Humacyte, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
HUMA$0.59+29.6%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001193125-26-347022
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-455588
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 133 previous paragraphs and 129 current paragraphs.
88 unchanged; 31 reworded; 10 added; 9 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
On July 31, 2026, we received a letter from the staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, for the 30 consecutive business days ended July 30, 2026, the closing bid price of our Common Stock was below the minimum $1.00 per share requirement for continued listing on The Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1). We have been provided an initial period of 180 calendar days, or until January 27, 2027, to regain compliance. See Part II, Item 1A, “Risk Factors,” for additional information.
Current report
On August 26, 2026, all outstanding Public Warrants and Private Placement Warrants assumed in connection with the Merger expired unexercised in accordance with their terms. Prior to the expiration of the Public Warrants, Nasdaq filed a Form 25-NSE with the SEC on August 25, 2026 to delist the Public Warrants from Nasdaq, resulting in the suspension of trading in the Public Warrants. See Note 7, Stockholders’ Equity and Warrants, to our condensed consolidated financial statements for additional information.
Current report
On October 1, 2026, our Common Stock Purchase Agreement with Lincoln Park Capital Fund, LLC expired in accordance with its terms. Through September 30, 2026, we sold 500,000 shares of Common Stock under the Common Stock Purchase Agreement for aggregate gross proceeds of approximately $2.5 million, all of which were sold during the year ended December 31, 2025. We did not sell any shares under the Common Stock Purchase Agreement during the nine months ended September 30, 2026. As of September 30, 2026, $47.5 million of unused purchase capacity remained under the Common Stock Purchase Agreement. The Common Stock Purchase Agreement expired in accordance with its terms on October 1, 2026, and the remaining $47.5 million of purchase capacity expired unused and is no longer available to us as a source of liquidity. In connection with the expiration, we remeasured the related derivative asset to a fair value of zero as of September 30, 2026 and recognized a non-cash loss of $0.7 million within change in fair value of derivatives during the three months ended September 30, 2026. See Note 3, Fair Value Measurements, and Note 7, Stockholders' Equity and Warrants, to our condensed consolidated financial statements, and "Liquidity and Capital Resources—Sources of Liquidity" below for additional information.
Current report
In August 2026, the parties agreed in principle to settle the Securities Litigation, subject to court approval and other customary conditions. On November 2, 2026, the parties entered into a stipulation and agreement of settlement with respect to the Securities Litigation, and the co-lead plaintiffs filed a motion for preliminary approval of the settlement. In September 2026, the parties reached an agreement in principle to resolve the Derivative Actions, subject to court approval and other customary conditions. The parties are in the process of finalizing the settlement documentation with respect to the related Derivative
Current report
Actions. In connection with these matters, we recorded an aggregate litigation settlement liability of $9.8 million and a separate insurance recovery asset of approximately $9.1 million as of September 30, 2026. See Note 10, Commitments and Contingencies, to our condensed consolidated financial statements for additional information.
Current report
General and administrative expenses increased by $1.4 million, or 18%, to $9.0 million for the three months ended September 30, 2026 from $7.6 million for the three months ended September 30, 2025. The increase primarily reflected a $1.0 million increase in professional fees, including litigation-related expenses, net of related insurance recoveries, and a $0.4 million net increase in other general and administrative expenses.
Current report
Total Other Income, Net
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
General and administrative expenses increased by $1.4 million, or 6%, to $25.0 million for the nine months ended September 30, 2026 from $23.6 million for the nine months ended September 30, 2025. The increase was primarily due to higher professional fees, including litigation-related expenses, net of related insurance recoveries, partially offset by net decreases in other general and administrative expenses.
Current report
Total Other Income, Net
Removed paragraphs (9)
Previous report
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 report
In July 2024, we announced positive topline results from our V007 Phase 3 trial of the ATEV for use in AV access, where the ATEV met the primary endpoints in the study. In June 2026, we announced positive interim results from our V012 Phase 3 trial in women, showing that the ATEV achieved superior catheter-free days compared to AV fistula, the primary endpoint in the study. 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 report
On April 21, 2026, we entered into the Third Amendment to our distribution agreement with Fresenius Medical Care. Pursuant to the amendment, we have the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution agreement, as amended) on a worldwide basis. In connection with the reversion of ex-U.S. rights to us, we will pay Fresenius Medical Care low-single-digit royalties on net sales of the Distribution Product outside the United States, subject to a two-year royalty-free period following launch of the Distribution Product in each applicable country. We will continue to pay royalties on net sales of the Distribution Product in the United States at rates ranging from mid-single digits to low double digits, and Fresenius Medical Care remains obligated to support adoption of the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses.
Previous report
On April 21, 2026, we entered into the Third Amendment to the distribution agreement with Fresenius Medical Care. Pursuant to the amendment, we have the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution agreement, as amended) on a worldwide basis. In connection with the reversion of ex-U.S. rights to us, we will pay Fresenius Medical Care low-single-digit royalties on net sales of the Distribution Product outside the United States, subject to a two-year royalty-free period following launch of the Distribution Product in each applicable country. We will continue to pay royalties on net sales of the Distribution Product in the United States at rates ranging from mid-single digits to low double digits, and Fresenius Medical Care remains obligated to support adoption of the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses.
Previous report
Cost of goods sold
Previous report
General and administrative expenses were comparable at $8.0 million and $7.8 million for the three months ended June 30, 2026 and 2025, respectively.
Previous report
Total Other Income (Expense), net
Previous report
General and administrative expenses were $16.0 million for each of the six months ended June 30, 2026 and 2025.
Previous report
Total Other Income (Expense), net
Reworded paragraphs (31)
Previous wording
In addition to extremity vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014. We also received the first Regenerative Medicine Advanced Therapy (“RMAT”) designation from the FDA, for the creation of vascular access for performing hemodialysis, in March 2017. In May 2023, we were granted the RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma, and in June 2024, we were granted the RMAT designation for the ATEV for patients with advanced PAD. In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.
Current wording
In addition to extremity vascular trauma, we and our collaborators have conducted Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014. We also received the first Regenerative Medicine Advanced Therapy (“RMAT”) designation from the FDA, for the creation of vascular access for performing hemodialysis, in March 2017. In May 2023, we were granted the RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma, and in June 2024, we were granted the RMAT designation for the ATEV for patients with advanced PAD. In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.
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, 2026 and December 31, 2025, we had an accumulated deficit of $781.3 million and $726.8 million, respectively, and working capital of $77.8 million and $49.4 million, respectively. Our operating losses were approximately $55.9 million and $52.9 million for the six months ended June 30, 2026 and 2025, 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, 2026 and December 31, 2025, we had an accumulated deficit of $796.8 million and $726.8 million, respectively, and working capital of $57.9 million and $49.4 million, respectively. Our operating losses were approximately $79.5 million and $77.3 million for the nine months ended September 30, 2026 and 2025, respectively.
Previous wording
Net cash flows used in operating activities were $47.2 million and $55.0 million during the six months ended June 30, 2026 and 2025, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from 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 continue to commercialize Symvess and advance our product candidates.
Current wording
Net cash flows used in operating activities were $62.1 million and $78.9 million during the nine months ended September 30, 2026 and 2025, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from 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 continue to commercialize Symvess and advance our product candidates.
Previous wording
As of June 30, 2026, we had cash and cash equivalents of $79.9 million and restricted cash of $0.4 million.
Current wording
As of September 30, 2026, we had cash and cash equivalents of $64.5 million and restricted cash of $0.4 million.
Previous wording
Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities and on the results of our ongoing commercial sales efforts. Since receiving FDA approval to commercialize Symvess in the vascular trauma indication, we generated product revenue of $0.4 million and $0.9 million for the three and six months ended June 30, 2026, respectively, and $1.4 million for the twelve months ended December 31, 2025. Our ability to generate sufficient product revenue to finance our operations will depend on the successful commercialization of Symvess and the advancement of our product candidates. Until such time, if ever, we expect to finance our operations primarily through the use of existing cash and cash equivalents, private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we plan to implement a program to delay, reduce, suspend or cease 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. See “Risk Factors” for additional information.
Current wording
Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities and on the results of our ongoing commercial sales efforts. Since receiving FDA approval to commercialize Symvess in the vascular trauma indication, we generated product revenue of $1.0 million and $1.9 million for the three and nine months ended September 30, 2026, respectively, and $1.4 million for the twelve months ended December 31, 2025. Our ability to generate sufficient product revenue to finance our operations will depend on the successful commercialization of Symvess and the advancement of our product candidates. Until such time, if ever, we expect to finance our operations primarily through the use of existing cash and cash equivalents, private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we plan to implement a program to delay, reduce, suspend or cease 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. See “Risk Factors” for additional information.
Previous 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. During the three and six months ended June 30, 2026, we generated $0.4 million and $0.9 million, respectively, in product revenue from sales of Symvess, compared with $0.1 million and $0.2 million, respectively, for the three and six months ended June 30, 2025. The remainder of our revenue has been derived from contracts. From inception through June 30, 2026, we have been awarded grants, including grants from the California Institute of Regenerative Medicine, the National Institutes of Health, 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. During the three and nine months ended September 30, 2026, we generated $1.0 million and $1.9 million, respectively, in product revenue from sales of Symvess, compared with $0.7 million and $1.0 million, respectively, for the three and nine months ended September 30, 2025. The remainder of our revenue has been derived from contracts. From inception through September 30, 2026, we have been awarded grants, including grants from the California Institute of Regenerative Medicine, the National Institutes of Health, and the Department of Defense, to support our development, production scaling and clinical trials of our product candidates.
Previous wording
Cost of goods sold consists of manufacturing costs associated with the production of Symvess, including materials, direct labor and manufacturing-related overhead. Cost of goods sold also includes royalty expense related to product sales, overhead associated with unused production capacity, and inventory reserves recorded to adjust inventory to its estimated net realizable value. Prior to FDA approval of Symvess for the vascular trauma indication in December 2024, manufacturing and material costs incurred in connection with product development were expensed as research and development costs as incurred, as commercialization and future economic benefit were not yet considered probable. Beginning in 2025, following commercialization of Symvess, certain manufacturing-related payroll and overhead costs previously included within research and development expenses were capitalized to inventory and recognized in cost of goods sold as product is sold. During the three and six months ended June 30, 2026, we recorded an inventory reserve to adjust certain inventory balances to the estimated net realizable value, which is reflected within cost of goods sold in the condensed consolidated statements of operations and comprehensive (loss) income.
Current wording
Cost of goods sold consists of manufacturing costs associated with the production of Symvess, including materials, direct labor and manufacturing-related overhead. Cost of goods sold also includes royalty expense related to product sales, overhead associated with unused production capacity, and inventory reserves recorded to adjust inventory to its estimated net realizable value. Prior to FDA approval of Symvess for the vascular trauma indication in December 2024, manufacturing and material costs incurred in connection with product development were expensed as research and development costs as incurred, as commercialization and future economic benefit were not yet considered probable. Beginning in 2025, following commercialization of Symvess, certain manufacturing-related payroll and overhead costs previously included within research and development expenses were capitalized to inventory and recognized in cost of goods sold as product is sold. During the six months ended June 30, 2026, we recorded a reserve to adjust certain inventory balances to their estimated net realizable value. This reserve is reflected within cost of goods sold for the nine months ended September 30, 2026, in the condensed consolidated statements of operations and comprehensive loss.
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, (iii) interest expense incurred on our Term Loan Facility, finance leases, and our former Purchase Agreement during the periods each were outstanding, and (iv) the change in fair value of our derivative liabilities and assets, 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 warrant liability related to the Loan Agreement; the former contingent derivative liability related to the terminated Purchase Agreement; a former liability related to a freestanding option agreement related to the terminated Purchase Agreement; a derivative liability related to our agreement with JDRF; a derivative liability related to the Loan Agreement; 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 each liability is outstanding, 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 our Term Loan Facility, finance leases, and our former Purchase Agreement during the periods each were outstanding, and (iv) the change in fair value of our derivative liabilities and assets, 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 warrant liability related to the Loan Agreement; the former contingent derivative liability related to the terminated Purchase Agreement; a former liability related to a freestanding option agreement related to the terminated Purchase Agreement; a derivative liability related to our agreement with JDRF; a derivative liability related to the Loan Agreement; and a former derivative asset related to our Common Stock Purchase Agreement, all of which are subject to remeasurement to fair value at each balance sheet date each liability is outstanding, resulting in a non-cash gain or loss.
Previous wording
Total revenue was $0.4 million for the three months ended June 30, 2026, compared with $0.3 million revenue for the three months ended June 30, 2025. Revenue for the three months ended June 30, 2026 consisted of product revenue from sales of Symvess in the United States. 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 $1.0 million for the three months ended September 30, 2026, compared with $0.8 million revenue for the three months ended September 30, 2025. Revenue for the three months ended September 30, 2026 consisted of product revenue from sales of Symvess in the United States. 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 an insignificant amount 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 $3.3 million for the six months ended June 30, 2026, compared to $0.4 million for the six months ended June 30, 2025. During the six months ended June 30, 2026, cost of goods sold included a $2.3 million inventory reserve to reduce certain inventory to its estimated net realizable value, $0.3 million in costs associated with excess capacity, and royalties on product sales.
Current wording
Cost of goods sold was $1.4 million for the three months ended September 30, 2026, compared to $0.3 million for the three months ended September 30, 2025. During the three months ended September 30, 2026, the cost of goods sold included a $0.8 million of costs associated with excess capacity and royalties on product sales. We recorded no additional inventory reserve expense during the three months ended September 30, 2026.
Previous wording
Research and development expenses were $18.1 million for the three months ended June 30, 2026, a decrease of $3.9 million, or 18%, compared with $22.0 million for the three months ended June 30, 2025. The decrease was primarily attributable to a $4.9 million reduction in materials and supplies expense, which was higher in the prior-year period due to non-commercial manufacturing production runs. The decrease was partially offset by a $1.5 million increase in other research and development expenses, primarily due to a $1.6 million decrease in the capitalization of manufacturing overhead costs in the current-year period resulting from fewer manufacturing runs compared to the prior-year period.
Current wording
Research and development expenses decreased by $3.2 million, or 18%, to $14.1 million for the three months ended September 30, 2026 from $17.3 million for the three months ended September 30, 2025. The decrease was primarily attributable to a $3.7 million reduction in materials and supplies expense and a $0.8 million reduction in payroll and personnel expense. The decrease was partially offset by a $2.0 million increase in other research and development expenses, primarily due to lower capitalization of manufacturing overhead costs in the current-year period resulting from fewer manufacturing runs compared with the prior-year period.
Previous wording
Total other expense, net was $9.8 million for the three months ended June 30, 2026, compared with $7.9 million for the three months ended June 30, 2025. The $1.9 million expense increase was primarily attributable to a $4.4 million increase in the non-cash loss from the fair value remeasurement of derivative liabilities, partially offset by a $2.8 million non-cash gain from the fair value remeasurement of the Contingent Earnout Liability.
Current wording
Total other income, net increased by $1.1 million to $8.0 million for the three months ended September 30, 2026 from $6.9 million for the three months ended September 30, 2025. The increase primarily reflected a $2.4 million increase in non-cash gains from the fair value remeasurement of derivative instruments, partially offset by a $1.5 million decrease in the non-cash gain from the fair value remeasurement of the Contingent Earnout Liability. The net gain on derivative instruments for the three months ended September 30, 2026 included a $0.7 million non-cash loss resulting from the remeasurement of the Common Stock Purchase Agreement derivative asset to a fair value of zero.
Previous wording
Total revenue was $0.9 million for the six months ended June 30, 2026, compared with $0.8 million revenue for the six months ended June 30, 2025. Revenue for the six months ended June 30, 2026 consisted primarily of product revenue from sales of Symvess in the United States. 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 $1.9 million for the nine months ended September 30, 2026, compared with $1.6 million revenue for the nine months ended September 30, 2025. Revenue for the nine months ended September 30, 2026 consisted of product revenue from sales of Symvess in the United States. Revenue for the nine months ended September 30, 2025 consisted of $1.0 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 $1.2 million for the three months ended June 30, 2026, compared to $0.2 million for the three months ended June 30, 2025. During the three months ended June 30, 2026, cost of goods sold included a $0.7 million inventory reserve to reduce certain inventory to its estimated net realizable value, $0.1 million in costs associated with excess capacity, and royalties on product sales.
Current wording
Cost of goods sold was $4.7 million for the nine months ended September 30, 2026, compared to $0.6 million for the nine months ended September 30, 2025. During the nine months ended September 30, 2026, cost of goods sold included a $2.3 million inventory reserve to reduce certain inventory to its estimated net realizable value and $1.2 million in costs associated with excess capacity and royalties on product sales.
Previous wording
Research and development expenses were comparable at $37.6 million and $37.4 million for the six months ended June 30, 2026 and 2025, respectively. Other research and development expenses increased by $1.8 million compared to the prior-year period, primarily due to a reduction in capitalized manufacturing overhead costs resulting from fewer manufacturing runs. This increase was partially offset by decreases of $0.6 million in materials and supplies expense and $0.9 million in professional and consulting costs included in external services expense, primarily due to the wind-down of certain programs.
Current wording
Research and development expenses decreased by $3.0 million, or 5%, to $51.7 million for the nine months ended September 30, 2026 from $54.7 million for the nine months ended September 30, 2025. The decrease was primarily attributable to a $4.3 million reduction in materials and supplies expense and a $1.3 million reduction in professional and consulting costs included in external services expense, primarily due to the wind-down of certain programs. These decreases were partially offset by a $3.8 million increase in other research and development expenses, primarily due to lower capitalization of manufacturing overhead costs resulting from fewer manufacturing runs.
Previous wording
Total other income, net was $1.5 million for the six months ended June 30, 2026, compared with $54.4 million for the six months ended June 30, 2025. The $52.9 million decrease was primarily attributable to lower non-cash gains, including decreases of $42.3 million from the fair value remeasurement of the Contingent Earnout Liability and $10.8 million from the fair value remeasurement of derivative liabilities.
Current wording
Total other income, net decreased by $51.8 million to $9.5 million for the nine months ended September 30, 2026 from $61.3 million for the nine months ended September 30, 2025. The decrease was primarily due to lower non-cash gains, including decreases of $43.8 million from the fair value remeasurement of the Contingent Earnout Liability and $8.5 million from the fair value remeasurement of derivative liabilities. The net gain on derivative instruments for the nine months ended September 30, 2026 included a $0.7 million non-cash loss resulting from the remeasurement of the Common Stock Purchase Agreement derivative asset to a fair value of zero.
Previous wording
Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and generated $0.4 million and $0.9 million of product revenue from sales of Symvess during the three and six months ended June 30, 2026, respectively, compared with $0.1 million and $0.2 million, respectively, for the three and six months ended June 30, 2025.
Current wording
Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and generated $1.0 million and $1.9 million of product revenue from sales of Symvess during the three and nine months ended September 30, 2026, respectively, compared with $0.7 million and $1.0 million, respectively, for the three and nine months ended September 30, 2025.
Previous wording
We have historically financed our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, including the Term Loan Facility, 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, 2026 and December 31, 2025, we had an accumulated deficit of $781.3 million and $726.8 million, respectively.
Current wording
We have historically financed our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, including the Term Loan Facility, 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, 2026 and December 31, 2025, we had an accumulated deficit of $796.8 million and $726.8 million, respectively.
Previous wording
As of June 30, 2026 and December 31, 2025, we had working capital of $77.8 million and $49.4 million, respectively. As of June 30, 2026 and December 31, 2025, we had cash and cash equivalents of $79.9 million and $50.5 million, respectively, and restricted cash of $0.4 million as of both dates.
Current wording
As of September 30, 2026 and December 31, 2025, we had working capital of $57.9 million and $49.4 million, respectively. As of September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $64.5 million and $50.5 million, respectively, and restricted cash of $0.4 million as of both dates.
Previous wording
We will not have sufficient liquidity to fund our operations beyond one year from the issuance of these interim financial statements if we are unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. As further disclosed in Note 10, in May 2026, we implemented a plan to reduce our workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and we have retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. We plan to seek additional funding through private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate additional capital may not be available to us when needed or on acceptable terms. If we are unable to raise 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. The accompanying unaudited condensed consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q have been prepared assuming that we will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should we be unable to continue as a going concern.
Current wording
We will not have sufficient liquidity to fund our operations beyond one year from the issuance of these interim financial statements if we are unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. As further disclosed in Note 10, in May 2026, we implemented a plan to reduce our workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and we have retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. We plan to seek additional funding through private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate additional capital may not be available to us when needed or on acceptable terms. If we are unable to raise 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. The accompanying unaudited condensed consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q have been prepared assuming that we will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should we be unable to continue as a going concern. See Note 1, Organization and Description of Business, to our accompanying condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.
Previous wording
On September 24, 2024, we entered into the Common Stock Purchase Agreement with Lincoln Park for an equity line financing, which provides that, subject to the terms and conditions set forth in the Common Stock Purchase Agreement, we have the sole right, but not the obligation, to sell to Lincoln Park shares of Common Stock having an aggregate value of up to $50.0 million over a 24-month period. We control the timing and amount of any sales to Lincoln Park. As of June 30, 2026, we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds, and as of June 30, 2026, we had $47.5 million in remaining availability for sales of our Common Stock under our Common Stock Purchase Agreement with Lincoln Park.
Current wording
On September 24, 2024, we entered into the Common Stock Purchase Agreement with Lincoln Park for an equity line financing, which provided that, subject to the terms and conditions set forth in the Common Stock Purchase Agreement, we had the sole right, but not the obligation, to sell to Lincoln Park shares of Common Stock having an aggregate value of up to $50.0 million over a 24-month period. Through September 30, 2026, we sold 500,000 shares of Common Stock to Lincoln Park under the Common Stock Purchase Agreement for aggregate gross proceeds of approximately $2.5 million, all of which were sold during the year ended December 31, 2025. We did not sell any shares under the Common Stock Purchase Agreement during the nine months ended September 30, 2026. As of September 30, 2026, $47.5 million of unused purchase capacity remained under the Common Stock Purchase Agreement. The Common Stock Purchase Agreement expired on October 1, 2026, and the remaining $47.5 million of purchase capacity expired unused and is no longer available to us as a source of liquidity.
Previous wording
On October 6, 2025, we entered into a securities purchase agreement with institutional investors pursuant to which the investors purchased approximately $60.0 million of Common Stock and October 2025 RDO Warrants in the October 2025 Registered Direct Offering. The net proceeds to us from the October 2025 Registered Direct Offering were approximately $56.5 million, after deducting placement agent’s fees and offering expenses of approximately $3.5 million. The October 2025 Registered Direct Offering closed on October 8, 2025.
Current wording
On October 6, 2025, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $60.0 million of Common Stock and October 2025 RDO Warrants in the October 2025 Registered Direct Offering. The net proceeds to us from the October 2025 Registered Direct Offering were approximately $56.5 million, after deducting placement agent’s fees and offering expenses of approximately $3.5 million. The October 2025 Registered Direct Offering closed on October 8, 2025.
Previous wording
On December 15, 2025, we entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P., as administrative agent and collateral agent for the lenders, which provides for a Term Loan Facility of up to $77.5 million in the aggregate that matures on December 1, 2029. The Term Loan Facility consists of (i) an initial term loan of $40.0 million, which was fully funded on December 15, 2025, (ii) a $12.5 million delayed draw term loan which will be made available between October 1, 2026 and March 31, 2027, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions, and (iii) a $25.0 million delayed draw term loan which will be made available at the discretion of the lenders between July 1, 2027 and June 30, 2028, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions. The proceeds from the initial term loan were used primarily to repay the remaining obligations under the Purchase Agreement, as discussed below.
Current wording
On December 15, 2025, we entered into the Loan Agreement with Avenue Venture Opportunities Fund II, L.P., as administrative agent and collateral agent for the lenders, which provides for a Term Loan Facility of up to $77.5 million in the aggregate that matures on December 1, 2029. The Term Loan Facility consists of (i) an initial term loan of $40.0 million, which was fully funded on December 15, 2025, (ii) a $12.5 million delayed draw term loan which will be made available between October 1, 2026 and March 31, 2027, at the discretion of the lenders, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions, and (iii) a $25.0 million delayed draw term loan which will be made available at the discretion of the lenders between July 1, 2027 and June 30, 2028, subject to the satisfaction of certain revenue, regulatory approval and liquidity conditions. The proceeds from the initial term loan were used primarily to repay the remaining obligations under the Purchase Agreement, as discussed below.
Previous wording
On September 1, 2022, we entered into a sales agreement with Jefferies LLC, acting as sales agent (the “Jefferies ATM Sales Agreement”), for the sale from time to time of up to $80.0 million of shares of Common Stock (the “Jefferies ATM Facility”). During the six months ended June 30, 2025, we sold an aggregate of 1,299,870 shares of Common Stock under the ATM Facility at an average price of $2.86 per share for net proceeds of approximately $3.6 million after deducting sales commissions of approximately $0.1 million. On November 21, 2025, we delivered a notice to Jefferies LLC terminating the Jefferies ATM Sales Agreement, which termination became effective 10 days thereafter.
Current wording
On September 1, 2022, we entered into a sales agreement with Jefferies LLC, acting as sales agent (the “Jefferies ATM Sales Agreement”), for the sale from time to time of up to $80.0 million of shares of Common Stock (the “Jefferies ATM Facility”). During the three months ended September 30, 2025, we sold an aggregate of 2,492,410 shares of Common Stock under the Jefferies ATM Facility at an average price of $2.64 per share for net proceeds of approximately $6.2 million. During the nine months ended September 30, 2025, we sold an aggregate of 3,792,280 shares of Common Stock under the Jefferies ATM Facility at an average price of $2.72 per share for net proceeds of approximately $9.8 million. On November 21, 2025, we delivered a notice to Jefferies LLC terminating the Jefferies ATM Sales Agreement, which termination became effective 10 days thereafter.
Previous wording
On December 16, 2025, we entered into a sales agreement with TD Cowen, acting as sales agent (the “TD Cowen ATM Facility”), pursuant to which we may sell shares of Common Stock from time to time up to an aggregate offering price of $60.0 million. During the six months ended June 30, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility at an average price of $1.16 per share for net proceeds of approximately $4.6 million. All such sales occurred during the first quarter of 2026. On March 19, 2026, we suspended and terminated the ATM Prospectus pursuant to which shares had been sold under the TD Cowen ATM Facility.
Current wording
On December 16, 2025, we entered into a sales agreement with TD Cowen, acting as sales agent (the “TD Cowen ATM Facility”), pursuant to which we may sell shares of Common Stock from time to time up to an aggregate offering price of $60.0 million. During the nine months ended September 30, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility at an average price of $1.16 per share for net proceeds of approximately $4.6 million. All such sales occurred during the first quarter of 2026. On March 19, 2026, we suspended and terminated the ATM Prospectus pursuant to which shares had been sold under the TD Cowen ATM Facility.
Previous wording
As of June 30, 2026, we had non-cancellable purchase commitments of $22.3 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, 2026. For additional information regarding our agreement with Fresenius Medical Care, see Note 11, 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 10 to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.
Current wording
As of September 30, 2026, we had non-cancellable purchase commitments of $19.5 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, 2026. For additional information regarding our agreement with Fresenius Medical Care, see Note 11, 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 10 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) continue to sell Symvess for the vascular trauma indication 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 AV access for hemodialysis 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) continue to sell Symvess for the vascular trauma indication 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 AV access for hemodialysis and submit a supplemental 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.
Previous wording
Net cash used in operating activities decreased by $7.8 million for the six months ended June 30, 2026, compared with the six months ended June 30, 2025. The decrease was primarily attributable to a favorable year-over-year change in manufacturing runs and inventory build. This decrease in cash used was partially offset by net unfavorable changes in other working capital components, including prepaid expenses, other current assets, and accounts payable.
Current wording
Net cash used in operating activities decreased by $16.8 million for the nine months ended September 30, 2026, compared with the nine months ended September 30, 2025, primarily due to fewer manufacturing runs and reduced inventory build, which was partially offset by an unfavorable change in accounts payable.
Previous wording
Net cash used in investing activities forthe six months ended June 30, 2026 and 2025 consisted of purchases of property and equipment.
Current wording
Net cash used in investing activities forthe nine months ended September 30, 2026 and 2025 consisted of purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2026 consisted primarily of $18.3 million of net proceeds from our March 2026 Registered Direct Offering, $53.8 million of net proceeds from our 2026 Public Offering and $4.6 million of net proceeds from the issuance of stock under our TD Cowen ATM Facility. 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 and $3.6 million of net proceeds from the issuance of stock under our Jefferies ATM Facility.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2026 consisted primarily of $18.3 million of net proceeds from our March 2026 Registered Direct Offering, $53.8 million of net proceeds from our 2026 Public Offering and $4.6 million of net proceeds from the issuance of stock under our TD Cowen ATM Facility. 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 Jefferies ATM Facility, partially offset by a $50.0 million payment on the revenue interest liability in connection with the Purchase Agreement Amendment.
Previous wording
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 the 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
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 the 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.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
In May 2026, we implemented a plan to reduce our workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and we have retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. We estimate that we will incur aggregate charges of approximately $0.8 million representing one-time cash expenditures for severance and other employee termination benefits, of which the majority has been incurred during the second quarter of 2026. We estimate net savings due to the workforce reductions and operating cost reductions, net of termination severance and benefits, totaling approximately $14.3 million.
Previous report — wording carried elsewhere
On June 10, 2026, we entered into an underwriting agreement with Barclays Capital Inc., BTIG, LLC and Titan Partners Group LLC, a division of American Capital Partners, LLC, as representatives of the several underwriters named therein, relating to the 2026 Public Offering. In the 2026 Public Offering, we sold the 2026 Firm Shares, consisting of 47,619,048 shares of
Previous report — wording carried elsewhere
Common Stock, at a price to the public of $1.05 per share. We also granted the underwriters a 30-day option to purchase up to an additional 7,142,857 shares of Common Stock at the same price as the 2026 Firm Shares, which the underwriters exercised on June 15, 2026. Our net proceeds from the 2026 Public Offering, including the sale of the 2026 Option Shares, were approximately $53.8 million after deducting underwriting discounts and commissions and offering expenses. The sale of the 2026 Firm Shares closed on June 12, 2026 and the sale of 2026 Option Shares closed on June 16, 2026.
Previous report — wording carried elsewhere
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report — wording carried elsewhere
See Note 1, Organization and Description of Business, to our accompanying condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.