, the FDA accepted the BLA filing, granted priority review and set a Prescription Drug User Fee Act date of August 10, 2024. On August 9, 2024, the FDA informed us that it required additional time to complete its review of the BLA for the vascular trauma indication. On December 19, 2024, the FDA granted full approval for Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. In February 2025, the FDA completed its required review of commercial batch information for Symvess and authorized us to commence commercial shipments and we shipped our first commercial products in March 2025.

Previous wording

We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $646.9 million and $686.0 million, respectively, and working capital of $53.7 million and $27.9 million, respectively. Our operating losses were approximately $23.2 million and $26.6 million for the three months ended March 31, 2025 and 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 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.

Previous wording

Net cash flows used in operating activities were $28.6 million and $27.3 million during the three months ended March 31, 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 $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.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $62.8 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 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.

Previous wording

As further disclosed in Note 13— Subsequent Events to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report, on April 28, 2025, we implemented a cost reduction action to reduce our workforce by approximately 31 employees, cease recruitment of an additional planned new hires, and reduce other operating expenses. Employees impacted by this plan were notified on May 7, 2025. We are undertaking these cost reductions to improve cash runway and to better align the Company’s organizational structure with its top business objectives. Humacyte estimates that it will incur savings due to the workforce and other operating cost reductions, and reduced capital expenditures, net of termination severance and benefits, totaling approximately $13.8 million in 2025 and up to approximately $38.0 million in 2026.

Current wording

On April 28, 2025, we implemented a cost reduction action to reduce our workforce by 30 employees, cease recruitment of additional planned new hires, and reduce other operating expenses. Substantially all of the employees impacted by this plan were notified beginning May 7, 2025. We undertook these cost reductions to improve cash runway and to better align the Company’s organizational structure with its top business objectives. We incurred aggregate charges representing one-time cash expenditure for severance and other employee termination benefits of approximately $0.7 million during the second quarter of 2025, of which $0.6 million was recognized in research and development expenses and $0.1 million was recognized in selling, general and administrative expenses on our condensed consolidated statements of operations and comprehensive income (loss). Humacyte estimates that it will incur savings due to the workforce and other operating cost reductions, and reduced capital expenditures, net of termination severance and benefits, totaling approximately $13.8 million in 2025 and up to approximately $38.0 million in 2026.

Previous wording

Prior to our recent commercialization, all of our revenue was derived from government and other grants. From inception through March 31, 2025, we have been awarded grants, including grants from the California Institute of Regenerative Medicine (“CIRM”), the National Institutes of Health (“NIH”), and the Department of Defense, to support our development, production scaling and clinical trials of our product candidates.

Current wording

Prior to the recent commercialization of the ATEVs in the vascular trauma indication, all of our revenue was derived from government and other grants. From inception through June 30, 2025, we have been awarded grants, including grants from the California Institute of Regenerative Medicine (“CIRM”), the National Institutes of Health (“NIH”), and the Department of Defense, to support our development, production scaling and clinical trials of our product candidates.

Previous wording

We may generate revenue in the future from government and other grants, payments from future license or collaboration agreements and from product sales of any of our product candidates that receive marketing approval. We expect that any revenue we generate will fluctuate from quarter to quarter. If we fail to complete the development of, or obtain marketing approval for, our product candidates in a timely manner, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.

Current wording

We may generate revenue in the future from government and other grants, payments from future license or collaboration agreements and from product sales of our ATEVs in the vascular trauma indication and any of our product candidates that receive marketing approval. We expect that any revenue we generate will fluctuate from quarter to quarter. If we fail to complete the development of, or obtain marketing approval for, our product candidates in a timely manner, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.

Previous wording

We have inventory for which the production costs were recorded as an expense in 2024 prior to FDA approval. This inventory is expected to last us approximately the next six months depending upon actual levels of sales, and 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 in the 2025 period.

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 six months ended June 30, 2025, as well as royalties expense based on our product revenue.

Previous wording

The majority of our research and development resources are currently focused on our Phase 2 and 3 clinical trials for our 6 millimeter ATEV and other work needed to obtain marketing approval for our 6 millimeter ATEV for use in AV access in hemodialysis in the United States. We have incurred and expect to continue to incur significant expenses in connection with these and our other clinical development efforts, including expenses related to regulatory filings, trial enrollment and conduct, data analysis, patient follow up and study report generation for our Phase 2 and Phase 3 clinical trials.

Current wording

The majority of our research and development resources are currently focused on our Phase 2 and 3 clinical trials for our 6 millimeter ATEV and other work needed to obtain marketing approval for our 6 millimeter ATEV for use in AV access in hemodialysis and PAD in the United States. We have incurred and expect to continue to incur significant expenses in connection with these and our other clinical development efforts, including expenses related to regulatory filings, trial enrollment and conduct, data analysis, patient follow up and study report generation for our Phase 2 and Phase 3 clinical trials.

Previous wording

Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger, and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents and short-term investments, (iii) interest expense incurred on the Purchase Agreement (defined above) and finance leases, and (iv) the change in fair value of our derivative liabilities and asset including the private placement Common Stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger; Common Stock warrant liabilities related to our Registered Direct Offerings; the contingent derivative liability related to the Purchase Agreement; a liability related to a freestanding option agreement related to the Purchase Agreement; a derivative liability related to our agreement with JDRF; and a derivative asset related to our Common Stock Purchase Agreement, all of which are subject to remeasurement to fair value at each balance sheet date resulting in a non-cash gain or loss.

Current wording

Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger, and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents, (iii) interest expense incurred on the Purchase Agreement (defined above) and finance leases, and (iv) the change in fair value of our derivative liabilities and asset including the private placement Common Stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger; Common Stock warrant liabilities related to our Registered Direct Offerings; the contingent derivative liability related to the Purchase Agreement; a liability related to a freestanding option agreement related to the Purchase Agreement; a derivative liability related to our agreement with JDRF; and a derivative asset related to our Common Stock Purchase Agreement, all of which are subject to remeasurement to fair value at each balance sheet date resulting in a non-cash gain or loss.

Previous wording

There was $0.5 million in total revenue for the three months ended March 31, 2025, compared to no revenue for the three months ended March 31, 2024. Revenue for the three months ended March 31, 2025 consisted of $0.1 million of product revenue from sales of Symvess in the United States and $0.4 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 $0.3 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.

Previous wording

Cost of goods sold was $0.1 million for the three months ended March 31, 2025 and includes overhead related to unused production capacity which was recorded as an expense in the period. There was no cost of goods sold for the three months ended March 31, 2024.

Current 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.

Previous wording

Total other income, net was $62.3 million for the three months ended March 31, 2025 compared to net expense of $5.3 million for the three months ended March 31, 2024. The increase in net income of $67.6 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024 primarily resulted from a $54.3 million increase in the non-cash income resulting from the remeasurement of the Contingent Earnout Liability during each period and a $14.9 million increase in non-cash income resulting from the remeasurement of our derivative liabilities and asset during each period.

Current wording

Total other expense, net was $7.9 million for the three months ended June 30, 2025 compared to net expense of $27.2 million for the three months ended June 30, 2024. The decrease in net expense of $19.2 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024 primarily resulted from a $20.1 million decrease in the non-cash loss resulting from the remeasurement of the Contingent Earnout Liability during each period.

Previous wording

Research and development expenses were $15.4 million for the three months ended March 31, 2025, representing a decrease of $5.8 million, or 27%, from $21.3 million for the three months ended March 31, 2024. The decrease was primarily driven by a $5.5 million decrease in the purchase of materials and supplies expense, primarily related to the capitalization of expenditures for inventory during the three months ended March 31, 2025 due to the commencement of commercial manufacturing to support the market launch of Symvess.

Current 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.

Previous wording

Selling, general and administrative expenses were $8.1 million and $5.3 million for the three months ended March 31, 2025 and 2024, respectively. The increase in selling, general and administrative expenses during this period of $2.8 million, or 53%, was primarily driven by the commercial launch of Symvess. Significant increases in expenses included a $2.2 million increase in payroll and personnel expenses and a $0.3 million increase in professional fees.

Current 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.

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 Merger and related PIPE Financing, 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 March 31, 2025 and December 31, 2024, we had an accumulated deficit of $646.9 million and $686.0 million, respectively.

Current 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.

Previous wording

As of March 31, 2025 and December 31, 2024, we had working capital of $53.7 million and $27.9 million, respectively. As of March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $62.8 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 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.

Previous wording

As of March 31, 2025, we had $47.5 million in remaining availability for sales of Common Stock under our Common Stock Purchase Agreement with Lincoln Park and $72.6 million in remaining availability for sales of Common Stock under our ATM Facility.

Current 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.

Previous wording

As further disclosed in Note 13, on April 28, 2025, we implemented a cost reduction action to reduce our workforce by approximately 31 employees, cease recruitment of additional planned new hires, and reduce other operating expenses. We are undertaking these cost reductions to improve cash runway and to better align the Company’s organizational structure with its top business objectives. Before consideration of management plans if we are unable to raise sufficient capital to fund our operations as described below, we believe our cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement will be sufficient to fund operations at least into June 2026. The future viability of the Company beyond that point is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. See Note 1 — Organization and Description of Business to our accompanying unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding our assessment. We believe that our longer-term working capital, planned research and development, capital expenditures and other general corporate funding requirements may be satisfied through the sale of equity, debt, financings, debt refinancings or restructurings or through potential collaborations with other companies, other strategic transactions or government or other grants. Our liquidity plans are subject to a number of risks and uncertainties, including those described in the sections entitled “Forward-Looking Statements” and “Risk Factors” in this Quarterly Report and our Annual Report. If we are unable to raise sufficient capital, we plan to implement a program that delays, reduces, suspends or ceases certain of our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. Based on our current cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement, and after considering management’s plans, we believe we have the ability to fund operations at least into the second half of 2026.

Current wording

As discussed above, on April 28, 2025, we implemented a cost reduction action to reduce our workforce by 30 employees, cease recruitment of additional planned new hires, and reduce other operating expenses. We undertook these cost reductions to improve cash runway and to better align the Company’s organizational structure with its top business objectives. 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 twelve months from the issuance date of these interim financial statements. The future viability of the Company beyond that point is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. See Note 1 — Organization and Description of Business to our accompanying unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding our assessment. We believe that our longer-term working capital, planned research and development, capital expenditures and other general corporate funding requirements may be satisfied through the sale of equity, debt, financings, debt refinancings or restructurings or through potential collaborations with other companies, other strategic transactions or government or other grants. Our liquidity plans are subject to a number of risks and uncertainties, including those described in the sections entitled “Forward-Looking Statements” and “Risk Factors” in this Quarterly Report and our Annual Report. If we are unable to raise sufficient capital, we may be forced to delay, reduce, suspend or cease certain of our planned research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.

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 did not elect 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 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.

Previous wording

On October 4, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $30.0 million worth of Common Stock and warrants in the October 2024 Registered Direct Offering. The net proceeds to us from the October 2024 Registered Direct Offering were approximately $28.0 million, after deducting placement agent’s fees and offering expenses of approximately $2.0 million. The October 2024 Registered Direct Offering closed on October 7, 2024.

Current wording

On October 4, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $30.0 million of Common Stock and warrants in the October 2024 Registered Direct Offering. The net proceeds to us from the October 2024 Registered Direct Offering were approximately $28.0 million, after deducting placement agent’s fees and offering expenses of approximately $2.0 million. The October 2024 Registered Direct Offering closed on October 7, 2024.

Previous wording

On November 13, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $15.0 million worth of Common Stock and warrants in the November 2024 Registered Direct Offering. The net proceeds to us from the November 2024 Registered Direct Offering were approximately $14.9 million after deducting offering expenses of approximately $0.1 million. The November 2024 Registered Direct Offering closed on November 15, 2024.

Current wording

On November 13, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $15.0 million of Common Stock and warrants in the November 2024 Registered Direct Offering. The net proceeds to us from the November 2024 Registered Direct Offering were approximately $14.9 million after deducting offering expenses of approximately $0.1 million. The November 2024 Registered Direct Offering closed on November 15, 2024.

Previous wording

On September 1, 2022, we entered into an agreement for the sale from time to time up to $80.0 million of shares of Common Stock pursuant to the ATM Facility. As of March 31, 2025, we have sold an aggregate of 1,409,389 shares of Common Stock under the ATM Facility at an average price of $5.25 per share for net proceeds of approximately $7.2 million after deducting sales commissions of approximately $0.2 million. As of March 31, 2025, we had remaining availability for sales of Common Stock under the ATM Facility of $72.6 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 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.

Previous wording

As of March 31, 2025, we had non-cancellable purchase commitments of $32.7 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 March 31, 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 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.

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 March 31, 2025, we had$66.4 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 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.

Previous wording

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) commercialize Symvess and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in AV access for hemodialysis, (iii) advance our pipeline in major markets, including PAD Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and BVP for diabetes, and (iv) scale out our manufacturing facility as required to satisfy market demand. We will need additional funding in connection with these activities.

Current wording

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) commercialize Symvess and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in AV access for hemodialysis, (iii) advance our pipeline in major markets, including PAD Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and BVP for diabetes, and (iv) expand our manufacturing facility as required to satisfy market demand. We will need additional funding in connection with these activities.

Previous wording

The increase in net cash used in operating activities fromthe three months ended March 31, 2024 tothe three months ended March 31, 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 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.

Previous wording

Net cash used in investing activities forthe three months ended March 31, 2025 and March 31, 2024 consisted of purchases of property and equipment.

Current 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 consisted primarily of $47.0 million of net proceeds from our 2025 Public Offering. Net cash provided by financing activities for the three months ended March 31, 2024 consisted primarily of $43.4 million of net proceeds from our 2024 Public Offering and $20.0 million of proceeds from the Purchase Agreement.

Current 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.

Previous wording

Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K under the Exchange Act (“Regulation S-K”). Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company if (1) the market value of Common Stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of its second fiscal quarter are less than $100 million and the market value of Common Stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.

Current wording

Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K under the Exchange Act (“Regulation S-K”), and may continue to qualify as such even after we no longer qualify as an emerging growth company. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company if (1) the market value of Common Stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of its second fiscal quarter are less than $100 million and the market value of Common Stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.