The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q ("Quarterly Report") and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 ("Annual Report"), filed with theSecurities and Exchange Commission (the "SEC") onMarch 29, 2022 . In addition, you should read the "Risk Factors" and "Information Regarding Forward-Looking Statements" sections of this Quarterly Report and our Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context indicates otherwise, references in this Quarterly Report to the "Company," "Humacyte ," "we," "us," "our" and similar terms refer toHumacyte, Inc. (formerly known asAlpha Healthcare Acquisition Corp. ) and its consolidated subsidiaries (includingHumacyte Global, Inc. ) following the Merger (defined below); references to "Legacy Humacyte" refer toHumacyte, Inc. prior to the Merger; and references to "AHAC" refer toAlpha Healthcare Acquisition Corp. prior to the Merger. Overview We are pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. We believe our technology has the potential to overcome limitations in existing standards of care and address the lack of significant innovation in products that support tissue repair, reconstruction and replacement. We are leveraging our novel, scalable technology platform to develop proprietary product candidates for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. We are initially using our proprietary, scientific technology platform to engineer and manufacture human, acellular vessels ("HAVs"). Our investigational HAVs 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 HAVs with varying diameters and lengths. The HAV cabinet would initially target the vascular repair, reconstruction and replacement market, including use in vascular trauma; arteriovenous ("AV") access for hemodialysis, peripheral arterial disease ("PAD"); and coronary artery bypass grafting ("CABG"). In addition, we are developing our HAVs for pediatric heart surgery and the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our biovascular pancreas). 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. We believe there is substantial clinical demand for safe and effective vascular conduits to replace and repair blood vessels throughout the body. Vascular injuries resulting from trauma are common in civilian and military populations, frequently resulting in the loss of either life or limb. Existing treatment options in the vascular repair, reconstruction and replacement market include the use of autologous vessels and synthetic grafts, which we believe suffer from significant limitations. For example, the use of autologous veins to repair traumatic vascular injuries can lead to significant morbidity associated with the surgical wounds created for vein harvest and prolonged times to restore blood flow to injured limbs leading to an increased risk of amputation and infection. Synthetic grafts are often contraindicated in the setting of vascular trauma due to higher infection risk that can lead to prolonged hospitalization and limb loss. Given the competitive advantages our HAVs are designed to have over existing vascular substitutes, we believe that HAVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs. We are currently conducting Phase II and Phase III trials of our 6 millimeter HAV across two therapeutic indications, vascular trauma and AV access for hemodialysis, as well as continuing long-term follow up of patients in our Phase II PAD studies. We were granted Fast Track designation by the FDA for our 6 millimeter HAV 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, inMarch 2017 . In addition, in 2018 our HAV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite theFDA's review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel. Upon completion of our Phase III trials, we intend to submit a Biologics License Application ("BLA") to the FDA for an indication in vascular trauma in mid-2023. 31
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We have generated no product revenue and incurred operating losses and negative cash flows from operations in each year since our inception in 2004. As ofSeptember 30, 2022 andDecember 31, 2021 , we had an accumulated deficit of$422.8 million and$414.6 million , respectively, and working capital of$156.7 million and$218.3 million , respectively. Our operating losses were approximately$23.5 million and$63.8 million for the three and nine months endedSeptember 30, 2022 , respectively, and$20.5 million and$59.6 million for the three and nine months endedSeptember 30, 2021 , respectively. Net cash flows used in operating activities were$52.2 million and$59.7 million during the nine months endedSeptember 30, 2022 and 2021, 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 advance our product candidates. As ofSeptember 30, 2022 , we had cash and cash equivalents and short-term investments of$171.7 million . We believe our cash and cash equivalents and short-term investments on hand will be sufficient to fund operations, including clinical trial expenses and capital expenditure requirements, 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. Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities. To date, we have not generated any revenue from the sale of commercialized products. Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candidates. Until such time, if ever, we expect to finance our operations through the use of existing cash and cash equivalents and short-term investments, the sale of equity or debt, borrowings under credit facilities, or through potential collaborations, 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. We expect to continue to incur significant expenses and to increase operating losses for at least the next several years. We anticipate that our expenses will increase substantially as we seek to:
•obtain marketing approval for our 6 millimeter HAV for vascular repair, reconstruction and replacement, including for vascular trauma and AV access for hemodialysis;
•commercialize the HAV via U.S. market launches in vascular trauma and hemodialysis AV access;
•scale out our manufacturing facility to the extent required to satisfy potential demand following any receipt of marketing approval;
•continue our preclinical and clinical development efforts;
•maintain, expand and protect our intellectual property portfolio;
•add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and
•continue operating as a public company, which includes higher costs associated with hiring additional personnel, director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Securities Exchange Act of 1934 (the "Exchange Act") and rules implemented by theSEC andThe Nasdaq Stock Market LLC ("Nasdaq").
Merger and Public Company Costs
OnAugust 26, 2021 (the "Closing Date"), Legacy Humacyte andAHAC consummated a merger pursuant to that certain Business Combination Agreement, dated as ofFebruary 17, 2021 (the "Merger Agreement"), by and among Legacy Humacyte,AHAC andHunter Merger Sub, Inc. ("Merger Sub"), aDelaware corporation and wholly owned subsidiary ofAHAC . As contemplated by the Merger Agreement, Merger Sub merged with and into Legacy Humacyte, with Legacy Humacyte continuing as the surviving corporation and as a wholly owned subsidiary ofAHAC (the "Merger"). On the Closing Date,AHAC changed its name toHumacyte, Inc. and Legacy Humacyte changed its name toHumacyte Global, Inc. Operations prior to the Merger included in this Quarterly Report are those of Legacy Humacyte. 32
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Pursuant to the terms of the Merger Agreement, at the effective time of the Merger (the "Effective Time"), (1) each outstanding share of common stock of Legacy Humacyte ("Legacy Humacyte common stock") was cancelled and converted into the right to receive approximately 0.26260 shares of the Company's common stock, par value$0.0001 per share ("Common Stock"), and (2) each outstanding share of preferred stock of Legacy Humacyte ("Legacy Humacyte preferred stock") was cancelled and converted into the aggregate number of shares of Common Stock that would be issued upon conversion of the shares of Legacy Humacyte preferred stock based on the applicable conversion ratio immediately prior to the Effective Time, multiplied by approximately 0.26260, resulting in the issuance of a total of 75,656,935 shares of Common Stock. Prior holders of shares of Legacy Humacyte common stock and Legacy Humacyte preferred stock also received the contingent right to receive certain Contingent Earnout Shares (as defined below), for each share owned by each such Legacy Humacyte stockholder that was outstanding immediately prior to the closing of the Merger (the "Closing"). In addition, certain investors purchased an aggregate of 17,500,000 shares of Common Stock (such investors, the "PIPE Investors ") in a private placement that closed concurrently with the Closing for an aggregate purchase price of$175 million (the "PIPE Financing"). Additionally, at the Closing, 2,500,000 shares ofAHAC's Class B common stock ("Founder Shares") automatically converted into shares of Common Stock on a one-for-one basis. Following the Closing Date, former holders of Legacy Humacyte common stock and Legacy Humacyte preferred stock may receive up to 15,000,000 additional shares of Common Stock ("Contingent Earnout Shares") in the aggregate in two equal tranches if the volume-weighted average closing sale price of our Common Stock is greater than or equal to$15.00 and$20.00 , respectively, for any 20 trading days within any 30 consecutive trading day period. Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the exchange ratio established in the Merger Agreement.
Impact of COVID-19
The COVID-19 pandemic, which began inDecember 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of the outbreak, including shelter-in-place orders and the mandatory shutdown of certain businesses. The outbreak and government measures taken in response have had a significant impact, both direct and indirect, on our business, as supply chains have been disrupted, and facilities and production have been suspended. The future progression of the COVID-19 pandemic, including any existing or potential variants of the virus which causes COVID-19, and its effects on our business and operations are uncertain. The COVID-19 pandemic may affect our ability to initiate and complete preclinical studies, delay our clinical trials or future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. The pandemic has already caused significant disruptions in the financial markets and may continue to cause such disruptions, which could impact our ability to raise additional funds to support our operations. Moreover, the pandemic has significantly impacted economies worldwide and could result in adverse effects on our business and operations. To date, the COVID-19 pandemic has not resulted in material financial impacts or impairment losses in the carrying values of our assets and we are not aware of any specific related event or circumstance that would require us to revise the estimates reflected in our financial statements. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including current and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, the emergence of new virus variants, and the duration and intensity of the related economic impact of the COVID-19 pandemic.
Components of Results of Operations
Revenue
To date, we have not generated revenue from the sale of any products. All of our revenue has been derived from government and other grants. Since inception we have been awarded grants from theCalifornia Institute of Regenerative Medicine ("CIRM"), theNational Institutes of Health ("NIH"), and theDepartment of Defense ("DoD"), to support our development, production scaling and clinical trials of our product candidates. We may generate revenue in the future from government and other grants, payments from future license or collaboration agreements and, if any of our product candidates receive marketing approval, from product sales. We expect that any revenue we generate will fluctuate from quarter to quarter. If we fail to complete the development of, or obtain marketing approval for, our product candidates in a timely manner, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected. 33
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Research and Development Expenses
Since our inception, we have focused our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing 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:
•salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits;
•fees paid to consultants and clinical research organizations ("CROs"), including in connection with our clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis;
•allocation of facility lease and maintenance costs;
•depreciation of leasehold improvements, laboratory equipment and computers;
•costs related to purchasing raw materials and producing our product candidates for clinical trials;
•costs related to compliance with regulatory requirements;
•costs related to our manufacturing development and expanded-capabilities initiatives; and
•license fees related to in-licensed technologies.
The majority of our research and development resources are currently focused on our Phase II and III clinical trials for our 6 millimeter HAV and other work needed to obtain marketing approval for our 6 millimeter HAV for use for vascular repair, reconstruction and replacement, including vascular trauma and AV access in hemodialysis inthe United States . We have incurred and expect to continue to incur significant expenses in connection with these and our other clinical development efforts, including expenses related to regulatory filings, trial enrollment and conduct, data analysis, patient follow up and study report generation for our Phase II and Phase III clinical trials. We do not allocate all of our costs by each research and development program for which we are developing our cabinet of HAVs, as a significant amount of our development activities broadly support multiple programs that use our technology platform. We plan to further increase our research and development expenses for the foreseeable future as we continue the development of our proprietary scientific technology platform and our novel manufacturing paradigm. The successful development of our preclinical and clinical product candidates is highly uncertain. At this time, we cannot estimate with any reasonable certainty the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of any of our preclinical or clinical product candidates or the period, if any, in which material net cash inflows from these product candidates may commence. This is due to the numerous risks and uncertainties associated with the development of our product candidates, including: •the scope, rate of progress, expense and results of our preclinical development activities, our ongoing clinical trials and any additional clinical trials that we may conduct, and other research and development activities;
•successful patient enrollment in and the initiation and completion of clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable
regulatory authorities including the
•the extent of any required post-marketing approval commitments to applicable regulatory authorities;
•development of clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that it or its third-party manufacturers are able to successfully manufacture our product;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulations;
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•launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others;
•the degree of market acceptance of any product candidates that obtain marketing approval; and
•maintaining a continued acceptable safety profile following approval, if any, of our product candidates.
A change in the outcome of any of these variables could lead to significant changes in the costs and timing associated with the development of our product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate being required to conduct in order to complete the clinical development of any of our product candidates, or if we experience significant delays in the enrollment or the conduct of any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
General and Administrative Expenses
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. We expect our general and administrative expenses will continue to increase for the foreseeable future to support our expanded infrastructure and increased costs of operating as a public company and as we prepare for our anticipated commercial launch of the HAV. These increases are expected to include increased employee-related expenses, increased sales and marketing expenses, and increased director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by theSEC , as well as Nasdaq rules.
Other Income (Expense), Net
Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger, and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents and short-term investments, (iii) interest expense incurred on our Loan Agreement, finance leases, and our PPP loan during the periods each were outstanding, (iv) a change in fair value of private placement common stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger, and which are subject to remeasurement to fair value at each balance sheet date resulting in a non-cash gain or loss, (v) a non-cash gain on PPP loan forgiveness during the nine months endedSeptember 30, 2021 , and (vi) during the nine months endedSeptember 30, 2021 , legal, accounting, and underwriting fees and other costs directly related to the consummation of the Merger that were associated with the aforementioned warrant liabilities. 35
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Results of Operations
Comparison of the Three Months Ended
Three Months Ended September 30, Change ($ in thousands) 2022 2021 $ % Revenue$ 31 $ 241 $ (210) (87) % Operating expenses: Research and development 17,337 15,386 1,951 13 % General and administrative 6,188 5,398 790 15 % Total operating expenses 23,525 20,784 2,741 13 % Loss from operations (23,494) (20,543) (2,951) 14 % Other income (expense), net Change in fair value of Contingent Earnout Liability (962) (9,768) 8,806 (90) % Interest expense (1,641) (1,204) (437) 36 % Other income (expense), net 816 (48) 864 * Total other expense, net (1,787) (11,020) 9,233 (84) % Net loss$ (25,281) $ (31,563) $ 6,282 (20) % * Not meaningful Grant Revenue For the three months endedSeptember 30, 2022 and 2021, revenue was less than$0.1 million and approximately$0.2 million , respectively, and related to our grant fromDoD . The decrease in revenue of$0.2 million , or 87%, relates to the timing of reimbursement of certain allowable costs related to our grant fromDoD , currently estimated to total approximately$6.8 million over the life of the grant.
Research and Development Expenses
The following table discloses the breakdown of research and development expenses: Three Months Ended September 30, Change ($ in thousands) 2022 2021 $ % External services$ 4,542 $ 3,801 $ 741 19 % Materials and supplies 3,131 2,947 184 6 % Payroll and personnel expenses 6,448 5,775 673 12 % Other research and development expenses 3,216 2,863 353 12 %$ 17,337 $ 15,386 $ 1,951 13 % Research and development expenses increased by$2.0 million , or 13%, from$15.4 million for the three months endedSeptember 30, 2021 to$17.3 million for the three months endedSeptember 30, 2022 . The increase was primarily driven by expenses to support our expanded research and development initiatives, including (i) increased salaries and benefits of$0.9 million , (ii) a$0.7 million increase in external services, (iii) a$0.4 million increase in other research and development expenses including software costs, professional fees and facility maintenance, and (iv) a$0.2 million increase in the purchase of materials and supplies to be used in the development of our commercial-scale manufacturing process and other research and development initiatives, partially offset by a$0.3 million decrease in non-cash stock compensation expense. 36
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General and Administrative Expenses
General and administrative expenses were$6.2 million and$5.4 million for the three months endedSeptember 30, 2022 and 2021, respectively. The increase in general and administrative expenses during this period of$0.8 million , or 15%, was primarily driven by expenses associated with the transition to public company status and company growth, including (i) a$0.4 million increase in salaries and benefits due to higher headcount, including the initial members of the planned commercial launch team, (ii) a$0.3 million increase in external services and (iii) a$0.2 million increase in professional fees, partially offset by a$0.1 million decrease in non-cash stock compensation expense.
Total Other Expense, net
Total other expense, net was$1.8 million and$11.0 million for the three months endedSeptember 30, 2022 and 2021, respectively. The decrease in expense of$9.2 million primarily resulted from a$8.8 million reduction in the non-cash loss related to the remeasurement of the Contingent Earnout Liability as ofSeptember 30, 2022 compared toSeptember 30, 2021 and a$0.9 million increase in interest income, partially offset by a$0.4 million increase in interest expense primarily related to our loan facility withSilicon Valley Bank .
Comparison of the Nine Months Ended
Nine Months Ended September 30, Change ($ in thousands) 2022 2021 $ % Revenue $ 1,565$ 1,086 479 44 % Operating expenses: Research and development 48,303 45,091 3,212 7 % General and administrative 17,050 15,576 1,474 9 % Total operating expenses 65,353 60,667 4,686 8 % Loss from operations (63,788) (59,581) (4,207) 7 % Other income (expense), net: Change in fair value of Contingent Earnout Liability 58,649 (9,768) 68,417 * Interest expense (4,561) (2,952) (1,609) 55 % Gain on PPP loan forgiveness - 3,284 (3,284) (100) % Other income (expense), net 1,455 (45) 1,500 * Total other income (expense), net 55,543 (9,481) 65,024 * Net loss$ (8,245) $ (69,062) $ 60,817 (88) % * Not meaningful Grant Revenue For the nine months endedSeptember 30, 2022 and 2021, revenue was approximately$1.6 million and$1.1 million , respectively, and related to our grant fromDoD . The increase in revenue of$0.5 million , or 44%, relates to the timing of reimbursement of certain allowable costs related to our grant fromDoD , currently estimated to total approximately$6.8 million over the life of the grant. 37
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Research and Development Expenses
The following table discloses the breakdown of research and development expenses for the periods indicated: Nine Months Ended September 30, Change ($ in thousands) 2022 2021 $ % External services$ 12,202 $ 11,534 $ 668 6 % Materials and supplies 8,706 8,141 565 7 % Payroll and personnel expenses 18,000 17,003 997 6 % Other research and development expenses 9,395 8,413 982 12 %$ 48,303 $ 45,091 $ 3,212 7 % Research and development expenses increased from$45.1 million for the nine months endedSeptember 30, 2021 to$48.3 million for the nine months endedSeptember 30, 2022 . The increase of$3.2 million , or 7%, was primarily driven by expenses to support our expanded research and development initiatives, including (i) increased salaries and benefits of$2.2 million , (ii) a$1.0 million increase in other research and development expenses including facility maintenance, travel and software costs, (iii) a$0.7 million increase in external services including the support of clinical studies, and (iv) a$0.6 million increase in the purchase of materials and supplies to be used in the development of our commercial-scale manufacturing process and other research and development initiatives, partially offset by a$1.2 million decrease in non-cash stock compensation expense.
General and Administrative Expenses
General and administrative expenses were$17.1 million and$15.6 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase in general and administrative expenses during this period of$1.5 million , or 9%, was primarily driven by expenses associated with the transition to public company status and company growth, including (i) a$1.2 million increase in salaries and benefits and recruiting costs primarily due to higher headcount, including the initial members of the planned commercial launch team, (ii) increased professional fees of$0.7 million primarily related to increased legal and audit fees, (iii) a$0.5 million increase in insurance costs, (iv) a$0.4 million increase in external services, and (v) a$0.3 million increase in other general and administrative expenses, partially offset by a$1.7 million decrease in non-cash stock compensation expense primarily due to higher costs in 2021 resulting from restructuring of the management team to accommodate the transition to being a public company.
Total Other Income (Expense), net
Total other income, net was$55.5 million for the nine months endedSeptember 30, 2022 , compared to total other expense, net of$9.5 million for the nine months endedSeptember 30, 2021 . The increase in income of$65.0 million primarily resulted from (i) a$58.6 million non-cash gain related to the remeasurement of the Contingent Earnout Liability as ofSeptember 30, 2022 , compared to a$9.8 million non-cash loss during the nine months endedSeptember 30, 2021 , (ii) a$1.2 million increase in interest income, and (iii) a$0.2 million non-cash gain related to the remeasurement of our private placement warrant liability, partially offset by (i) a$3.3 million gain on PPP loan forgiveness we recognized during the nine months endedSeptember 30, 2021 and (ii) a$1.6 million increase in interest expense primarily related to our loan facility withSilicon Valley Bank , which commenced inMarch 2021 .
Liquidity and Capital Resources
Sources of Liquidity
To date, we have financed our operations primarily through the sale of equity securities and convertible debt, proceeds from the Merger and related PIPE Financing, borrowings under loan facilities 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 ofSeptember 30, 2022 andDecember 31, 2021 , we had an accumulated deficit of$422.8 million and$414.6 million , respectively. 38
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As ofSeptember 30, 2022 andDecember 31, 2021 , we had cash and cash equivalents and short-term investments of$171.7 million and$225.5 million , respectively. We believe our cash and cash equivalents and short-term investments will be sufficient to fund operations, including clinical trial expenses and capital expenditure requirements for at least 12 months from the date of this Quarterly Report. 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 will be satisfied through the sale of equity, debt, borrowings under credit facilities 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. As ofSeptember 30, 2022 andDecember 31, 2021 , we had working capital of$156.7 million and$218.3 million , respectively. As ofSeptember 30, 2022 , we had$30.0 million outstanding principal and$20.0 million of contingent borrowing capacity under our Loan Agreement. We do not currently have any committed external source of funds beyond the Loan Agreement.
Material Cash Requirements
Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) debt repayments (for additional information, see below and Note 7 - Debt to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report); (3) employee wages, benefits, and incentives; and (4) financing and operating lease payments (for additional information see below). 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. As ofSeptember 30, 2022 , we had non-cancellable purchase commitments of$16.8 million for supplies and services that are primarily for research and development. We have existing license agreements withDuke University andYale University and have a distribution agreement with Fresenius Medical Care. 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 atSeptember 30, 2022 . For additional information regarding our agreement with Fresenius Medical Care, and our agreements withDuke University andYale University , see Note 12 -Related Party Transactions and Note 11 - Commitments and Contingencies, respectively, to our unaudited condensed consolidated financial statements contained elsewhere in this Quarterly Report. Debt InMarch 2021 , we entered into the Loan Agreement withSilicon Valley Bank andSVB Innovation Credit Fund VIII, L.P. , as amended in June andSeptember 2021 , which provides a term loan facility of up to$50.0 million , with a maturity date ofMarch 1, 2025 . The initial term loan tranche of$20.0 million was funded upon the closing of the Loan Agreement, and onOctober 13, 2021 , we borrowed an additional$10.0 million under the Loan Agreement. The additional$20.0 million becomes accessible in two tranches of$10.0 million each contingent on the achievement of certain business and clinical development milestones. As a result of the additional borrowing inOctober 2021 , the commencement of repayment of principal was deferred until no earlier thanJuly 2023 and potentially later if the remaining tranches are drawn. As ofSeptember 30, 2022 , principal of$30.0 million was outstanding under the Loan Agreement and we were in compliance with all covenants in all material respects. Assuming no additional borrowings under the Loan Agreement, we expect to make interest payments of approximately$5.3 million under the Loan Agreement fromOctober 1, 2022 throughMarch 1, 2025 , approximately$3.1 million of which we expect to pay within one year ofSeptember 30, 2022 . Our obligations under the Loan Agreement are secured by substantially all of our assets, except for our intellectual property. The Loan Agreement contains certain customary covenants, including, but not limited to, those relating to additional indebtedness, liens, asset divestitures, and affiliate transactions. We may use the proceeds of borrowings under the Loan Agreement as working capital and to fund our general business requirements. 39
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Borrowings under the Loan Agreement bear interest at a rate of 7.5% or the sum of the Wall Street Journal Prime Rate plus 4.25%, whichever is greater (10.50% as ofSeptember 30, 2022 ). In addition, the lenders were granted warrants to purchase common stock. Interest-only payments on the principal amount outstanding are due monthly beginning in the first month after the loan is dispersed. We are required to repay principal beginning onJuly 1, 2023 , unless we draw the remaining two loan tranches, in which case repayment of the outstanding principal amount will begin no later thanApril 1, 2024 . Additionally, we are obligated to pay to the lenders a final payment fee of$1.5 million upon the maturity of the loan. Our contractual obligations under the Loan Agreement as ofSeptember 30, 2022 include$4.3 million of cash payments related to principal within one year and$25.7 million of principal payments within one to three years. InApril 2020 , we received loan proceeds in the amount of approximately$3.3 million under the PPP. The loan and accrued interest were forgivable after a 24-week period as long as we used the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintained our payroll levels. OnMay 25, 2021 , theSmall Business Administration approved the forgiveness of the outstanding amount of the PPP loan and we recognized a gain from loan extinguishment in the amount of$3.3 million during the three months endedJune 30, 2021 . Leases Our finance lease relates to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed inJune 2018 and leased throughMay 2033 , and our operating lease relates to the land lease associated with our headquarters. Our future contractual obligations under our lease agreements as ofSeptember 30, 2022 are as follows: Less than More than ($ in thousands) Total 1 year 1 - 3 years 3 - 5 years 5 years Finance leases$ 30,107 $ 3,941 $ 8,181 $ 7,433 $ 10,552 Operating leases 1,021 105 211 211 494 ATM Facility OnSeptember 1, 2022 , the Company entered into an agreement for the sale from time to time up to$80.0 million of shares of Common Stock pursuant to a sales agreement (the "ATM Facility"). As ofSeptember 30, 2022 , the Company has not conducted any sales of Common Stock under the ATM Facility.
Future Funding Requirements
We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our 6 millimeter HAV for use in vascular trauma and hemodialysis AV access and submit biologics license applications for FDA approval, (ii) if marketing approval is obtained, to launch and commercialize our HAVs for hemodialysis AV access and vascular repair in the U.S. market, including subsequent launches in key international markets, (iii) advance our pipeline in major markets, including PAD Phase III trials and continue preclinical development and advance to planned clinical studies in CABG and biovascular pancreas for diabetes, and (iv) scale out our manufacturing facility as required to satisfy potential demand if our HAVs receive marketing approval. We will need additional funding in connection with these activities.
Our future funding requirements, both short-term and long-term, will depend on many factors, including:
•the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;
•the cost, timing and outcome of regulatory review of our product candidates,
particularly for marketing approval of our HAVs in
•the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates;
•the cost and timing of our future commercialization activities, including product manufacturing, marketing and distribution for our HAVs if approved by the FDA, and any other product candidate for which we receive marketing approval in the future; 40
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•the amount and timing of revenues, if any, that we receive from commercial sales of any product candidates for which we receive marketing approval;
•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
•the costs of operating as a public company, including hiring additional
personnel as well as increased director and officer insurance premiums, audit
and legal fees, and expenses for compliance with public company reporting
requirements under the Exchange Act and rules implemented by the
Until such time, if ever, as we are able to successfully develop and commercialize one or more of our product candidates, we expect to continue financing our operations through the sale of equity, debt, borrowings under credit facilities 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 beyond the Loan Agreement. 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 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. Our principal use of cash in recent periods has been primarily to fund our operations, including the clinical and preclinical development of our product candidates. Our future capital requirements, both short-term and long-term, will depend on many factors, including the progress and results of our clinical trials and preclinical development, timing and extent of spending to support development efforts, cost and timing of future commercialization activities, and the amount and timing of revenues, if any, that we receive from commercial sales.
See the section of this Quarterly Report entitled "Risk Factors" for additional risks associated with our substantial capital requirements.
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Cash Flows
The following table shows a summary of our cash flows for each of the periods shown below: Nine Months Ended September 30, ($ in thousands) 2022 2021 Net loss $
(8,245)
(47,034) 20,686 Payment of liabilities assumed in Merger - (12,363) Changes in operating assets and liabilities: 3,109 997 Net cash used in operating activities (52,170) (59,742) Net cash used in investing activities (367) (175) Net cash (used in) provided by financing activities (1,234) 260,437 Net (decrease) increase in cash and cash equivalents$ (53,771) $ 200,520 Cash and cash equivalents at the beginning of the period$ 217,502 $ 39,929 Cash and cash equivalents at the end of the period$ 163,731 $ 240,449 ___________________________
(1) Includes depreciation, amortization related to our leases and our debt discount, stock-based compensation expense, the change in fair value of our Contingent Earnout Liability and our common stock warrant liabilities, and in 2021 includes a gain on PPP loan forgiveness.
Cash Flow from Operating Activities
The decrease in net cash used in operating activities from the nine months endedSeptember 30, 2021 to the nine months endedSeptember 30, 2022 was primarily due to$12.4 million in payments of liabilities acquired in the Merger during the nine months endedSeptember 30, 2021 , partially offset by increased spending on pre-clinical, clinical and pre-commercial activities as well as payroll and personnel expenses.
Cash Flow from Investing Activities
Net cash used in investing activities for the nine months ended
Cash Flow from Financing Activities
The decrease in net cash provided by financing activities for the nine months endedSeptember 30, 2022 was primarily due to$242.4 million of proceeds received inAugust 2021 in connection with the Merger, including proceeds from the trust account that we obtained in connection with the closing of the Merger, as well as from the PIPE Financing, along with$19.7 million of net proceeds in connection with draws under our loan facility withSilicon Valley Bank inMarch 2021 .
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any
off-balance sheet arrangements, as defined in
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles. The preparation of our unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses, and disclosure of contingent liabilities. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates based on different assumptions, judgments, or conditions. 42
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An accounting estimate or assumption is considered critical if both (a) the nature of the estimate or assumption involves a significant level of estimation uncertainty, and (b) the impact within a reasonable range of outcomes of the estimate and assumption is material to our financial condition. There have been no material changes to our critical accounting policies and estimates as compared to those disclosed in our audited consolidated financial statements as of and for the years endedDecember 31, 2021 and 2020, included in our Annual Report.
Emerging Growth Company and Smaller Reporting Company Status
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. Additionally, we are a "smaller reporting company" as defined in Item 10(f)(1) of Regulation S-K under the Exchange Act ("Regulation S-K"). Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company if (1) the market value of Common Stock held by non-affiliates is less than$250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of its second fiscal quarter are less than$100 million and the market value of Common Stock held by non-affiliates is less than$700 million as of the last business day of the second fiscal quarter.
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