Humacyte, Inc.
For the period ended Mar 31, 2026. Filed May 13, 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.
Mar 31, 2026 · Filed May 13, 2026
HUMA$0.45+13.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001818382-25-000132
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001193125-26-221755
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 130 previous paragraphs and 129 current paragraphs.
76 unchanged; 27 reworded; 25 added; 24 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 4 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 (25)
Current 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 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 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.
Current report
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. 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.
Current report
On March 4, 2026, we received a minimum purchase commitment of approximately $1.48 million of the Symvess ATEV to enable the education of surgeons, and the evaluation of Symvess by hospitals, in the Kingdom of Saudi Arabia. The evaluation of Symvess is planned to be conducted in parallel with ongoing negotiations with a KSA-based entity for establishment of a joint venture and license to commercialize Symvess within the country. We have agreed to not engage in negotiation of commercialization rights within the KSA with any other party through July 2, 2026. Although the purchase commitment described above is binding, the establishment of a joint venture and license and the finalization of definitive terms are subject to further negotiation between the parties as well as the execution of definitive agreements between the KSA-based entity and us.
Current report
On March 16, 2026, we filed a Marketing Authorization Application (“MAA”) with the Ministry of Health of the State of Israel for approval of Symvess for the vascular trauma indication. In response to requests from surgeons, we are also pursuing methods of making Symvess available on a hospital-by-hospital basis in advance of any future MAA approval in Israel.
Current report
On March 19, 2026, we delivered written notice to TD Cowen, that we were suspending and terminating the ATM Prospectus, relating to the sale of up to $60 million of Common Stock, that may be issued and sold pursuant to the Sales Agreement, dated as of December 16, 2025, by and between us and TD Cowen. We will not make any further sales of Common Stock pursuant to the Sales Agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Other than the suspension and termination of the ATM Prospectus, the Sales Agreement remains in full force and effect.
Current report
Also on March 19, 2026, we entered into certain securities purchase agreements, pursuant to which we agreed to issue and sell to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share. The net proceeds to us were approximately $18.3 million, after deducting the placement agent’s fees and estimated offering expenses payable by us. The offering closed on March 20, 2026.
Current report
As further disclosed in Note 12, Subsequent Events, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly 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 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 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.
Current report
Also, as further disclosed in Note 12, 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 is expected to be 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 during the remainder of 2026.
Current report
Cost of goods sold
Current report
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 months ended March 31, 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 report
General and Administrative Expenses
Current report
n/m - not meaningful
Current report
Cost of goods sold
Current report
Cost of goods sold was $2.0 million for the three months ended March 31, 2026, compared to $0.1 million for the three months ended March 31, 2025. During the three months ended March 31, 2026, cost of goods sold included a $1.6 million inventory reserve recorded to reduce certain inventory balances to their estimated net realizable value in connection with the initial commercialization of Symvess, excess capacity recorded as an expense, and royalty expense related to product sales.
Current report
Research and development expenses were $19.5 million for the three months ended March 31, 2026, representing an increase of $4.0 million, or 26%, from $15.4 million for the three months ended March 31, 2025. The increase was primarily driven by a $4.3 million increase in materials, primarily from non-commercial manufacturing runs associated with the CTEV and process improvement designed to reduce cost of goods sold going forward, and supplies expense, partially offset by $0.8 million decrease in external services.
Current report
General and Administrative Expenses
Current report
General and administrative expenses were $7.9 million and $8.1 million for the three months ended March 31, 2026 and 2025, respectively, and were relatively flat year-over-year.
Current report
Although we are a commercial-stage biotechnology platform company, we have a single product approved for commercial sale and have generated $0.5 million and $1.4 million, respectively, in product revenue from the sale of Symvess during the three months ended March 31, 2026 and twelve months ended December 31, 2025 respectively.
Current report
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 Loan Agreement 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 report
On March 19, 2026, we entered into certain securities purchase agreements pursuant to which we agreed to issue and sell to certain investors in a registered direct offering 25,000,000 shares of Common Stock at a price of $0.80 per share (the “March 2026 Registered Direct Offering”). The net proceeds to us from the March 2026 Registered Direct Offering were approximately $18.3 million, after deducting the placement agent’s fees and offering expenses of approximately $0.4 million. The March 2026 Registered Direct Offering closed on March 20, 2026.
Current report
ATM Facilities
Current report
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 three months ended March 31, 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. 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 report
Under the senior secured Term Loan Facility (see Note 6 to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report), we are required to make monthly interest payments beginning in January 2026 at a variable rate equal to the greater of 11.50% or the Wall Street Journal Prime Rate plus 4.50%. We are not required to make scheduled principal payments until December 1, 2027, or December 1, 2028 if the second tranche is funded, after which principal will be repaid in equal monthly installments through maturity in December 2029. In addition, the facility includes a contractual final payment fee of $2.4 million due at maturity. Because the interest rate is variable, our future interest expense and related cash interest payments may increase or decrease based on changes in rates. The Loan Agreement contains customary affirmative and negative covenants, certain liquidity requirements and customary events of default, and is secured by substantially all of our assets. See Note 6 to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.
Current report
Our finance lease relates to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed in June 2018. Our future contractual obligations under our lease agreement as of March 31, 2026 are as follows:
Current report
The decrease in net cash used in operating activities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily driven by changes in inventories. The prior-year period reflected an increase in inventory as the Company began capitalizing inventory following FDA approval and the commercial launch of Symvess.
Removed paragraphs (24)
Previous report
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 report
In October 2024, we submitted a New Technology Add-On Payment (“NTAP”) application for Symvess to the Centers for Medicare and Medicaid Services (“CMS”). In July 2025, CMS declined to approve our NTAP application. We may engage in discussions with CMS regarding the application, but there is no guarantee that CMS will reverse its decision within a given timeframe, or at all. We believe that the potential impact of the NTAP on commercial success is limited as only approximately 4.3% of vascular trauma patients are covered under Medicare reimbursement.
Previous report
We have inventory for which the production costs were recorded as an expense in 2024 prior to FDA approval. We expect cost of goods sold to normalize after utilization of this inventory. If market acceptance of Symvess does not occur at all or on a timely basis prior to the inventory shelf-life expiration, we may be required to write-off some or all inventory, which could affect our financial requirements and financial results. Cost of goods sold includes overhead related to unused production capacity, which was recorded as an expense during the three and nine months ended September 30, 2025, as well as royalties expense based on our product revenue.
Previous report
Cost of goods sold was $0.3 million for the three months ended September 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the three months ended September 30, 2024.
Previous report
Research and development expenses were $17.3 million for the three months ended September 30, 2025, representing a decrease of $5.7 million, or 25%, from $22.9 million for the three months ended September 30, 2024. The decrease was driven by a $3.0 million decrease in other research and development expense and $1.0 million decrease in payroll and personnel expenses related to the capitalization of overhead costs associated with the commercial manufacturing of Symvess, a $0.3 million decrease in external services, a $0.5 million decrease in clinical trials expense, and a $0.5 million decrease in materials and supplies expense.
Previous report
Selling, general and administrative expenses were $7.6 million and $7.3 million for the three months ended September 30, 2025 and 2024, respectively. The increase in selling, general and administrative expenses compared to the prior period of $0.3 million, or 4% , was primarily driven by the commercial launch of Symvess, and included a $0.8 million increase in payroll and personnel expenses and $0.3 million increase in professional fees, partially offset by a $1.0 million decrease in external services and consulting expenses.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Revenue
Previous report
Cost of goods sold was $0.6 million for the nine months ended September 30, 2025 and includes overhead related to unused production capacity which was recorded as an expense during the period. There was no cost of goods sold for the nine months ended September 30, 2024.
Previous report
Research and development expenses were $54.7 million for the nine months ended September 30, 2025, representing a decrease of $13.2 million, or 19%, from $67.9 million for the nine months ended September 30, 2024. The decrease was primarily driven by a $4.2 million decrease in materials and supplies expense, related to the capitalization of expenditures for inventory during the nine months ended September 30, 2025 following the commencement of commercial manufacturing to support the market launch of Symvess, a $2.0 million decrease in clinical trials expense, and a $5.4 million decrease in other research and development expenses related primarily to the capitalization of overhead costs associated with the commercial manufacturing of Symvess.
Previous report
Selling, general and administrative expenses were $23.6 million and $18.4 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in general and administrative expenses compared to the prior period of $5.2 million, or 28%, was primarily driven by the commercial launch of Symvess. Significant increases in expenses included a $4.9 million increase in payroll and personnel expenses.
Previous report
Total Other Income (Expense), net
Previous report
Total other income, net was $61.3 million for the nine months ended September 30, 2025, compared to total other expense, net of $41.5 million for the nine months ended September 30, 2024. The $102.7 million change was primarily attributable to an $87.8 million non-cash gain from the fair value remeasurement of the Contingent Earnout Liability and a $17.5 million non-cash gain from the fair value remeasurement of derivative liabilities.
Previous report
As of September 30, 2025, we had $47.5 million in remaining availability for sales of Common Stock under our Common Stock Purchase Agreement with Lincoln Park and $62.7 million in remaining availability for sales of Common Stock under our ATM Facility.
Previous report
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 report
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 report
ATM Facility
Previous report
Revenue Interest Purchase Agreement
Previous report
On May 12, 2023, we entered into the Purchase Agreement with the Purchasers and another affiliate of Oberland Capital Management LLC, as agent for the Purchasers, to obtain financing in respect to the further development and commercialization of our ATEV, to repay our then outstanding credit facility with SVB, and for other general corporate purposes. Pursuant to the Purchase Agreement and subject to customary closing conditions, the Purchasers have purchased certain revenue interests from us in exchange for an aggregate investment amount of up to $150.0 million. Under the terms of the Purchase Agreement, $40.0 million of the Investment Amount, less certain transaction expenses, was funded on May 12, 2023, which was used to repay in full and retire our indebtedness under our loan agreement with SVB, with the remaining proceeds funded to the Company. On March 11, 2024, $20.0 million of the Investment Amount was funded to the Company. On December 19, 2024, the FDA granted full approval for our BLA for the vascular trauma indication, and we elected not to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we are not entitled to draw on any further installments under the Purchase Agreement. See Note 7 — Revenue Interest Purchase Agreement to the condensed consolidated financial statements for additional details about this financing transaction.
Previous report
On February 18, 2024, we agreed with the Purchasers and the Agent, to waive certain breaches related to, and extend the deadline for certain post-closing obligations under, the Purchase Agreement, including the requirement for us to deliver a leasehold mortgage in favor of the Agent over our headquarters. On May 8, 2024, we reached an agreement with the Purchasers to amend the Purchase Agreement to remove requirements related to the leasehold mortgage. In exchange for the removal of this requirement, on August 14, 2024 we funded an account in the amount of $54.0 million, over which the Agent has certain consent and other rights to $50.0 million of the funds. See Note 7 for further information.
Previous report
On September 17, 2025, we entered into the Purchase Agreement Amendment with the Purchasers and the Agent to amend the Purchase Agreement. In connection with the Purchase Agreement Amendment, we made a $50 million repayment under the Purchase Agreement, funded from the restricted cash maintained for the benefit of the Agent. Additionally, pursuant to the Purchase Agreement Amendment, we are no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent unless the Purchase Agreement has not been repaid in full by December 31, 2025, at which point we will be required to maintain $12.5 million in such account. Under the Purchase Agreement, as of September 30, 2025, we had $20.7 million recorded as a revenue interest liability on our condensed consolidated financial statements. For additional information regarding the Purchase Agreement, see Note 7 — Revenue Interest Purchase Agreement to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.
Previous report
On September 29, 2025, we executed a Sixth Amendment to our lease agreements that extended the lease term and modified key financial terms. Additional details regarding the amendment and its impact are provided in Note 8 — Leases to the condensed consolidated financial statements. Our future contractual obligations under our lease agreement as of September 30, 2025 are as follows:
Previous report
The increase in net cash used in operating activities from thenine months ended September 30, 2024 tothe nine months ended September 30, 2025 was primarily due to increased spending on preclinical, clinical and commercial activities as well as payroll and personnel expenses, expansion of clinical development of the ATEV for use in AV access, and our commercial launch of Symvess.
Previous report
We are an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012 (the “JOBS Act”), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies until it is no longer an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We expect to use the extended transition period and, therefore, while we are an emerging growth company we will not be subject to new or revised accounting standards at the same time that they become applicable to other public companies that are not emerging growth companies, unless we choose to early adopt a new or revised accounting standard. This may make it difficult or impossible to compare our financial results with the financial results of another public company because of the potential differences in accounting standards used.
Reworded paragraphs (27)
Previous wording
We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs. On December 19, 2024, the FDA granted full approval for the ATEV under the brand name Symvess TM 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. Our ATEVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. We are developing a portfolio, or “cabinet”, of ATEVs with varying diameters and lengths. The ATEV cabinet would initially target the vascular repair, reconstruction and replacement market, including use in vascular trauma, AV access for hemodialysis and PAD. We are also developing the ATEV for CABG and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular Pancreas or BVP). We will continue to explore the application of our technology across a broad range of markets and indications, including the development of urinary conduit, trachea, esophagus and other novel cell delivery systems.
Current wording
We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs. On December 19, 2024, the FDA granted full approval for the ATEV under the brand name Symvess® 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. Our ATEVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. We are developing a portfolio, or “cabinet,” of ATEVs with varying diameters and lengths. The ATEV cabinet would initially target the vascular repair, reconstruction and replacement market, including use in vascular trauma, AV access for hemodialysis and PAD. We are also developing the ATEV for CABG and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular Pancreas or BVP). We will continue to explore the application of our technology across a broad range of markets and indications, including the development of urinary conduit, trachea, esophagus and other novel cell delivery systems.
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 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 September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively, and working capital of $15.8 million and $27.9 million, respectively. Our operating losses were approximately $24.4 million and $77.3 million for the three and nine months ended September 30, 2025, respectively, and $30.2 million and $86.3 million for the three and nine months ended September 30, 2024, respectively.
Current wording
We have incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $744.5 million and $726.8 million, respectively, and working capital of $47.4 million and $49.4 million, respectively. Our operating losses were approximately $28.9 million and $23.2 million for the three months ended March 31, 2026 and 2025, respectively.
Previous wording
Net cash flows used in operating activities were $78.9 million and $71.5 million during the nine months ended September 30, 2025 and 2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations. We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future as we begin to commercialize Symvess and advance our product candidates.
Current wording
Net cash flows used in operating activities were $25.1 million and $28.6 million during the three months ended March 31, 2026 and 2025, 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 September 30, 2025, we had cash and cash equivalents of $19.5 million and restricted cash of $0.4 million. We believe our cash and cash equivalents on hand and existing capacity under our Common Stock Purchase Agreement will be sufficient to fund operations for at least 12 months from the date of this Quarterly Report. See Note 1 — Organization and Description of Business in the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding this assessment.
Current wording
As of March 31, 2026, we had cash and cash equivalents of $48.5 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 the results of our commercial sales efforts. We recently received FDA approval to commercialize Symvess and have only recently generated revenue from the sale of commercialized products. Our ability to generate product revenue will depend on the successful development and commercialization of Symvess and our product candidates. Until such time, if ever, we expect to finance our operations through the use of existing cash and cash equivalents, the sale of equity, debt, financings, debt refinancings or restructurings or through potential collaborations with other companies, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our 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 $0.5 million and $1.4 million in product revenue for the three months ended March 31, 2026, and twelve months ended December 31, 2025, respectively. 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
•commercialize Symvess via U.S. market launch for indications in vascular trauma and, if approved, in AV access for hemodialysis;
Current wording
continue to generate revenue from sales of Symvess in the United States for the indication in vascular trauma and, if approved, via U.S. market launch for the indication in AV access for hemodialysis;
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. From inception through September 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.
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 months ended March 31, 2026 and 2025, we have generated $0.5 million and $0.1 million, respectively, in product revenue from the sale of Symvess. The remainder of our revenue has been derived from contracts. From inception through March 31, 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
Since our inception, we have focused our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing and refining our manufacturing process and activities related to regulatory filings for our product candidates. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:
Current wording
Prior to our recent shift in focus to the sale of Symvess for the vascular trauma indication, we have historically focused, and continue to focus a substantial portion of our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing and refining our manufacturing process and activities related to regulatory filings for our product candidates. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:
Previous wording
Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance, human resources, commercialization, and administrative support functions, which also include stock-based compensation expenses and benefits for such employees. Other significant general and administrative expenses include facilities costs, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents.
Current wording
General and administrative expenses consist primarily of salaries and related costs for employees in executive, finance, human resources, commercialization, and administrative support functions, which also include stock-based compensation expenses and benefits for such employees. Other significant general and administrative expenses include facilities costs, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents.
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 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 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.
Previous wording
Total revenue was $0.8 million for the three months ended September 30, 2025, compared to no revenue for the three months ended September 30, 2024. Revenue for the three months ended September 30, 2025 consisted of $0.7 million of product revenue from sales of Symvess in the United States and $0.1 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.
Current wording
Total revenue was $0.5 million for the three months ended March 31, 2026, compared to $0.5 million revenue for the three months ended March 31, 2025. Revenue for the three months ended March 31, 2026 consisted primarily of product revenue from sales of Symvess in the United States. 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.
Previous wording
Total other income, net was $6.9 million for the three months ended September 30, 2025 compared to total other expense, net of $9.0 million for the three months ended September 30, 2024. The increase in net income of $15.8 million was primarily attributable to a $13.4 million non-cash gain from the fair value remeasurement of the Contingent Earnout Liability and a $3.0 million non-cash gain from the fair value remeasurement of the derivative liabilities.
Current wording
Total other income, net was $11.3 million for the three months ended March 31, 2026 compared to total other income, net of $62.3 million for the three months ended March 31, 2025. The $51.0 million decrease in other income, net was primarily driven by lower non-cash gains, including a $45.0 million decrease from the fair value remeasurement of the Contingent Earnout Liability and a $6.4 million decrease from the fair value remeasurement of derivative liabilities.
Previous wording
We have historically financed our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, the Purchase Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $702.0 million and $686.0 million, respectively.
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 March 31, 2026 and December 31, 2025, we had an accumulated deficit of $744.5 million and $726.8 million, respectively.
Previous wording
As of September 30, 2025 and December 31, 2024, we had working capital of $15.8 million and $27.9 million, respectively. As of September 30, 2025 and December 31, 2024, we had cash and cash equivalents of $19.5 million and $44.9 million, respectively, and restricted cash of $0.4 million and $50.4 million, respectively. We funded the restricted cash account on August 14, 2024, in accordance with our amended Purchase Agreement, of which $50.0 million was not subject to our unilateral control. In connection with the Purchase Agreement Amendment, the Company made the Purchase Agreement Amendment Payment of $50.0 million, funded from the restricted cash previously maintained for the benefit of the Agent. As a result of the Purchase Agreement Amendment Payment, the Company is no longer obligated to maintain $50.0 million of restricted cash in an account for the benefit of the Agent unless the Purchase Agreement has not been repaid in full by December 31, 2025, at which point the Company will be required to maintain $12.5 million in such account.
Current wording
As of March 31, 2026 and December 31, 2025, we had working capital of $47.4 million and $49.4 million, respectively. As of March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $48.5 million and $50.5 million, respectively, and restricted cash of $0.4 million as of both dates.
Previous 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.
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 12, 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 October 6, 2025, we entered into a securities purchase agreement with institutional investors pursuant to which the investors purchased approximately $60.0 million worth 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 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.
Previous wording
On September 1, 2022, we entered into the ATM Facility for the sale from time to time of up to $80.0 million of shares of Common Stock. As of September 30, 2025, we have sold an aggregate of 5,125,876 shares of Common Stock under the ATM Facility at an average price of $3.38 per share for net proceeds of approximately $16.8 million after deducting sales commissions of approximately $0.5 million. As of September 30, 2025, we had $62.7 million in remaining availability for sales of Common Stock under the ATM Facility.
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 March 31, 2025, we sold an aggregate of 75,793 shares of Common Stock under the Jefferies ATM Facility at an average price of $5.04 per share for net proceeds of approximately $0.4 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
Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) repayments pursuant to the Purchase Agreement; (3) employee wages, benefits, and incentives; (4) financing and operating lease payments (for additional information see below), and (5) payments under our JDRF Agreement (see Note 12 — Commitments and Contingencies to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report). We have also entered into contracts with CROs primarily for clinical trials. These contracts generally provide for termination upon limited notice, and therefore we believe that our non-cancellable obligations under these agreements are not material. Moreover, we may be subject to additional material cash requirements that are contingent upon the occurrence of certain events, for example, legal contingencies, uncertain tax positions, and other matters.
Current wording
Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) manufacturing and commercialization expenditures; (3) employee wages, benefits, and incentives; (4) financing lease payments (for additional information see below), and (5) debt service obligations under our senior secured Term Loan Facility (for additional information see below and Note 6, Debt, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report). We have also entered into contracts with CROs primarily for clinical trials. These contracts generally provide for termination upon limited notice, and therefore we believe that our non-cancellable obligations under these agreements are not material. Moreover, we may be subject to additional material cash requirements that are contingent upon the occurrence of certain events, for example, legal contingencies, uncertain tax positions, and other matters.
Previous wording
As of September 30, 2025, we had non-cancellable purchase commitments of $24.2 million for supplies and services that are primarily for research and development. We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at September 30, 2025. For additional information regarding our agreement with Fresenius Medical Care, see Note 13 — Related Party Transactions to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report. For additional information regarding our agreements with Duke University, Yale University and JDRF, see Note 12 — Commitments and Contingencies to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report.
Current wording
As of March 31, 2026, we had non-cancellable purchase commitments of $27.8 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, 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) 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.
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 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
Until such time, if ever, as we are able to successfully commercialize Symvess and to develop and commercialize our product candidates, we expect to continue financing our operations 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. Adequate capital may not be available to us when needed or on acceptable terms. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we are unable to raise capital, we plan to implement a program that delays, reduces, suspends or ceases 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.
Current wording
Until such time, if ever, as we are able to successfully commercialize Symvess and to develop and commercialize our product candidates, we expect to continue financing our operations 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. Adequate capital may not be available to us when needed or on acceptable terms. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in additional fixed payment obligations. If we are unable to raise capital, we plan to implement a program that delays, reduces, suspends or ceases 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.
Previous wording
(1) Primarily includes depreciation, amortization related to our leases, stock-based compensation expense, non-cash interest expense related to our revenue interest liability and our JDRF Award liability, and the changes in fair value of our Contingent Earnout Liability and our derivative liabilities and asset.
Current wording
(a) Primarily includes depreciation; amortization related to our leases; stock-based compensation expense; non-cash interest expense related to our revenue interest liability, our JDRF Award liability (defined above), and our Term Loan Facility (defined above); amortization of debt discount related to our Term Loan Facility; the changes in fair value of our Contingent Earnout Liability (defined above) and our derivative liabilities and asset; and inventory write-down to net realizable value.
Previous wording
Net cash used in investing activities forthe nine months ended September 30, 2025 and September 30, 2024 consisted of purchases of property and equipment.
Current wording
Net cash used in investing activities forthe three months ended March 31, 2026 and March 31, 2025 consisted of purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of $46.7 million of net proceeds from our 2025 Public Offering and $9.8 million of net proceeds from the issuance of stock under our ATM Facility, partially offset by a $50.0 million payment on the revenue interest liability in connection with the Purchase Agreement Amendment. Net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of $43.0 million of net proceeds from our 2024 Public Offering and $19.5 million of proceeds from the Purchase Agreement.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2026 consisted primarily of $18.7 million of net proceeds from our March 2026 Registered Direct 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 three months ended March 31, 2025 consisted primarily of $47.0 million of net proceeds from our 2025 Public Offering.
Previous wording
Emerging Growth Company and Smaller Reporting Company Status
Current wording
Smaller Reporting Company Status
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”), 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.
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”), 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Total revenue was $1.6 million for the nine months ended September 30, 2025, compared to no revenue for the nine months ended September 30, 2024. Revenue for the nine months ended September 30, 2025 consisted of $0.9 million of product revenue from sales of Symvess in the United States and $0.6 million of revenue earned related to research and development services pursuant to a research contract with a large medical technology company.
Previous report — wording carried elsewhere
The following table discloses the breakdown of research and development expenses for the periods indicated:
Previous report — wording carried elsewhere
On February 29, 2024, we entered into an underwriting agreement in connection with the 2024 Public Offering. The net proceeds to us from the 2024 Public Offering were approximately $43.0 million, after deducting underwriting discounts and commissions and offering expenses. The 2024 Public Offering closed on March 5, 2024.