Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 09, 2024 | |
Entity Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-39813 | |
Entity Registrant Name | TRISALUS LIFE SCIENCES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-3009869 | |
Entity Address, Address Line One | 6272 W 91st Ave | |
Entity Address, City or Town | Westminster | |
Entity Address, State or Province | CO | |
Entity Address, Postal Zip Code | 80031 | |
City Area Code | (888) | |
Local Phone Number | 321-5212 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,311,498 | |
Entity Central Index Key | 0001826667 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Common stock, $0.0001 par value | ||
Entity Information [Line Items] | ||
Title of 12(b) Security | Common stock, $0.0001 par value | |
Trading Symbol | TLSI | |
Security Exchange Name | NASDAQ | |
Warrants | ||
Entity Information [Line Items] | ||
Title of 12(b) Security | Warrants, each whole warrant exercisable for one share of registrant's common stock at an exercise price of $11.50 per share | |
Trading Symbol | TLSIW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 16,481 | $ 11,777 |
Accounts receivable | 4,706 | 3,554 |
Inventory | 3,443 | 2,545 |
Prepaid expenses | 3,311 | 2,986 |
Total current assets | 27,941 | 20,862 |
Property and equipment, net | 1,830 | 2,091 |
Right-of-use assets | 1,123 | 1,179 |
Intangible assets, net | 1,113 | 1,127 |
Other assets | 424 | 466 |
Total assets | 32,431 | 25,725 |
Current liabilities: | ||
Trade payables | 1,976 | 3,391 |
Accrued liabilities | 9,407 | 10,556 |
Short-term lease liabilities | 323 | 351 |
Other current liabilities | 291 | 389 |
Total current liabilities | 11,997 | 14,687 |
Long-term debt, net of unamortized discount and debt issuance costs | 21,286 | 0 |
Revenue base redemption liability | 715 | 0 |
Long-term lease liabilities | 1,154 | 1,244 |
Contingent earnout liability | 8,931 | 18,632 |
Warrant and SEPA liabilities | 12,497 | 17,100 |
Total liabilities | 56,580 | 51,663 |
Stockholders’ deficit: | ||
Preferred stock, Series A, $0.0001 par value per share, $10.00 liquidation value per share. Authorized 10,000,000 shares at June 30, 2024 and December 31, 2023, respectively; issued and outstanding, 4,015,002 shares at June 30, 2024 and December 31, 2023, respectively. | 0 | 0 |
Common stock, $0.0001 par value per share. Authorized 400,000,000 shares at June 30, 2024 and December 31, 2023, respectively; issued and outstanding, 27,159,463 and 26,413,213 shares at June 30, 2024, and December 31, 2023, respectively. | 2 | 2 |
Additional paid-in capital | 241,777 | 222,437 |
Accumulated deficit | (265,928) | (248,377) |
Total stockholders’ deficit | (24,149) | (25,938) |
Total liabilities and stockholders’ deficit | $ 32,431 | $ 25,725 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Liquidation preference (in dollars per share) | $ 10 | $ 10 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 4,015,002 | 4,015,002 |
Preferred stock, shares outstanding (in shares) | 4,015,002 | 4,015,002 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, shares issued (in shares) | 27,159,463 | 26,413,213 |
Common stock, shares outstanding (in shares) | 27,159,463 | 26,413,213 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Revenue | $ 7,364 | $ 4,612 | $ 13,821 | $ 7,596 |
Cost of goods sold | 912 | 772 | 1,883 | 1,434 |
Gross profit | 6,452 | 3,840 | 11,938 | 6,162 |
Operating expenses: | ||||
Research and development | 4,666 | 6,886 | 10,523 | 12,504 |
Sales and marketing | 6,004 | 3,492 | 12,691 | 6,741 |
General and administrative | 3,956 | 4,896 | 8,583 | 8,472 |
Loss from operations | (8,174) | (11,434) | (19,859) | (21,555) |
Other income (expense): | ||||
Interest income | 97 | 36 | 189 | 71 |
Interest expense | (877) | (4) | (880) | (9) |
Loss on equity issuance | 0 | (4,225) | 0 | (4,189) |
Extinguishment of tranche liability | 0 | 621 | 0 | 0 |
Change in fair value of SEPA, warrant, and revenue base redemption liabilities | (9,016) | 1,070 | (6,495) | 3,491 |
Change in fair value of contingent earnout liability | 13,689 | 0 | 9,701 | 0 |
Other expense, net | (44) | (25) | (197) | (43) |
Loss before income taxes | (4,325) | (13,961) | (17,541) | (22,234) |
Income tax expense | (7) | (13) | (10) | (8) |
Net loss available to common stockholders | (4,332) | (13,974) | (17,551) | (22,242) |
Deemed dividend related to Series B-2 preferred stock down round provision | 0 | (2,022) | 0 | (2,981) |
Undeclared dividends on Series A preferred stock | (801) | 0 | (1,602) | 0 |
Net loss attributable to common stockholders | $ (5,133) | $ (15,996) | $ (19,153) | $ (25,223) |
Net loss per common share, basic (in dollars per share) | $ (0.21) | $ (35.84) | $ (0.81) | $ (59.79) |
Net loss per common share, diluted (in dollars per share) | $ (0.21) | $ (35.84) | $ (0.81) | $ (59.79) |
Weighted average common shares outstanding, basic (in shares) | 23,903,659 | 446,287 | 23,613,243 | 421,861 |
Weighted average common shares outstanding, diluted (in shares) | 23,903,659 | 446,287 | 23,613,243 | 421,861 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Total | Preferred stock | Common stock | Additional paid-in capital | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 0 | ||||
Balance, beginning of period at Dec. 31, 2022 | $ (176,330) | $ 0 | $ 0 | $ 10,028 | $ (186,358) |
Balances, beginning of period (in shares) at Dec. 31, 2022 | 347,926 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of options (in shares) | 95,842 | ||||
Exercise of options | 50 | 50 | |||
Stock-based compensation | 74 | 74 | |||
Deemed dividend | 0 | 959 | (959) | ||
Net loss | (8,268) | (8,268) | |||
Ending balance (in shares) at Mar. 31, 2023 | 0 | ||||
Balance, end of period at Mar. 31, 2023 | (184,473) | $ 0 | $ 0 | 11,111 | (195,585) |
Balances, end of period (in shares) at Mar. 31, 2023 | 443,768 | ||||
Beginning balance (in shares) at Dec. 31, 2022 | 0 | ||||
Balance, beginning of period at Dec. 31, 2022 | (176,330) | $ 0 | $ 0 | 10,028 | (186,358) |
Balances, beginning of period (in shares) at Dec. 31, 2022 | 347,926 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (22,242) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 0 | ||||
Balance, end of period at Jun. 30, 2023 | (198,363) | $ 0 | $ 0 | 13,218 | (211,581) |
Balances, end of period (in shares) at Jun. 30, 2023 | 629,577 | ||||
Beginning balance (in shares) at Mar. 31, 2023 | 0 | ||||
Balance, beginning of period at Mar. 31, 2023 | (184,473) | $ 0 | $ 0 | 11,111 | (195,585) |
Balances, beginning of period (in shares) at Mar. 31, 2023 | 443,768 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of options (in shares) | 185,809 | ||||
Exercise of options | 16 | 16 | |||
Stock-based compensation | 69 | 69 | |||
Deemed dividend | 0 | 2,022 | (2,022) | ||
Net loss | (13,974) | (13,974) | |||
Ending balance (in shares) at Jun. 30, 2023 | 0 | ||||
Balance, end of period at Jun. 30, 2023 | $ (198,363) | $ 0 | $ 0 | 13,218 | (211,581) |
Balances, end of period (in shares) at Jun. 30, 2023 | 629,577 | ||||
Beginning balance (in shares) at Dec. 31, 2023 | 4,015,002 | 4,015,002 | |||
Balance, beginning of period at Dec. 31, 2023 | $ (25,938) | $ 0 | $ 2 | 222,437 | (248,377) |
Balances, beginning of period (in shares) at Dec. 31, 2023 | 26,413,213 | 26,413,213 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of options (in shares) | (4,941) | ||||
Exercise of options | $ 7 | 7 | |||
Stock-based compensation | 1,086 | 1,086 | |||
Proceeds from sale of common stock (in shares) | 350,000 | ||||
Proceeds from sale of common stock | 3,141 | 3,141 | |||
Net loss | (13,219) | (13,219) | |||
Ending balance (in shares) at Mar. 31, 2024 | 4,015,002 | ||||
Balance, end of period at Mar. 31, 2024 | $ (34,923) | $ 0 | $ 2 | 226,671 | (261,596) |
Balances, end of period (in shares) at Mar. 31, 2024 | 26,758,272 | ||||
Beginning balance (in shares) at Dec. 31, 2023 | 4,015,002 | 4,015,002 | |||
Balance, beginning of period at Dec. 31, 2023 | $ (25,938) | $ 0 | $ 2 | 222,437 | (248,377) |
Balances, beginning of period (in shares) at Dec. 31, 2023 | 26,413,213 | 26,413,213 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of options (in shares) | 927 | ||||
Net loss | $ (17,551) | ||||
Ending balance (in shares) at Jun. 30, 2024 | 4,015,002 | 4,015,002 | |||
Balance, end of period at Jun. 30, 2024 | $ (24,149) | $ 0 | $ 2 | 241,777 | (265,928) |
Balances, end of period (in shares) at Jun. 30, 2024 | 27,159,463 | 27,159,463 | |||
Beginning balance (in shares) at Mar. 31, 2024 | 4,015,002 | ||||
Balance, beginning of period at Mar. 31, 2024 | $ (34,923) | $ 0 | $ 2 | 226,671 | (261,596) |
Balances, beginning of period (in shares) at Mar. 31, 2024 | 26,758,272 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of options (in shares) | 1,191 | ||||
Exercise of options | 5 | 5 | |||
Stock-based compensation | 1,275 | 1,275 | |||
Proceeds from sale of common stock (in shares) | 400,000 | ||||
Proceeds from sale of common stock | 3,602 | 3,602 | |||
Record exchange warrants | 11,923 | 11,923 | |||
Record issuance costs | (1,699) | (1,699) | |||
Net loss | $ (4,332) | (4,332) | |||
Ending balance (in shares) at Jun. 30, 2024 | 4,015,002 | 4,015,002 | |||
Balance, end of period at Jun. 30, 2024 | $ (24,149) | $ 0 | $ 2 | $ 241,777 | $ (265,928) |
Balances, end of period (in shares) at Jun. 30, 2024 | 27,159,463 | 27,159,463 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss available to common stockholders | $ (17,551) | $ (22,242) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 382 | 334 |
Reduction in the carrying amount of right-of-use assets | 152 | 0 |
Change in fair value of warrants and SEPA liability | 6,921 | (3,491) |
Change in fair value of Initial OrbiMed Warrants and revenue base redemption liabilities | (426) | 0 |
Change in fair value of contingent earnout liability | (9,701) | 0 |
Non-cash interest expense | 151 | 0 |
Loss on equity issuance | 0 | 4,189 |
Stock-based compensation expense | 2,361 | 142 |
Loss on disposal of fixed assets | 18 | 60 |
Amortization of debt issuance costs | 267 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,152) | (537) |
Inventory, net | (899) | (51) |
Prepaid expenses | (2,025) | (266) |
Deposits | 43 | 0 |
Operating lease liabilities | (170) | 59 |
Trade payables and accrued liabilities | (2,660) | 2,064 |
Net cash used in operating activities | (24,289) | (19,739) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (126) | (38) |
Purchases of intellectual property and licenses | 0 | (66) |
Net cash used in investing activities | (126) | (104) |
Cash flows from financing activities: | ||
Proceeds from the issuance of preferred stock | 0 | 9,184 |
Proceeds from the issuance of common stock | 6,743 | 0 |
Proceeds from exercise of preferred stock warrants | 0 | 5,126 |
Debt issuance costs | (2,593) | 0 |
Proceeds from the issuance of debt | 25,000 | 0 |
Payments on finance lease liabilities | (43) | (43) |
Proceeds from the exercise of stock options for common stock | 12 | 66 |
Net cash provided by financing activities | 29,119 | 14,333 |
Increase (decrease) in cash, cash equivalents and restricted cash | 4,704 | (5,510) |
Cash, cash equivalents and restricted cash, beginning of period | 12,127 | 9,664 |
Cash, cash equivalents and restricted cash, end of period | 16,831 | 4,154 |
Supplemental disclosures of cash flow information: | ||
Fair value of warrants issued with OrbiMed debt | (811) | 0 |
Fair value of revenue base redemption liability related to OrbiMed debt | (729) | 0 |
Fair value of warrants issued with Series B-2 preferred stock | 0 | 14,701 |
Right-of-use assets obtained in exchange for new operating lease liabilities | 90 | 0 |
Transfer of warrant liability to preferred stock upon exercise of warrants | $ 0 | $ 12,082 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business On August 10, 2023 (the "Closing Date"), TriSalus Life Sciences, Inc., a Delaware corporation (the “Company,” “TriSalus,” “we,” “us”), formerly known as MedTech Acquisition Corporation (“MTAC”), consummated the previously announced merger pursuant to the Agreement and Plan of Merger, dated as of November 11, 2022, as amended by that certain First Amendment to Agreement and Plan of Merger, dated as of April 4, 2023, the Second Amendment to Agreement and Plan of Merger, dated as of May 13, 2023, and the Third Amendment to Agreement and Plan of Merger, dated as of July 5, 2023 (as amended, the “Merger Agreement”), by and between MTAC Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of MTAC (“Merger Sub”) and TriSalus Operating Life Sciences, Inc. (formerly known as TriSalus Life Sciences, Inc.), a Delaware corporation (“Legacy TriSalus”), whereby Merger Sub merged with and into Legacy TriSalus with the separate corporate existence of Merger Sub ceasing (the “Merger” and, together with the other transactions contemplated by the Merger Agreement, the “Business Combination”) and TriSalus Life Sciences, Inc. becoming the surviving company. The closing of the Business Combination is herein referred to as “the Closing.” In connection with the consummation of the Merger, on August 10, 2023, Legacy TriSalus changed its name from TriSalus Life Sciences, Inc. to TriSalus Operating Life Sciences, Inc., and MTAC changed its name from MedTech Acquisition Corporation to TriSalus Life Sciences, Inc., the surviving company ("New TriSalus”). As further described in Note (3) Business Combination , Legacy TriSalus was deemed to be the accounting acquirer and predecessor company in the Business Combination. Thus, the prior periods presented in these condensed consolidated financial statements are of Legacy TriSalus. Description of the Business We are dedicated to the research, development, and commercialization of an innovative drug delivery technology platform and an immuno-oncology therapeutic, aimed at improving outcomes for patients with difficult-to-treat liver and pancreatic cancers. Our advanced technology is designed for use by interventional radiologists to enhance the delivery of therapeutics and improve patient outcomes. We market our cutting-edge Pressure Enabled Drug Delivery (PEDD™) infusion systems, which optimize therapeutic delivery for hepatocellular carcinoma, pancreatic cancer, and other solid liver tumors. Additionally, we are developing nelitolimod, a TLR9 agonist with the potential to bolster the immune system's response. We are developing and marketing a product line — PEDD infusion systems, in use today—and we are developing a drug product candidate, nelitolimod, which has demonstrated a potential to enhance immune system response, when delivered via PEDD, in the treatment of hepatocellular cancer, pancreatic cancer and other liver solid tumors. The combination of our PEDD technology with nelitolimod is focused on solving the two main barriers in the tumor microenvironment that inhibits the success of systemic therapies. The first barrier (mechanical) is comprised of high intratumoral pressure within tumors that limits drug uptake and the second barrier (biological) is the reversal of intratumoral immunosuppression. Our PEDD with SmartValve™ is the only technology designed to work in synchrony with the cardiac cycle to open collapsed vessels in the tumor to enable deeper perfusion and improve therapeutic drug delivery in tumors with high intratumoral pressure. PEDD with SmartValve has been shown in prospective and retrospective clinical studies and in multiple pre-clinical models to improve therapy uptake and tumor response. nelitolimod has a dual mechanism of action in solid tumors which includes the alteration of the tumor microenvironment by reducing immunosuppressive myeloid derived suppressor cells while simultaneously activating immune response and recruiting T-cells to the tumor, allowing checkpoint inhibitors to work more effectively. TriNav™ is the newest therapy delivery device with SmartValve technology for the proprietary PEDD approach. Current sales consist of the TriNav Infusion System, introduced in 2020, and a family of related guiding catheters. In 2020, we gained transitional pass-through payments (“TPT”) approval from the Centers for Medicare & Medicaid Services (“CMS”), which allows hospitals to cover the cost of using TriNav. The approval expired at the end of 2023. On June 1, 2023, we applied for a new technology APC code with CMS. In December 2023, CMS granted a New Technology Healthcare Common Procedure Coding System ("HCPCS") code for both mapping and therapeutic procedures involving TriNav. This new code, HCPCS C9797, has been assigned to the Ambulatory Payment Classification ("APC") code 5194 - Level 4 Endovascular procedures. The new code became effective on January 1, 2024, and may be reported by hospital outpatient departments and ambulatory surgical centers. We believe the full potential of our technology can be realized through the combination of our drug delivery technology with immune-oncology drugs. In July 2020, we acquired our first immune-oncology drug, nelitolimod, and began clinical development of nelitolimod for treatment of liver and pancreatic cancers. We have funded operations to date principally with proceeds from the sale of preferred stock, from the issuance of debt and convertible debt, and the closing of the Business Combination. Since inception of the Company in 2009 through June 30, 2024, we have issued for cash $164,364 of preferred stock (of which $36,854 was raised at the closing of the Business Combination, including issuance of Series A convertible preferred stock), which, along with $7,315 from common stock and $57,466 from convertible notes and warrants, has funded our accumulated deficit of $265,928. During the six months ended June 30, 2024, we raised $6,743 in cash through the sale of common stock under the Standby Equity Purchase Agreement, which we entered into with YA II PN, Ltd. ("Yorkville") on October 2, 2023 (the "SEPA") and $12 from the exercise of stock options. See Note (13) Standby Equity Purchase Agreement for discussion of the SEPA. On April 30, 2024 (the "OrbiMed Closing Date"), we entered into a Credit Agreement (the "Credit Agreement") with OrbiMed Royalty & Credit Opportunities IV, LP ("OrbiMed"), a healthcare investment firm. Under the terms of the Credit Agreement, we may borrow up to $50,000, of which we immediately drew $25,000, before expenses. The remaining debt is available in two increments of $10,000 and $15,000, subject to the achievement of certain revenue targets. See Note (14) Debt for further discussion. As of June 30, 2024, we had cash, cash equivalents, and restricted cash of $16,831. The Company is still in its early stage, has a history of recurring operating losses, has yet to generate revenues sufficient to create positive cash flow and has an accumulated deficit of $265,928 as of June 30, 2024. We expect that our existing cash and cash equivalents will not be sufficient to fund our projected liquidity requirements for the next 12 months from the issuance date of the financial statements. If we are able to achieve certain targets specified in the Credit Agreement and are then able to draw the remainder of the funds available, and if market conditions allow us to sell additional shares under the SEPA, we believe we can fund our operations through the end of 2025. In accordance with ASC Topic 205-40, Presentation of Financial Statements, Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , we are required to evaluate whether there is substantial doubt about our ability to continue as a going concern each reporting period. In evaluating our ability to continue as a going concern, management projected our cash flow sources and needs and evaluated the conditions and events that could raise substantial doubt about our ability to continue as a going concern within one year after the date that these condensed consolidated financial statements were issued. Management’s plans to address the conditions and events have considered our current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of these condensed consolidated financial statements as to whether we have the ability to fund future operations and meet our obligations as they become due in the normal course of business. Our ability to fund future operations and to continue the execution of our long-term business plan and strategy, including our transformation into a therapeutics company, will require that we raise additional capital through a combination of collaborations, strategic alliances and licensing arrangements, and issuance of additional equity and/or debt. As described in Note (13) Standby Equity Purchase Agreement , we have the right but not the obligation to sell up to $30,000 of our Common Stock at our request under the SEPA, subject to terms and conditions specified in the agreement. During the six months ended June 30, 2024, we sold 750,000 shares of common stock under the SEPA, raising $6,743. In addition, as described in Note (14) Debt , in April 2024, we entered into a secured loan for up to $50,000, of which we immediately drew $25,000, before expenses. Outside of these agreements, there can be no assurance that we will be able to raise such additional financing or, if available, that such financing can be obtained on satisfactory terms. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring clinical trials and capital expenditures, and reducing other operating costs. Our current operating plan, which is in part determined based on our most recent results and trends, along with the items noted above, causes substantial doubt to exist about our ability to continue as a going concern and management’s plans do not alleviate the existence of substantial doubt. Our financial statements have been prepared assuming we will continue as a going concern, which contemplates the continuity of normal business activities and realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments that might be necessary should we be unable to continue as a going concern. We are subject to various risks and uncertainties frequently encountered by companies in the early stages of growth, particularly companies in the rapidly evolving market for medical technology-based and pharmaceutical products and services. Such risks and uncertainties include, but are not limited to, a limited operating history, need for additional capital, a volatile business and technological environment, the process to test and obtain approval to market the candidate pharmaceutical, an evolving business model, and demand for our products. To address these risks, we must, among other things, gain access to capital in sufficient amounts and on acceptable terms, maintain and increase our customer base, implement and successfully execute our business strategy, develop the candidate pharmaceutical, continue to enhance our technology, provide superior customer service, and attract, retain, and motivate qualified personnel. There can be no guarantee that we will succeed in addressing such risks. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The interim unaudited condensed consolidated financial statements are comprised of the financial statements of the Company. In management’s opinion, the interim financial data presented includes all adjustments necessary for a fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2024. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2023. The December 31, 2023, condensed consolidated balance sheet is derived from the audited balance sheet included in the Annual Report on Form 10-K for the year ended December 31, 2023. A summary of our significant accounting policies is included in Note 2 to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023. Certain of our accounting policies are considered critical, as these policies are the most important to the depiction of our financial statements and require significant, difficult or complex judgments by us, often employing the use of estimates about the effects of matters that are inherently uncertain. Such policies are summarized below. We have modified the presentation of certain warrants. In previous filings, we reported the Working Capital Warrants in combination with the Private Warrants, calling them collectively the Private Warrants. For the current Quarterly Report on Form 10-Q, we have separated the Working Capital Warrants from the Private Placement Warrants. (a) Warrants Liabilities Freestanding financial instruments that permit the holder to acquire shares that are either puttable by the holder, redeemable or contingently redeemable are required to be reported as liabilities in the financial statements. We present such liabilities on the balance sheets at their estimated fair values. Changes in fair value of the liability are calculated each reporting period, and any change in value are recognized in the condensed consolidated statements of operations. In connection with the Business Combination, we assumed warrants to purchase common stock. The warrants include the Public Warrants, Private Placement Warrants and Working Capital Warrants. We value the liability for both sets of warrants based on the trading price of the publicly held warrants. See Note (10) Warrants and (4) Financial Instruments for further discussion. In connection with the $25,000 funded amount on the OrbiMed Closing Date (the "Initial OrbiMed Loan"), we issued the Initial OrbiMed Warrant, which we classified as a derivative liability due to failure to meet the equity classification criteria under ASC 815-40. We calculated the fair value of the Initial OrbiMed Warrant based on the Black-Scholes-Merton option pricing model. This model considers several variables and assumptions in estimating the fair value of financial instruments, including the per-share fair value of the underlying common stock, exercise price, expected term, risk-free interest rate, expected stock price volatility over the expected term, and expected annual dividend yield. We calculated the expected terms as the contractual expiration period. The risk-free interest rate is estimated using the rate of return on U.S. treasury notes with a life that approximates the expected term. Our common stock does not have sufficient trading history and, therefore, we used the historical volatility of the stock prices of similar publicly traded peer companies. We utilized a dividend yield of zero, as we have no history or plan of declaring dividends on the Company's common stock. (b) Revenue Base Redemption Liability We determined that we should bifurcate and separately recognize the Revenue Base Redemption Feature (see Note (14) Debt for further detail). We determined the value of the Revenue Base Redemption Feature using a Monte Carlo simulation of future revenue and valuing the Initial Term Loan using the with and without method. (c) Contingent Earnout Liability In connection with the execution of the Merger Agreement, MTAC entered into a sponsor support agreement (the “Sponsor Support Agreement”) with MedTech Acquisition Sponsor LLC (the "Sponsor”), Legacy TriSalus and MTAC’s directors and officers (the Sponsor and MTAC’s directors and officers, collectively, the “Sponsor Holders”). Pursuant to the Sponsor Support Agreement, 3,125,000 shares of common stock in the Company ("Common Stock") held by the Sponsor Holders immediately after the Closing Date (such shares, the “Sponsor Earnout Shares”) became unvested and subject to potential forfeiture if certain triggering events are not achieved prior to the 5th anniversary of the Closing Date (the “Earnout Period”). The Sponsor Earnout Shares are classified as a liability in the Company’s condensed consolidated balance sheets because they do not qualify as being indexed to the Company’s own stock. The earnout liability was initially measured at fair value at the Closing Date and is subsequently remeasured at the end of each reporting period. The change in fair value of the earnout liability is recorded in the condensed consolidated statements of operations. See Notes (9) Contingent Earnout Liability and (4) Financial Instruments and for further detail. (d) Standby Equity Purchase Agreement In October 2023, we entered into the SEPA with Yorkville. Pursuant to the SEPA, we have the right, but not the obligation, to sell to Yorkville up to $30 million of shares of Common Stock at our request at any time during the 24 months following the execution of the SEPA, subject to certain conditions. We evaluated the contract that includes the right to require Yorkville to purchase shares of common stock in the future (“put right”) considering the guidance in ASC 815-40, Derivatives and Hedging — Contracts on an Entity’s Own Equity and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting. Each period, we analyze the terms of the freestanding put right and record the balance as a liability. Changes in the fair value are recognized in earnings. (e) Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ significantly from those estimates. The most significant estimates relate to the valuation of earnout, warrant and tranche liabilities, and the valuation allowance on deferred tax assets. (f) Research and Development Research and development (“R&D”) costs include our engineering, regulatory, pre-clinical and clinical activities. R&D costs are expensed as incurred. We are required to estimate our expenses resulting from our obligations under agreements with vendors, consultants, and contract research organizations, in connection with conducting R&D activities. The financial terms of these contracts are subject to negotiations, which vary from agreement to agreement and may result in payment flows that do not match the periods over which goods or services are provided. We reflect R&D expenses in our condensed consolidated financial statements by matching those expenses with the period in which services and efforts are expended. We account for these expenses according to the progress of the agreements, along with the preparation of financial models, taking into account discussions with research and other key personnel as to the progress of studies or other services being performed. To date, we have had no material differences between our estimates of such expenses and the amounts actually incurred. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods are consumed or services are performed Recently Adopted Accounting Pronouncements In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions , which clarifies the guidance on ASC Topic 820 on the fair value measurement of equity security that is subject to a contractual sale restriction and requires specific disclosures related to such an equity security. Specifically, the ASU clarifies that a "contractual sale restriction prohibiting the sale of an equity security is a characteristic of the reporting entity holding the equity security and is not included in the equity security's unit of account." As such, the entity should not apply a discount related to the contractual sale restriction when measuring the equity security's fair value. In addition, the ASU prohibits an entity from recognizing a contractual sale restriction as a separate unit of account. For public companies, the amendments for this update are effective for fiscal years beginning after December 15, 2023. For all other entities, the amendments are effective for fiscal year beginning after December 15, 2024, and interim periods within those fiscal years. We adopted ASU 2022-03 on January 1, 2024. The effect of the adoption had an immaterial impact on our condensed consolidated financial statements. In November 2023, the FASB issued ASU 2023-07, Improvements to Disclosures About Reportable Segments . The ASU improves reportable segment disclosure requirements through enhanced disclosures about significant segment expenses in annual and interim reports, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, add disclosure requirements for entities with a single reportable segment, and other enhancements. The ASU is effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We adopted ASU 2023-07 on January 1, 2024. The effect of the adoption had no impact on our condensed consolidated financial statements. Accounting Pronouncements Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures . Under the ASU, Public Business Entity ("PBE") must annually "(1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate)." This guidance is effective for public companies for annual periods beginning after December 15, 2024. For other companies, the amendments are effective for annual periods beginning after December 15, 2025. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements. In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, which clarifies the guidance on ASC Topic 718 by illustrating how to apply the scope guidance to determine whether a profit interest award should be accounted for as a shared-based payment arrangement under ASC 718 or another accounting standard (e.g., employee profit-sharing arrangement under ASC 710). The ASU aims to reduce the complexity diversity in practice by adding an example to ASC 718 that describes four fact patterns and illustrates how an entity evaluates common terms and characteristics of profit interests and similar awards to reach a conclusion about whether an award meets the scope conditions in ASC 718-10-15-3. The ASU is effective for all public entities for fiscal years beginning after December 15, 2024 and interim periods within those fiscal years. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements. In March 2024, the FASB issued ASU 2024-02, Codification Improvements — Amendments to Remove References to the Concept Statements, |
Business Combination
Business Combination | 6 Months Ended |
Jun. 30, 2024 | |
Reverse Recapitalization [Abstract] | |
Business Combination | Business Combination On August 10, 2023, we consummated the previously announced merger pursuant to the Merger Agreement by and among MTAC, Merger Sub, Inc., and TriSalus Life Sciences, Inc. Upon the closing of the transactions contemplated by the Merger Agreement, Merger Sub merged with and into Legacy TriSalus (the “Business Combination”) with Legacy TriSalus surviving the merger as a wholly owned subsidiary of MTAC, renamed “TriSalus Operating Life Sciences, Inc.” In addition, in connection with the consummation of the Business Combination, MTAC was renamed “TriSalus Life Sciences, Inc.” Immediately prior to the effective time of the Business Combination, each in-the-money warrant of Legacy TriSalus that was unexercised and unexpired was automatically net exercised into the respective series of preferred stock of Legacy TriSalus. Each share of preferred stock of Legacy TriSalus (“Legacy TriSalus Preferred Stock”) that was issued and outstanding was then automatically converted into shares of common stock of Legacy TriSalus (“Legacy TriSalus Common Stock”) in accordance with the Amended and Restated Certificate of Incorporation of Legacy TriSalus at the then current conversion price, such that each converted share of Legacy TriSalus Preferred Stock was no longer outstanding and ceased to exist, and each holder of Legacy TriSalus Preferred Stock thereafter ceased to have any rights with respect to such securities. Proceeds from this transaction totaled $42,854. These proceeds were comprised of $2,704 from the MTAC trust account, and $40,150 received from the assumption of a concurrent private investment in public equity financing (“PIPE Financing”). Pursuant to the terms of the Merger Agreement, $6,000 of the proceeds were used to pay expenses incurred by MTAC related to the merger, resulting in net cash proceeds of $36,854. The Company incurred $6,069 in transaction costs relating to the merger with MTAC, of which $1,742 was recorded as a reduction of equity and the balance of $4,327 was recorded in general and administrative expense. Pursuant to the terms of the Merger Agreement, the existing stockholders of Legacy TriSalus exchanged their equity holdings at an exchange ratio of 0.02471853 (the “Exchange Ratio”) for an aggregate of 21,999,886 shares of our Common Stock. In addition, MTAC had previously issued public warrants and private placement warrants (collectively, the “MTAC Warrants”) as part of its initial public offering in November 2020. None of the terms of the MTAC Warrants were modified as a result of the Business Combination. See Note (10) Warrants |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments | Financial Instruments Our financial instruments consist of cash, cash equivalents, accounts receivable, trade payables, contingent earnout liability, and warrants to purchase preferred and common stock. The carrying values of these financial instruments (other than warrants and tranche and earnout liabilities, which are held at fair value) approximate fair value at June 30, 2024, and December 31, 2023. In general, asset and liability fair values are determined using the following categories: Level 1 — Inputs utilize quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs include quoted prices for similar assets or liabilities in active markets, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. Level 3 — Inputs are unobservable inputs and include situations where there is little, if any, market activity for the balance sheet items at period end. Pricing inputs are unobservable for the terms and are based on the Company’s own assumptions about the assumptions that a market participant would use. Our warrant, earnout liabilities, SEPA, tranche, and revenue redemption feature are measured at fair value on a recurring basis. At the Closing Date, we assumed warrants to purchase 14,266,605 shares of common stock for $11.50 (see Note (10) Warrants ). Of these, 8,333,272 were traded publicly (the "Public Warrants"), 5,933,333 were privately held (the 4,933,333 "Private Placement Warrants" and 1,000,000 "Working Capital Warrants" and together with the Public Warrants, the "SPAC Warrants"). At the Closing Date, we determined the fair value of all the SPAC warrants to be $2,568 based on the closing price of $0.18 for the Public Warrants (Level 1). At the Closing Date, we determined the fair value of the earnout liability to be $28,927 based on a Monte Carlo simulation of future trading prices for our common stock. See Note (9) Contingent Earnout Liability for further discussion. The carrying amount of our outstanding SPAC warrants liabilities was $11,705 at June 30, 2024. The carrying amount of outstanding earnout liability was $8,931 at June 30, 2024. The carrying amount of the outstanding SEPA derivative liability was $394 at June 30, 2024. The carrying values of the warrant liabilities represent the remeasurement to fair value each reporting period based on Level 1 inputs for the publicly traded Public Warrants and Level 2 inputs for the Private Placement Warrants and Working Capital Warrants. The carrying amounts of the contingent earnout liability and SEPA derivative liability represent the remeasurement to fair value each reporting period based on unobservable, or Level 3, inputs, using assumptions made by us, including the market price of our common stock and the observed volatility of a peer group of companies. On October 2, 2023, we entered into the SEPA with Yorkville. Upon execution of the SEPA, we determined the fair value of the SEPA derivative liability to be $183 based on a scenario-based model. See Note (13) Standby Equity Purchase Agreement for further discussion. We determined the fair value of the SEPA derivative liability to be $394 at June 30, 2024; we recorded the change in fair value in other income and expense, net. In connection with the closing of the OrbiMed Credit Agreement on April 30, 2024, we also issued OrbiMed a warrant to purchase 130,805 shares of our common stock, with an exercise price of $9.5562 (the "Initial OrbiMed Warrant"). The Initial OrbiMed Warrant expires on April 30, 2031 (see Notes (10) Warrants and (14) Debt for more information on the OrbiMed Credit Agreement). The Initial OrbiMed Warrant is accounted for as a liability under ASC 815, Derivatives and Hedging, Contracts in Equity's Own Equity ("ASC 815-40"), as it provides settled provision that does not meet the requirements of the indexation guidance under ASC 815-40. On May 24, 2024, we commenced an offer (the “Offer”) to all holders of Public Warrants, Private Placement Warrants and Working Capital Warrants (collectively, the "Exchange Warrants") to receive 0.30 shares of common stock of the Company in exchange for each Exchange Warrant tendered by the holder and exchanged pursuant to the Offer. The Offer expired at one minute after 11:59 p.m., Eastern Standard Time, on June 25, 2024. The Exchange Warrants tendered were comprised of 6,529,954 Public Warrants and 504,685 Private Placement Warrants. We determined the Exchange Warrants met the criteria to be equity classified at June 26, 2024, and that their fair value was $11,924. Accordingly, we recorded that amount as a reduction of the warrant liability and a charge to APIC. The Initial OrbiMed Warrant was measured at fair value at inception and is subsequently measured at fair value on a recurring basis, with changes in fair value recognized in other income (expense) within the Company's condensed statement of operations. We use a Black-Scholes option pricing model to estimate the fair value of the Initial OrbiMed Warrant, which utilizes certain unobservable inputs and is therefore considered a Level 3 fair value measurement. Certain inputs used in this Black-Scholes pricing model may fluctuate in future periods based upon factors that are outside of the Company's control, including potential change in control outside of the Company's control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company's warrant liabilities, which could also result in material non-cash gains or losses being reported in the Company's condensed statement of operations. The following tables summarize the changes in fair value of our outstanding warrant liabilities, Exchange Warrants, contingent earnout liability, SEPA derivative liability, and revenue base redemption liability for the six months ended June 30, 2024 and 2023. Warrant Liabilities Fair Value at Change in Issuances Fair Value at Public Warrants - Level 1 $ 9,855 $ 4,068 $ (11,068) $ 2,855 Private Placement Warrants - Level 2 5,871 2,204 (855) 7,220 Working Capital Warrants - Level 2 1,190 440 — 1,630 Total $ 16,916 $ 6,712 $ (11,923) $ 11,705 Exchange Warrants Fair Value at Change in Issuances Fair Value at Exchange Warrants (Equity-Classified) - Level 2 $ — $ — $ 11,923 $ 11,923 Level 3 Fair Value at Change in Issuances Fair Value at Contingent earnout liability $ 18,632 $ (9,701) $ — $ 8,931 SEPA derivative liability $ 185 $ 209 $ — $ 394 Initial OrbiMed Warrant liability $ — $ (413) $ 811 $ 399 Revenue base redemption liability $ — $ (13) $ 729 $ 715 Level 3 Fair Value at Change in Issuances Net Transfer Fair Value at Warrant liabilities $ 369 $ (1) $ (106) $ — $ 262 Series B-2 tranche liabilities $ 4,702 $ (2,241) $ (1,502) $ — $ 959 Series B-3 warrant liabilities $ 15,819 $ (1,248) $ 2,619 $ — $ 17,190 |
Cash, Cash Equivalents and Rest
Cash, Cash Equivalents and Restricted Cash | 6 Months Ended |
Jun. 30, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash, as presented in the Condensed Consolidated Statements of Cash Flows, consisted of the following: June 30, December 31, Cash and cash equivalents $ 16,481 $ 11,777 Restricted cash (included in Other assets) 350 350 Total cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 16,831 $ 12,127 Restricted cash of $350 is held by our bank to support our corporate credit card program. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of inventory are summarized as follows: June 30, December 31, Raw materials $ 901 $ 607 Finished goods 2,542 2,055 Reserve for obsolete inventory — (117) Inventory $ 3,443 $ 2,545 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets Intangible assets consist entirely of patent costs that provide the Company with rights, titles, and interests in the development of certain processes, discoveries, and inventions with the right to commercialize that are probable of future economic benefits. Patent costs associated with pharmaceutical intellectual property are expensed as incurred as future economic benefits are not deemed to be probable. Intangible assets are recorded at cost and are amortized over the estimated life of the patents, based on the approval and expiration dates applicable to each patent — typically 20 years — on a straight-line basis. Amortization expense related to intellectual property for six months ended June 30, 2024 and 2023 was $13 and $22, respectively. The estimated aggregate amortization expense for intangible assets subject to amortization for each of the five succeeding fiscal years is as follows: 2024 $ 25 2025 51 2026 51 2027 51 2028 51 Thereafter 884 $ 1,113 |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued Liabilities consists of the following: June 30, December 31, Accrued liabilities - clinical trials $ 3,706 $ 3,115 Accrued liabilities 2,763 2,790 Accrued bonus 1,664 3,736 Accrued vacation 351 327 Accrued payroll 386 557 Accrued employee benefits 500 — Accrued taxes 37 31 Total accrued liabilities $ 9,407 $ 10,556 |
Contingent Earnout Liability
Contingent Earnout Liability | 6 Months Ended |
Jun. 30, 2024 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Contingent Earnout Liability | Contingent Earnout Liability In connection with the execution of the Merger Agreement (see Note (3) Business Combination) , MTAC entered into the Sponsor Support Agreement. Pursuant to the Sponsor Support Agreement, the 3,125,000 Sponsor Earnout Shares became unvested and subject to potential forfeiture if certain triggering events are not achieved prior to the 5 th anniversary of the Closing Date. Pursuant to the Sponsor Support Agreement, (i) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $15.00 for any 20 trading days within a period of 30 consecutive trading days, (ii) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $20.00 for any 20 trading days within a period of 30 consecutive trading days, (iii) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $25.00 for any 20 trading days within a period of 30 consecutive trading days; and (iv) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $30.00 for any 20 trading days within a period of 30 consecutive trading days. Additionally, the Sponsor Earnout Shares will vest if there is a change in control of our company on or before the 5 th anniversary of the Closing Date that results in the holders of our Common Stock receiving a price per share equal to or in excess of the applicable earnout targets. Any such shares held by the Sponsor Holders that remain unvested after the 5 th anniversary of the Closing will be forfeited. The estimated fair value of the contingent earnout liability at the closing on August 10, 2023, was $28,927 based on a Monte Carlo simulation valuation model. The liability was remeasured to its fair value of $18,632 and $8,931 as of December 31, 2023 and June 30, 2024, respectively. This remeasurement resulted in the recording of a gain of $13,689 and $9,701 for the three and six months ended June 30, 2024, respectively, classified as change in fair value of contingent earnout liability in the Condensed Consolidated Statements of Operations. Assumptions used in the valuation are described below: June 30, December 31, Current stock price $ 5.52 $ 8.45 Expected share price volatility 65.0 % 65.0 % Risk-free interest rate 4.4 % 3.9 % Expected term (years) 4.11 4.60 Estimated dividend yield — % — % The estimated fair value of the liability was determined using a Monte Carlo simulation valuation model using a distribution of potential outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including: (a) expected volatility, which is based on the historical equity volatility of publicly traded peer companies for a term equal to the expected term of the earnout period; (b) expected term, which we based on the earnout period per the agreement; (c) risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the earnout period; and (d) expected dividend yield, which we estimate to be 0% based on the fact that we have never paid or declared dividends. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision. In October 2023, we entered into the SEPA with Yorkville. Yorkville is a fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company shall have the right, but not the obligation, to sell to Yorkville up to $30.0 million of Common Stock, par value $0.0001 per share, at the Company’s request any time during the commitment period commencing on October 2, 2023 (the “Effective Date”), and terminating on the first day of the month following the 24-month anniversary of the Effective Date. Each issuance and sale by the Company to Yorkville under the SEPA (an “Advance”) is subject to a maximum limit equal to the greater of: (i) an amount equal to 100% of the average of the daily volume of the Common Stock on the Nasdaq Stock Market (“Nasdaq”) for the 10 trading days immediately preceding an Advance notice, or (ii) 1,000,000 shares of Common Stock. At the election of the Company, the shares will be issued and sold to Yorkville at a per-share price equal to: (i) 96.0% of the Market Price (as defined below) for any period commencing on the receipt of the Advance notice by Yorkville and ending on 4:00 p.m. New York City time on the applicable Advance notice date (the “Option 1 Pricing Period”), or (ii) 97.0% of the Market Price for any three As described in Note (2) Summary of Significant Accounting Policies , the SEPA is accounted for as a derivative and is recognized as a liability measured at fair value in accordance with ASC 820. The Company intends to utilize the SEPA to access capital to fund its operations. The Company did not issue any Advances during the year ended December 31, 2023. The estimated fair value of the SEPA liability on December 31, 2023, was $185, which was determined using a scenario-based valuation model. The liability was remeasured to its fair value of $394 as of June 30, 2024, and is classified within other long-term liabilities in the Condensed Consolidated Balance Sheets. This remeasurement resulted in the recognition of a loss of $209 for six months ended June 30, 2024, classified as change in fair value of SEPA, tranche and warrant liabilities in the Condensed Consolidated Statement of Operations. Assumptions used in the valuation are described below: Valuation assumptions: June 30, 2024 December 31, 2023 Expected draws $ 13,000 $ 5,000 Expected probability of draws 90% - 100% 90 % Risk-free interest rate 5.5 % 5.4 % The estimated fair value of the liability was determined using a scenario-based valuation model which assigned a probability to a number of different outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including: (a) total expected draws of $13,000 and $5,000, at June 30, 2024, and December 31, 2023, respectively, through the issuance of multiple separate advances under the Option 2 Pricing Period at June 30, 2024, and Option 1 Pricing Period at December 31, 2023; (b) the expected probability of the draws on the SEPA, which we estimate based on our expectation of the draws being completed; and (c) risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the agreement in relation to the date of the expected draw. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2024 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants Warrants that have not been tendered for exchange and outstanding at June 30, 2024, and December 31, 2023, are as follows: June 30, December 31, Public Warrants 1,751,825 8,281,779 Private Placement Warrants 4,428,648 4,933,333 Working Capital Warrants 1,000,000 1,000,000 Initial OrbiMed Warrant 130,805 — Exchange Warrants (Equity-Classified) 7,034,639 — Total warrants 14,345,917 14,215,112 Public, Private Placement and Working Capital Warrant Liabilities In connection with consummation of the Business Combination, we assumed the warrant liabilities associated with 8,333,272 Public Warrants. Each Public Warrant is exercisable to purchase one share of common stock at a price of $11.50 per share, subject to adjustment. Under a plan approved by the Board, we repurchased 51,493 Public Warrants for $20 during the fourth quarter of 2023. The purchase plan was discontinued in December 2023. The Public Warrants expire 5 years after the completion of the Business Combination or earlier upon redemption or liquidation. We may redeem for cash the outstanding Public Warrants: a. in whole and not in part; b. at a price of $0.01 per Public Warrant; c. upon not less than 30 days’ prior written notice of redemption to each warrant holder; and d. if, and only if, the reported closing price of the Common Stock equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading day period ending three business days before the Company sends the notice of redemption to the warrant holders. If and when the SPAC Warrants become redeemable by the Company, we may exercise its redemption right even if it is unable to register or qualify the underlying securities for sale under all applicable state securities laws. If we call the Public Warrants for redemption, management will have the option to require all holders that wish to exercise the Public Warrants to do so on a “cashless basis.” The exercise price and number of shares of common stock issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, or recapitalization, reorganization, merger or consolidation. However, except as described below, the warrants will not be adjusted for issuances of common stock at a price below its exercise price. Additionally, in no event will the Company be required to net cash settle the warrants. Accordingly, the warrants may expire worthless. In addition to the Public Warrants, we assumed the warrant liabilities associated with 4,933,333 Private Placement Warrants and 1,000,000 Working Capital Warrants. The Private Placement Warrants and Working Capital Warrants are identical to the Public Warrants, except that the Private Placement Warrants and Working Capital Warrants, and the common stock issuable upon the exercise of the Private Placement Warrants and Working Capital Warrants, were not transferable, assignable or saleable until 30 days after the completion of the Business Combination, subject to certain limited exceptions. Additionally, the Private Placement Warrants and Working Capital Warrants are exercisable on a cashless basis and are non-redeemable so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants and Working Capital Warrants are held by someone other than the initial purchasers or their permitted transferees, they will be redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants. As of June 30, 2024, there were 4,933,333 Private Placement Warrants and 1,000,000 Working Capital Warrants outstanding. We determined that the Public Warrants, Private Placement Warrants, and Working Capital Warrants do not meet the criteria to be equity classified and should be recorded as liabilities. Our analysis concluded liability classification under ASC 815, Derivatives and Hedging , as these warrants include a provision that could allow cash settlement upon an event outside the control of the Company, and such event may not result in a change in control of the Company. As a result, the Private and Public Warrants do not meet the criteria for equity classification. At the close of the Business Combination, the fair values of the Public Warrants, Private Placement Warrants, and Working Capital Warrants were $1,500, $888, and $180, respectively. As of June 30, 2024, the fair values of the Public Warrants, Private Placement Warrants and Working Capital Warrants were $2,855, $7,219, and $1,630, respectively. The fair value of the Public Warrants has been measured based on the quoted price of such warrants on the Nasdaq Global Market. The transfer of Private Placement Warrants or Working Capital Warrants to anyone outside of a small group of individuals who are permitted transferees would result in the Private Placement Warrants and Working Capital Warrants having substantially the same terms as the Public Warrants. Therefore, we determined that the fair value of each Private Warrant and Working Capital Warrant is equivalent to that of each Public Warrant. On May 24, 2024, we commenced (i) the Offer and (ii) the solicitation of consent (the “Consent Solicitation”) from holders of the Exchange Warrants to amend the Warrant Agreement, dated as of December 17, 2020 (the “Warrant Agreement” and such amendment, the “Warrant Amendment”), by and between the Company and Continental Stock Transfer & Trust Company, which governs all of the Exchange Warrants. The Warrant Amendment, to the extent approved by the requisite holders of each applicable class of Exchange Warrant, provides the Company the right to force the conversion of each Exchange Warrant subject to the Warrant Amendment into 0.27 shares of common stock of the Company. The Offer and Consent Solicitation expired at one minute after 11:59 p.m., Eastern Standard Time, on June 25, 2024. The Exchange Warrants tendered were comprised of 6,529,954 Public Warrants and 504,685 Private Placement Warrants, which represents approximately 78.8% and 10.2% of the outstanding warrants of each respective class. The Warrants were validly tendered and not validly withdrawn prior to the expiration of the Offer and Consent Solicitation. No Working Capital Warrants were tendered. We determined the Exchange Warrants met the criteria to be equity classified at June 26, 2024, and that their fair value was $11,924. Accordingly, we recorded that amount as a reduction of the warrant liability and a charge to APIC, partially offset by issuance costs of $1,699. On July 1, 2024, we issued 2,110,366 shares of common stock in exchange for the Exchange Warrants. The following table summarizes activity in the Public Warrants, Private Placement Warrants, Working Capital Warrants and Exchange Warrants in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Exercises Issuances Retirements / Conversions Balance at Public Warrants 8,281,779 — — (6,529,954) 1,751,825 Private Placement Warrants 4,933,333 — — (504,685) 4,428,648 Working Capital Warrants 1,000,000 — — — 1,000,000 Exchange Warrants (Equity-Classified) — — — 7,034,639 7,034,639 Initial OrbiMed Warrant In connection with the closing of the OrbiMed Credit Agreement, we also issued OrbiMed the Initial OrbiMed Warrant to purchase 130,805 shares of our common stock (the "Warrant Shares"), with an exercise price of $9.5562, (the "Exercise Price"). The Initial OrbiMed Warrant expires on April 30, 2031 (the "Expiration Date"). On each of the closings of the Delayed Draw Commitment Amounts, if any, we agreed to issue additional warrants to purchase a number of shares of our common stock determined by dividing 5.0% of the applicable Delayed Draw Commitment Amount by the 10-day volume weighted average sale price of our common stock as of the issue date (the “Subsequent OrbiMed Warrants” and collectively, with the Initial OrbiMed Warrant, the “OrbiMed Warrants” and together with the SPAC Warrants, the “Warrants”). The Subsequent Warrants will expire seven years from each applicable issuance date, if any. In connection with the OrbiMed Warrants, we entered into a Registration Rights Agreement with OrbiMed (the “OrbiMed Registration Rights Agreement”), whereby OrbiMed will have certain customary registration rights with respect to the shares of common stock underlying the OrbiMed Warrants. The Initial OrbiMed Warrant may be exercised in whole or in part, at any time prior to the Expiration Date (the "Exercise Period"), by either: a. making a payment to the Company, in an amount in immediately available funds equal to the aggregate Exercise Price to be paid upon the exercise of the Initial OrbiMed Warrant; or b. instructing the Company to withhold a number of Warrant Shares then issuable upon exercise of the Initial OrbiMed Warrant with an aggregate fair market value as of the exercise date equal to such aggregate Exercise Price to be paid upon the exercise of the Initial OrbiMed Warrant (the “Cashless Exercise”). If either upon (i) the occurrence of the Expiration Date, or (ii) the date on which a Sale of the Company (defined in the Initial OrbiMed Warrant) is consummated pursuant to which the sole consideration payable to the Company or its stockholders in respect of such sale transaction consists of cash, marketable securities or a combination thereof, and the per share fair market value of a Warrant Share is greater than the exercise price, any portion of the Initial OrbiMed Warrant that remains unexercised on such date shall be deemed to have been exercised automatically pursuant to a Cashless Exercise (the “Automatic Cashless Exercise”). Ownership Cap The Holder in any circumstance cannot exercise the Initial OrbiMed Warrant if such exercise would result in the holder and its affiliates to own more than 9.99% of the Company's common stock (the “Ownership Cap”). Adjustments The Exercise Price and the number of Warrant Shares underlying the Initial OrbiMed Warrant are subject to certain anti-dilutive adjustments. These are triggered by events such as stock splits, reclassification of shares, combinations, or substitutions. Additionally, the Exercise Price will be adjusted if shares (which include shares, options, and convertible securities settled in common stock) are issued at a price per share less than the current Exercise Price. These adjustments are collectively referred to as "Warrant Adjustments.” If the Company declares or pays a dividend or distribution on its outstanding common shares payable in cash, capital securities or other property, the Holder shall be entitled to receive, at the time such dividend or distribution is paid, without additional cost to the Holder, the total number and kind of cash, capital securities or other property which the Holder would have received had the Holder owned the Warrant Shares of record as of the date such dividend or distribution was paid (the “Pro-Rata Distribution”). Transfers of Initial OrbiMed Warrant The Initial OrbiMed Warrant may be transferred or assigned in whole or in part, subject to compliance with applicable federal and state securities laws. Allocation of Proceeds and Issuance Costs The agreement explicitly permits the settlement of the Initial OrbiMed Warrant in a cashless manner (i.e. net share settlement) and not indexed to the Company's own stock, therefore, it is considered as a derivative instrument and will be classified as a liability and is subsequently measured at fair value with changes reported to earnings following the proceeds from the issuance of the Initial Term Loan. The fair value of the Initial OrbiMed Warrant at June 30, 2024, and April 30, 2024, $399 and $811, respectively, was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows: June 30, 2024 April 30, 2024 Expected term (years) 5 5 Risk free interest rate 4.3% 4.7% Expected volatility 65.0% 65.0% Dividend yield 0 0 Exercise price $9.56 $9.56 Stock price $5.52 $9.31 The inputs utilized by management to value the warrant liabilities are subjective. The assumptions used in calculating the fair value of the warrant liabilities represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and the Company uses different assumptions, the fair value of the warrant liabilities may be materially different in the future. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes At the end of each interim period, we make our best estimate of the effective tax rate expected to be applicable for the full calendar year and use that rate to provide for income taxes on a current year-to-date basis before discrete items. If a reliable estimate cannot be made, we may make a reasonable estimate of the annual effective tax rate, including use of the actual effective rate for the year-to-date. The impact of the discrete items is recorded in the quarter in which they occur. We utilize the balance sheet method of accounting for income taxes and deferred taxes which are determined based on the differences between the financial statements and tax basis of assets and liabilities given the provisions of the enacted tax laws. In assessing the realizability of the deferred tax assets, we considered whether it is more likely than not that some portion or all of the deferred tax assets will not be realized through the generation of future taxable income. In making this determination, we assessed all of the evidence available at the time including recent earnings, forecasted income projections, and historical financial performance. We have fully reserved deferred tax assets as a result of this assessment. Based on our full valuation allowance against the net deferred tax assets, our effective federal tax rate for the calendar year is zero, and we recorded an immaterial income tax expense in the six months ended June 30, 2024 and 2023. We continue to believe it is more likely than not that some or all of the benefits from its deferred tax assets will not be realized, and accordingly, believe a valuation allowance is still warranted on these assets. Management assesses the available positive and negative evidence, including future reversals of temporary differences, tax-planning strategies and future taxable income, to estimate whether sufficient future taxable income will be generated to permit the use of deferred tax assets. If we conclude it is more likely than not that a portion, or all, of our deferred tax assets will not be realized, the deferred tax asset is reduced by a valuation allowance. A significant piece of objective negative evidence evaluated is the cumulative loss incurred over recent years. Such objective negative evidence limits the ability to consider other subjective positive evidence. The amount of the deferred tax asset considered realizable could be adjusted if estimates of future taxable income change or if objective negative evidence, in the form of cumulative losses, is no longer present and additional weight is given to subjective evidence such as future growth. We evaluate the appropriateness of its valuation allowance on a quarterly basis. |
Dynavax Purchase
Dynavax Purchase | 6 Months Ended |
Jun. 30, 2024 | |
Business Combination and Asset Acquisition [Abstract] | |
Dynavax Purchase | Dynavax Purchase We purchased all of the intellectual property and trial drug substance for nelitolimod from Dynavax Technologies (“Dynavax”) in 2020. This was a purchase of in-process research and development (“IPR&D”). Nelitolimod, an investigational agent in development, is a toll-like receptor 9 (“TLR9”) agonist which is believed to bind to the TLR9 receptors found on suppressive immune cells including myeloid-derived suppressor cells (“MDSCs”) and antigen-presenting immune cells. We believe that nelitolimod, when delivered using our PEDD devices, can improve therapeutic distribution to solid tumors and improve outcomes for liver metastases and pancreatic cancer. Payments under the Dynavax purchase agreement consist of: (a) an upfront payment of $9,000, (b) milestone payments upon the achievement of certain development and commercial milestones, and (c) royalty payments based on aggregate annual net sales after nelitolimod receives Food and Drug Administration ("FDA") approval to be sold. The milestone payments range from $1,000 to $10,000, triggered by development achievements for each of up to four indications. The development milestone payments cannot exceed $170,000. We have made milestone payments of $1,000 in September 2021, after initiating our clinical study of uveal melanoma liver metastases, June 2022, after initiating our clinical study for primary liver tumors, and August 2023, after initiating our clinical study for pancreatic cancer. In aggregate, the commercial milestones shall not exceed $80,000. We will also pay annual royalties at the rate of 10.0% for aggregate annual net sales less than or equal to $1,000,000 and 12.0% for aggregate annual net sales above that amount. We record the milestone payments in R&D expense when they are incurred. We have reflected these milestone payments in the Condensed Consolidated Statements of Cash Flows as investing activities to reflect the contractual investment in the IPR&D. The milestone payments and royalty payments are contingent upon future events and therefore will also be recorded as expense when it is probable that a milestone has been achieved or when royalties are due. |
Standby Equity Purchase Agreeme
Standby Equity Purchase Agreement | 6 Months Ended |
Jun. 30, 2024 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Standby Equity Purchase Agreement | Contingent Earnout Liability In connection with the execution of the Merger Agreement (see Note (3) Business Combination) , MTAC entered into the Sponsor Support Agreement. Pursuant to the Sponsor Support Agreement, the 3,125,000 Sponsor Earnout Shares became unvested and subject to potential forfeiture if certain triggering events are not achieved prior to the 5 th anniversary of the Closing Date. Pursuant to the Sponsor Support Agreement, (i) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $15.00 for any 20 trading days within a period of 30 consecutive trading days, (ii) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $20.00 for any 20 trading days within a period of 30 consecutive trading days, (iii) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $25.00 for any 20 trading days within a period of 30 consecutive trading days; and (iv) 25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during the five year period following the Closing, the volume weighted average price of our Common Stock equals or exceeds $30.00 for any 20 trading days within a period of 30 consecutive trading days. Additionally, the Sponsor Earnout Shares will vest if there is a change in control of our company on or before the 5 th anniversary of the Closing Date that results in the holders of our Common Stock receiving a price per share equal to or in excess of the applicable earnout targets. Any such shares held by the Sponsor Holders that remain unvested after the 5 th anniversary of the Closing will be forfeited. The estimated fair value of the contingent earnout liability at the closing on August 10, 2023, was $28,927 based on a Monte Carlo simulation valuation model. The liability was remeasured to its fair value of $18,632 and $8,931 as of December 31, 2023 and June 30, 2024, respectively. This remeasurement resulted in the recording of a gain of $13,689 and $9,701 for the three and six months ended June 30, 2024, respectively, classified as change in fair value of contingent earnout liability in the Condensed Consolidated Statements of Operations. Assumptions used in the valuation are described below: June 30, December 31, Current stock price $ 5.52 $ 8.45 Expected share price volatility 65.0 % 65.0 % Risk-free interest rate 4.4 % 3.9 % Expected term (years) 4.11 4.60 Estimated dividend yield — % — % The estimated fair value of the liability was determined using a Monte Carlo simulation valuation model using a distribution of potential outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including: (a) expected volatility, which is based on the historical equity volatility of publicly traded peer companies for a term equal to the expected term of the earnout period; (b) expected term, which we based on the earnout period per the agreement; (c) risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the earnout period; and (d) expected dividend yield, which we estimate to be 0% based on the fact that we have never paid or declared dividends. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision. In October 2023, we entered into the SEPA with Yorkville. Yorkville is a fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company shall have the right, but not the obligation, to sell to Yorkville up to $30.0 million of Common Stock, par value $0.0001 per share, at the Company’s request any time during the commitment period commencing on October 2, 2023 (the “Effective Date”), and terminating on the first day of the month following the 24-month anniversary of the Effective Date. Each issuance and sale by the Company to Yorkville under the SEPA (an “Advance”) is subject to a maximum limit equal to the greater of: (i) an amount equal to 100% of the average of the daily volume of the Common Stock on the Nasdaq Stock Market (“Nasdaq”) for the 10 trading days immediately preceding an Advance notice, or (ii) 1,000,000 shares of Common Stock. At the election of the Company, the shares will be issued and sold to Yorkville at a per-share price equal to: (i) 96.0% of the Market Price (as defined below) for any period commencing on the receipt of the Advance notice by Yorkville and ending on 4:00 p.m. New York City time on the applicable Advance notice date (the “Option 1 Pricing Period”), or (ii) 97.0% of the Market Price for any three As described in Note (2) Summary of Significant Accounting Policies , the SEPA is accounted for as a derivative and is recognized as a liability measured at fair value in accordance with ASC 820. The Company intends to utilize the SEPA to access capital to fund its operations. The Company did not issue any Advances during the year ended December 31, 2023. The estimated fair value of the SEPA liability on December 31, 2023, was $185, which was determined using a scenario-based valuation model. The liability was remeasured to its fair value of $394 as of June 30, 2024, and is classified within other long-term liabilities in the Condensed Consolidated Balance Sheets. This remeasurement resulted in the recognition of a loss of $209 for six months ended June 30, 2024, classified as change in fair value of SEPA, tranche and warrant liabilities in the Condensed Consolidated Statement of Operations. Assumptions used in the valuation are described below: Valuation assumptions: June 30, 2024 December 31, 2023 Expected draws $ 13,000 $ 5,000 Expected probability of draws 90% - 100% 90 % Risk-free interest rate 5.5 % 5.4 % The estimated fair value of the liability was determined using a scenario-based valuation model which assigned a probability to a number of different outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including: (a) total expected draws of $13,000 and $5,000, at June 30, 2024, and December 31, 2023, respectively, through the issuance of multiple separate advances under the Option 2 Pricing Period at June 30, 2024, and Option 1 Pricing Period at December 31, 2023; (b) the expected probability of the draws on the SEPA, which we estimate based on our expectation of the draws being completed; and (c) risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the agreement in relation to the date of the expected draw. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Debt | Debt On April 30, 2024 (the "OrbiMed Closing Date"), we entered into the Credit Agreement with OrbiMed, a healthcare investment firm, and certain of its affiliates to support the execution of strategic expansion plans, fuel continued growth, and provide financial flexibility. Pursuant to the to the Agreement, the lender agreed to provide a term loan facility to the borrower, in an aggregate principal amount of $50,000, as follows: a. $25,000 funded on the OrbiMed Closing Date (the “Initial Term Loan”). b. $10,000 term loan available at the election of the borrower, provided that Product Revenue Base (defined below) for the trailing 12-months ending on the last day of the month immediately prior to the funding of such loan was at least $30,000 (the “First Delayed Draw Term Loan Commitment”). The First Delayed Draw Term Loan Commitment expires on June 30, 2025. c. An additional $15,000 term loan available at the election of the borrower, provided that Product Revenue Base (defined below) for the trailing 12-months ending on the last day of the month immediately prior to the funding of such loan was at least $50,000 (the “Second Delayed Draw Term Loan Commitment” and together with the First Delayed Draw Term Loan Commitment the “DDTL Commitments”). The Second Delayed Draw Term Loan Commitment expires on December 31, 2025. The term loan will mature on April 30, 2029. On April 30, 2024, we borrowed the initial commitment amount, resulting in gross proceeds of $25,000. The Credit Agreement includes a subjective acceleration clause whereby an event of default, including a material adverse change in the business, operations, or conditions (financial or otherwise), could result in the acceleration of the obligations under the Credit Agreement. Under certain circumstances, a default interest rate of an additional 4.0% per annum will apply, at the election of OrbiMed, on all outstanding obligations during the occurrence and continuance of an event of default. OrbiMed can also declare all or a portion of the outstanding principal amount of the loan due and payable, and cancel any unmade draws. OrbiMed has not exercised its right under this clause, as there have been no such events. Repayment If the “Product Revenue Base” (i.e., with respect to any period, the net revenues for such period from sales of TriNav) on a trailing 12-month basis does not equal or exceed the specified amount as stipulated in table below, the Borrower will start repaying the outstanding principal amount of the Term Loans. Such repayments will commence in the calendar month immediately following the applicable Test Date (stipulated in the table below) and occur on the last day of each calendar month ("Amortization Payment Date"). The repayments are made in equal monthly installments, calculated from the first Amortization Payment Date through the Maturity Date and the balance principal amount of the Term Loans shall be repaid on the Maturity Date. The repayments include the applicable Repayment Premium and the Exit Fee (each as defined below). The repayment of the Term Loans as aforementioned, is referred to as the “Revenue Base Redemption Feature.” Test Dates (fiscal Quarter Ending) Product Revenue Base for 12 months Period September 30, 2024 $ 22,300 December 31, 2024 26,200 March 31, 2025 29,600 June 30, 2025 33,400 September 30, 2025 37,800 December 31, 2025 42,700 March 31, 2026 46,400 June 30, 2026 and each Fiscal Quarter ending thereafter 50,000 Repayment Premium All repayments and prepayments of the Term Loans (other than on Maturity Date) shall be accompanied by the payment of the premium, which shall be determined based on the timing of the repayment as follows (the “Repayment Premium”): Time of Repayment Premium Rate Within the first 12 months from the funding date of each respective loan. 3.0% plus the Make-Whole Amount (defined below) (1) After the first 12 months but before the 24-month anniversary of the funding date of each respective loan. 3.0% After the 24-month anniversary but before the 36-month anniversary of the funding date of each respective loan. 2.0% After the 36-month anniversary but before the 48-month anniversary of the funding date of each respective loan. 1.0% After the 48-month anniversary of the funding date of each respective loan. 0.0% (1) “Make-Whole Amount” is equal to the sum of the remaining scheduled interest payments through the 12-month anniversary of the closing date of each respective loa n. Interest Rate and Payment The interest rate is calculated as SOFR Rate for the interest period (which shall not be less than 4.0% (the “Floor”)) plus the 8.5% (the “Interest Rate”). Until the first full interest period after the 15 months anniversary of the OrbiMed Closing Date, 3.5% of the Interest Rate shall be designated as paid-in-kind interest, which is added to the outstanding principal amount of the Loans (the “PIK Interest”). However, the Borrower upon written notice can elect to pay all interest in cash, or to pay a percentage less than 3.5% as PIK Interest. On and after occurrence of any Event of Default, until such Event of Default is cured, the Borrower is obligated to pay 4.0% in addition to the otherwise applicable Interest Rate (the “Default Rate”). Interest payments (except PIK Interest) are due on the last day of the month. Whenever a prepayment is made on the principal of the Term Loans, the accrued interest on the amount prepaid is also due on such date. Debt Related Fees (1) Exit Fee The Borrower on the repayment of the Term Loans is obligated to pay an additional fee equal to 4.0% of the of the principal amount being repaid. This applies whether the repayment is made on the Maturity Date, or under any other conditions specified in the Agreement (the “Exit Fee”). (2) Commitment Fee The Borrower on the funding date of the Term Loans, shall pay a commitment fee to the Lender, equal to 2.0% of the principal amount drawn (the “Commitment Fee”). (3) Undrawn Fee Every month, the Borrower is obligated to remit a fee to the Lender, calculated as 0.25% per annum of the total undrawn amount under the DDTL Commitments. (4) Administrative Fee The Borrower will pay to the Agent for its own account a quarterly loan administration fee of $10,000, payable in advance, with the first payment due and payable upon the OrbiMed Closing Date. Increased Costs If, at any time, any Lender incurs additional cost, reductions in any sum receivable by the Lender under the Agreement or reduction in the rate of return with respect to the Term Loans because of any change in applicable law or government rule including laws regarding capital adequacy, reserve requirements, taxes, or similar requirements, etc., (collectively, “Yield Adjustment Events”), the Borrower will pay the Lenders an additional amount to compensate the Lender for such increased costs or reduction in rate of return (the “Yield Protection Adjustment Feature”). Taxes Unless otherwise required by applicable law, any and all payments shall be made free and clear of and without deduction for any taxes; provided, that if any taxes shall be deducted (as required by law or otherwise) from such payments, then the Borrower or the withholding agent shall be entitled to make such deductions and shall timely pay the full amount deducted to the relevant government authority in accordance with applicable law. If such taxes are Non-Excluded Taxes (as defined in the Agreement), then the sum payable by the Borrower shall be increased as necessary so that after all required deductions have been made, the Lenders receive an amount equal to the sum it would have received had no such deduction been made (the "Tax Gross-Up Feature”). Warrant In addition to issuing the Initial OrbiMed Warrant (see Note (10) Warrants for further discussion), on each of the closings of the Delayed Draw Commitment Amounts, if any, we agreed to issue additional warrants to purchase a number of shares of our common stock determined by dividing 5.0% of the applicable Delayed Draw Commitment Amount by the 10-day volume weighted average sale price of our common stock as of the issue date (the “Subsequent OrbiMed Warrants” and collectively, with the Initial OrbiMed Warrant, the “OrbiMed Warrants” and together with the SPAC Warrants, the “Warrants”). The Subsequent Warrants will expire seven years from each applicable issuance date, if any. In connection with the OrbiMed Warrants, we entered into a Registration Rights Agreement with OrbiMed (the “OrbiMed Registration Rights Agreement”), whereby OrbiMed will have certain customary registration rights with respect to the shares of common stock underlying the OrbiMed Warrants. If we fail to comply with certain of our obligations under the OrbiMed Registration Rights Agreement with respect to maintaining an effective registration statement covering shares of Common Stock underlying the OrbiMed Warrants, then the expiration date of an OrbiMed Warrant may be extended. Additionally, the Initial OrbiMed Warrant is subject to customary price-based anti-dilution protections, such that, in certain circumstances, if we issue shares of our common stock below the current exercise price of the Initial OrbiMed Warrant, the exercise price of the Initial OrbiMed Warrant will be adjusted downward based on such issuance. Accounting Treatment In accordance with ASC 470, Debt , we recorded the Initial Term Loan as long term debt, and recorded the costs incurred to obtain the loan as contra-debt. We incurred $2,593 in legal, origination and other fees to acquire the Credit Agreement. In addition, we determined that the Initial OrbiMed Warrant met the definition of a derivative under ASC 815, Derivatives and Hedging , and should be recorded as a liability, and that we should bifurcate and separately recognize the Revenue Base Redemption Feature. At April 30, 2024, we determined the initial value of the Initial OrbiMed Warrant was $811 using the Black-Scholes pricing model (see Note (10) Warrants for further discussion.). We determined the initial value of the Revenue Base Redemption Feature to be $729 using a Monte Carlo simulation of future revenue and valuing the Initial Term Loan using the with and without method. The proceeds related to the Credit Agreement with OrbiMed of $25,000 will be allocated first to the OrbiMed Warrants and to the Revenue Base Redemption Feature, in an amount equal to their respective fair value at the OrbiMed Closing Date. The OrbiMed Warrants and the Revenue Base Redemption will be remeasured subsequently, with changes recorded to expense at each remeasurement date. Any residual proceeds should be allocated to the Initial Term Loan, whereas the issuances should be allocated in proportion to the proceeds between the Initial Term Loan and the Initial Warrant. During the three months ended June 30, 2024, we recognized interest of $596 related to the Initial Term Loan, of which $151 was recorded as PIK interest. The remaining $445 was paid in cash to OrbiMed. We also expensed $237 of the capitalized debt issuance costs, which was charged to non-cash interest, and we accreted $31 of the exit fee which will be due at the termination of the Initial Term Loan. The following table summarizes activity within the Initial Term Loan for the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Initial draw $ 25,000 Debt issuance costs Cash issuance costs (2,593) Noncash issuance costs: Revenue base redemption liability (729) Warrant liability (811) Balance at April 30, 2024 $ 20,867 Amortization of debt issuance costs 237 PIK interest 151 Accretion of exit fee liability 31 Balance at June 30, 2024 $ 21,286 |
Convertible Preferred Stock
Convertible Preferred Stock | 6 Months Ended |
Jun. 30, 2024 | |
Temporary Equity Disclosure [Abstract] | |
Convertible Preferred Stock | Convertible Preferred Stock Series A Convertible Preferred Stock At the Closing Date on August 10, 2023, we issued 4,015,002 shares of Series A Convertible Preferred Stock at a purchase price of $10.00 per share for an aggregate purchase price of $40,150, pursuant to separate subscription agreements dated June 7, 2023, and July 4, 2023 (collectively, the “Subscription Agreements”). As of June 30, 2024, the Company is authorized to issue up to 10,000,000 shares of preferred stock with 5,984,998 shares available for issuance. The original issue price of the Series A Convertible Preferred Stock was $10.00. The Series A Convertible Preferred Stock accrues cumulative dividends at the rate of 8.00% per annum on the original issue price. As of June 30, 2024, total undeclared cumulative dividends were $2,860. We have not recorded the undeclared dividends in our condensed consolidated financial statements, except the statement of operations. All shares of Series A Convertible Preferred Stock had the following rights: (i) Conversion (a) Optional Conversion The Series A Convertible Preferred Stock are convertible at any time at the option of the holder thereof into the number of shares of our Common Stock determined by the quotient of (i) the sum of $10.00 (as adjusted for any stock dividend, stock split, reverse stock split, combination or similar event affecting the Series A Convertible Preferred Stock) (the “Liquidation Preference”) and, if we have not elected to otherwise pay the accrued Annual Dividends (as defined below) in cash to the holder, the accrued Annual Dividends on such shares as of the date of conversion, divided by (ii) the Conversion Price (as defined in our Certificate of Designations, Preferences, and Rights of Series A Convertible Preferred Stock (the "Certificate of Designations")) of such shares in effect at the time of conversion. (b) Automatic Conversion On the four-year anniversary of the Closing, all then outstanding shares of Series A Convertible Preferred Stock shall automatically convert into the number of shares of our Common Stock equal to the quotient of (i) the sum of the Liquidation Preference and if we had not elected to otherwise pay the accrued Annual Dividends in cash to the holder, the accrued Annual Dividends on such shares as of the date of conversion, divided by (ii) the Conversion Price of such shares in effect at the time of conversion. (ii) Voting Rights Holders of the Series A Convertible Preferred Stock are entitled to vote with the holders of our Common Stock on all matters submitted to a vote of our stockholders, except as otherwise provided in the Certificate of Designations or as required by applicable law, voting together with the holders of our Common Stock as a single class. Each holder is entitled to a number of votes in respect of the shares of Series A Convertible Preferred Stock owned as of the record date by it, or if no such record date is established, as of the date such vote is taken or any written consent of stockholders is solicited, equal to the quotient of (i) $10.00 divided by (ii) the Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) of our Common Stock as determined at Closing. As long as any shares of Series A Convertible Preferred Stock are outstanding, we shall not, without the affirmative vote of the Holders of a majority of the then-outstanding shares of the Series A Convertible Preferred Stock, (i) amend, alter, repeal or otherwise modify any provision of our certificate of incorporation or the Certificate of Designations in a manner that would alter or change the terms or the powers, preferences, rights or privileges of the Series A Convertible Preferred Stock as to affect them adversely; (ii) authorize, create, increase the authorized amount of, or issue any class or series of capital stock senior to the Series A Convertible Preferred Stock; (iii) increase the authorized number of shares of Series A Convertible Preferred Stock or enter into any agreement with respect to the foregoing. (iii) Dividends Holders of the Series A Convertible Preferred Stock are entitled to participate equally in any dividends declared to holders of Common Stock. In addition, each holder of the Series A Convertible Preferred Stock is entitled to receive cumulative annual dividends that accrue and accumulate daily at a rate per annum (calculated on the basis of an actual 365- or 366-day year, as applicable) equal to 8.00% of the original issue price of $10.00 per share (the "Annual Dividends”). The Annual Dividends will be either paid in cash, paid by issuing fully paid and nonassessable shares of Common Stock, or a combination thereof when, as and if authorized and declared by our Board. Upon conversion or a change of control, any unpaid Annual Dividends will be paid to the holders, either in the form of common stock upon a conversion, or in cash upon a change of control. So long as any shares of Series A Convertible Preferred Stock remain outstanding, unless all Annual Dividends on all outstanding shares of Series A Convertible Preferred Stock have been declared and paid in cash, we will be prohibited from declaring any dividends on, or making any distributions relating to, other classes of our capital stock ranking junior to the Series A Convertible Preferred Stock, subject to certain exceptions. (iv) Anti-dilution Provisions The initial Conversion Price of $10.00 is subject to customary adjustments in the case of certain distributions to holders of our Common Stock payable in shares of our Common Stock, subdivisions, splits or combinations of the shares of our Common Stock and distributions to all holders of shares of our Common Stock of any convertible securities or options or any other assets for which there is no corresponding distribution in respect of the Series A Convertible Preferred Stock. The Conversion Price will automatically reset upon each of February 10, 2025, and July 10, 2027, the eighteen-month and forty-seven-month anniversaries of the Closing Date, to be equal to the lowest of: (i) Initial Conversion Price, subject to adjustments for stock dividends and distributions or other distributions made to common stockholders for which there is no corresponding distribution for Preferred Stock, (ii) the then-current Conversion Price, and (iii) the higher of 1) the Floor Price ($2.10 per share) or 2) the trailing ten (iv) Liquidation Preferences The terms of the Series A Convertible Preferred Stock provide for liquidation preferences in the event of a change in control, liquidation, dissolution, or certain other fundamental transactions of the Company (a “Liquidation Event”), none of which were deemed probable as of June 30, 2024. The Liquidation Preferences of $10.00 per share, plus all unpaid dividends, are payable prior to payment to any class of capital stock that is junior to the Series A Convertible Preferred Stock. If the assets of the Company or the consideration received in such Liquidation Event are insufficient to make payment of the full Liquidation Preferences to all holders of Series A Convertible Preferred Stock, then such assets will be distributed ratably to the holders of Series A Convertible Preferred Stock in proportion to the full amounts to which they would otherwise have been entitled. After payment of the aforementioned Liquidation Preferences, any remaining proceeds from a Liquidation Event will be distributed to all classes of capital stock that are junior to the Series A Convertible Preferred Stock pro rata on an as-if converted basis. The following table summarizes activity in Series A convertible preferred stock in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Issuances Balance at Series A convertible preferred stock (assuming maximum conversion) 25,237,155 — 25,237,155 Total convertible preferred stock 25,237,155 — 25,237,155 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. During periods where we might earn net income, we would allocate to participating securities a proportional share of net income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Our preferred stock, if any, participates in any dividends declared by us and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods where we incurred net losses, we allocate no loss to participating securities because they have no contractual obligation to share in our losses. We computed diluted loss per common share after giving consideration to the dilutive effect of stock options and warrants that are outstanding during the period, except where such nonparticipating securities would be antidilutive. Because we have reported net losses for the six months ended June 30, 2024 and 2023, diluted net loss per common share is the same as basic net loss per common share for those periods. The following potentially dilutive securities (in common stock equivalent shares) have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported: June 30, 2024 2023 Preferred stock 25,237,155 15,522,792 Preferred stock warrants — 2,923,415 Common stock warrants 14,345,917 — Restricted stock units 544,988 — Options to purchase common stock 4,866,070 1,715,211 Shares issuable under the SEPA 4,510,704 — Total 49,504,834 20,161,418 |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation We currently maintain the 2023 Equity Incentive Plan (the “2023 Plan”), which our Board of Directors and stockholders approved in connection with the Business Combination, for purposes of granting equity-based incentive awards to our employees and consultants, including our executive officers and directors. Prior to the Business Combination, TriSalus granted equity incentive awards under the 2009 Amended and Restated Equity Incentive Plan (the “2009 Plan”). The 2009 Plan will not be used following the Business Combination. However, any awards granted under the 2009 Plan remain subject to the terms of the 2009 Plan and the applicable award agreement. Historically, we have used options as an incentive for long-term compensation to our executive officers because options allow our executive officers to realize value from this form of equity compensation only if the value of the underlying equity securities increase relative to the option’s exercise price, which exercise price is set at the fair market value of the underlying equity securities on the grant date. The 2009 Plan and the 2023 Plan are administered by our chief executive officer and chief financial officer, who act on the recommendation of managers of the Company to select the individuals to whom the awards will be granted and to determine the amount and vesting period for the grants. All grants are subject to approval by the board of directors. As of June 30, 2024, the balances under the two plans are below. June 30, 2024 Authorized Outstanding Available for Issue 2009 Plan 1,553,852 1,553,852 — 2023 Plan 7,969,775 3,857,206 4,112,569 Total 9,523,627 5,411,058 4,112,569 2009 Equity Incentive Plan As of June 30, 2024, there were in total 1,489,679 stock options and 64,173 RSUs issued and outstanding under the 2009 Plan. Stock options were granted with an exercise price equal to the estimated fair value of the stock at the date of grant. Prior to the Business Combination, the fair value was determined by a third-party valuation performed in accordance with IRS Section 409A. No awards have been granted subsequent to the Business Combination, as the 2009 Plan was frozen and replaced by the 2023 Plan (see below). Options generally have a ten-year contractual term and typically have graded vesting over one As of June 30, 2024, we had unrecognized compensation expense of $758 and $499, respectively, for options and RSUs granted under the 2009 Plan. The June 30, 2024, balance will be recognized over a weighted average period of 1.4 years. 2023 Equity Incentive Plan As of June 30, 2024, there were in total 3,376,391 stock options and 480,815 RSUs issued and outstanding under the 2023 Plan. Under the 2023 Plan, the Company’s Board may grant equity-based incentive awards to employees, consultants and other service providers of the Company and its affiliates within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended. Initially, 5,585,008 shares were authorized under the 2023 Plan. In addition, the share reserve will automatically increase on January 1 of each year for a period of 10 years, commencing on January 1, 2024, and ending on January 1, 2033, in an amount equal to (1) five percent of the total number of shares of the fully diluted Common Stock determined on December 31 of the preceding year, or (2) a lesser number of shares of Common Stock determined by our Board prior to January 1 of a given year. On January 1, 2024, the authorized shares under the 2023 Plan increased by 2,385,694 shares to 7,970,702. Options for 927 shares of Common Stock were exercised during the six months ended June 30, 2024, reducing the authorized share total to 7,969,775. During the six months ended June 30, 2024, we granted 1,307,613 options, net of forfeitures, with a weighted average fair value of $9.11, and 480,815 restricted stock units, net of forfeitures, with a weighted average fair value of $9.48. As of June 30, 2024, we had unrecognized compensation expense of $13,175 and $3,052, respectively, for options and RSUs granted under the 2023 Plan. The balance at June 30, 2024, will be recognized over a weighted average period of 3.3 years. Our Board, or a duly authorized committee thereof, administers the 2023 Plan. Our Board may also delegate to one or more of our officers the authority to, among other things, (1) designate employees (other than officers) to receive specified stock awards and (2) determine the number of shares subject to such stock awards. Under the 2023 Plan, the Board has the authority to determine award recipients, grant dates, the numbers and types of stock awards to be granted, the applicable fair market value and exercise price, and the provisions of each stock award, including the exercise period and the vesting schedule applicable to a stock award, subject to the limitations of the 2023 Plan. Stock options are granted with an exercise price no less than 100% of the estimated fair value of a share of Common Stock at the date of grant. Employee Stock Purchase Plan We maintain an Employee Stock Purchase Plan ("ESPP"), which provides our eligible employees with an opportunity to purchase shares of Common Stock, to assist us in retaining the services of eligible employees, to secure and retain the services of new employees and to provide incentives for such persons to exert maximum efforts for our success. The ESPP became active in 2024. Initially, 1,396,252 shares of Common Stock were reserved for issuance under the ESPP. The number of shares of Common Stock reserved for issuance under the ESPP will automatically increase on January 1 of each year for a period of up to ten years, beginning on January 1, 2024, and continuing through and including January 1, 2033, by an amount equal to the lesser of (a) two percent (2%) of the total number of shares of the Fully Diluted Common Stock determined on December 31 of the preceding year, and (b) 200% of the Initial Share Reserve. On January 1, 2024, the authorized shares under ESPP increased by 954,278 shares to 2,350,530. During the six months ended June 30, 2024, 41,663 shares were purchased in an offering under the ESPP which closed on June 30, 2024, raising $195. These shares were issued on July 2, 2024. A new offering began on July 1, 2024, and will close on December 31, 2024. |
Commitments And Contingencies
Commitments And Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments And Contingencies | Commitments And Contingencies From time to time, we may have certain contingent liabilities, including litigation, which arise in the ordinary course of its business activities. We accrue contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. In the opinion of management, there are no pending claims for which the outcome is expected to result in a material adverse effect on our condensed consolidated financial position, results of operations, or cash flows. As part of the Business Combination, we entered into the Amended and Restated Registration Rights Agreement with certain investors in MedTech and Legacy TriSalus. Subject to certain requirements and customary conditions, we granted piggyback registration rights and demand registration rights to the parties thereto, agreed to pay certain expenses related to such registrations and agreed to indemnify the parties thereto against certain liabilities related to such registrations. Our registration obligations under the Amended and Restated Registration Rights Agreement will terminate with respect to any party thereto on the date that such party no longer holds any Registrable Securities (as defined in the Amended and Restated Registration Rights Agreement). The Amended and Restated Registration Rights Agreement does not contain liquidated damages or other cash settlement provisions resulting from delays in registering the Company’s securities. We are not a party to any legal proceedings, and we are not aware of any claims or actions pending or threatened against us. In the future, we might from time to time become involved in litigation relating to claims arising from our ordinary course of business. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | Leases We have four property leases in effect as of June 30, 2024, which we account for as operating leases: • A lease for our principal administrative and production facility at 6272 West 91st Avenue, Westminster, Colorado, which expires on December 31, 2026. This lease includes two options to extend the lease by five years each from the end of the then current term. • A lease for office space at 2275 Half Day Road, Bannockburn, Illinois, which expires in November 2024. This lease includes an option to extend the lease by three years at the end of the current term. • A lease for office space at 1000 Chapel View Blvd, Cranston, Rhode Island, which expires in October 2024. This lease includes an option to extend the lease by two years at the end of the current term. • A lease for laboratory and research space at 1 Hoppin Street, Providence, Rhode Island, which expires on February 1, 2024. |
Leases | Leases We have four property leases in effect as of June 30, 2024, which we account for as operating leases: • A lease for our principal administrative and production facility at 6272 West 91st Avenue, Westminster, Colorado, which expires on December 31, 2026. This lease includes two options to extend the lease by five years each from the end of the then current term. • A lease for office space at 2275 Half Day Road, Bannockburn, Illinois, which expires in November 2024. This lease includes an option to extend the lease by three years at the end of the current term. • A lease for office space at 1000 Chapel View Blvd, Cranston, Rhode Island, which expires in October 2024. This lease includes an option to extend the lease by two years at the end of the current term. • A lease for laboratory and research space at 1 Hoppin Street, Providence, Rhode Island, which expires on February 1, 2024. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The interim unaudited condensed consolidated financial statements are comprised of the financial statements of the Company. In management’s opinion, the interim financial data presented includes all adjustments necessary for a fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2024. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2023. The December 31, 2023, condensed consolidated balance sheet is derived from the audited balance sheet included in the Annual Report on Form 10-K for the year ended December 31, 2023. A summary of our significant accounting policies is included in Note 2 to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023. Certain of our accounting policies are considered critical, as these policies are the most important to the depiction of our financial statements and require significant, difficult or complex judgments by us, often employing the use of estimates about the effects of matters that are inherently uncertain. Such policies are summarized below. |
Warrants Liabilities | Warrants Liabilities Freestanding financial instruments that permit the holder to acquire shares that are either puttable by the holder, redeemable or contingently redeemable are required to be reported as liabilities in the financial statements. We present such liabilities on the balance sheets at their estimated fair values. Changes in fair value of the liability are calculated each reporting period, and any change in value are recognized in the condensed consolidated statements of operations. In connection with the Business Combination, we assumed warrants to purchase common stock. The warrants include the Public Warrants, Private Placement Warrants and Working Capital Warrants. We value the liability for both sets of warrants based on the trading price of the publicly held warrants. See Note (10) Warrants and (4) Financial Instruments for further discussion. In connection with the $25,000 funded amount on the OrbiMed Closing Date (the "Initial OrbiMed Loan"), we issued the Initial OrbiMed Warrant, which we classified as a derivative liability due to failure to meet the equity classification criteria under ASC 815-40. We calculated the fair value of the Initial OrbiMed Warrant based on the Black-Scholes-Merton option pricing model. This model considers several variables and assumptions in estimating the fair value of financial instruments, including the per-share fair value of the underlying common stock, exercise price, expected term, risk-free interest rate, expected stock price volatility over the expected term, and expected annual dividend yield. We calculated the expected terms as the contractual expiration period. The risk-free interest rate is estimated using the rate of return on U.S. treasury notes with a life that approximates the expected term. Our common stock does not have sufficient trading history and, therefore, we used the historical volatility of the stock prices of similar publicly traded peer companies. We utilized a dividend yield of zero, as we have no history or plan of declaring dividends on the Company's common stock. |
Revenue Base Redemption Liability | Revenue Base Redemption Liability We determined that we should bifurcate and separately recognize the Revenue Base Redemption Feature (see Note (14) Debt for further detail). We determined the value of the Revenue Base Redemption Feature using a Monte Carlo simulation of future revenue and valuing the Initial Term Loan using the with and without method. |
Contingent Earnout Liability | Contingent Earnout Liability In connection with the execution of the Merger Agreement, MTAC entered into a sponsor support agreement (the “Sponsor Support Agreement”) with MedTech Acquisition Sponsor LLC (the "Sponsor”), Legacy TriSalus and MTAC’s directors and officers (the Sponsor and MTAC’s directors and officers, collectively, the “Sponsor Holders”). Pursuant to the Sponsor Support Agreement, 3,125,000 shares of common stock in the Company ("Common Stock") held by the Sponsor Holders immediately after the Closing Date (such shares, the “Sponsor Earnout Shares”) became unvested and subject to potential forfeiture if certain triggering events are not achieved prior to the 5th anniversary of the Closing Date (the “Earnout Period”). The Sponsor Earnout Shares are classified as a liability in the Company’s condensed consolidated balance sheets because they do not qualify as being indexed to the Company’s own stock. The earnout liability was initially measured at fair value at the Closing Date and is subsequently remeasured at the end of each reporting period. The change in fair value of the earnout liability is recorded in the condensed consolidated statements of operations. See Notes (9) Contingent Earnout Liability and (4) Financial Instruments and for further detail. |
Standby Equity Purchase Agreement | Standby Equity Purchase Agreement In October 2023, we entered into the SEPA with Yorkville. Pursuant to the SEPA, we have the right, but not the obligation, to sell to Yorkville up to $30 million of shares of Common Stock at our request at any time during the 24 months following the execution of the SEPA, subject to certain conditions. We evaluated the contract that includes the right to require Yorkville to purchase shares of common stock in the future (“put right”) considering the guidance in ASC 815-40, Derivatives and Hedging — Contracts on an Entity’s Own Equity and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting. Each period, we analyze the terms of the freestanding put right and record the balance as a liability. Changes in the fair value are recognized in earnings. |
Use of Estimates | Use of Estimates |
Research and Development | Research and Development Research and development (“R&D”) costs include our engineering, regulatory, pre-clinical and clinical activities. R&D costs are expensed as incurred. We are required to estimate our expenses resulting from our obligations under agreements with vendors, consultants, and contract research organizations, in connection with conducting R&D activities. The financial terms of these contracts are subject to negotiations, which vary from agreement to agreement and may result in payment flows that do not match the periods over which goods or services are provided. We reflect R&D expenses in our condensed consolidated financial statements by matching those expenses with the period in which services and efforts are expended. We account for these expenses according to the progress of the agreements, along with the preparation of financial models, taking into account discussions with research and other key personnel as to the progress of studies or other services being performed. To date, we have had no material differences between our estimates of such expenses and the amounts actually incurred. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods are consumed or services are performed |
Recently Adopted Accounting Pronouncements and Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions , which clarifies the guidance on ASC Topic 820 on the fair value measurement of equity security that is subject to a contractual sale restriction and requires specific disclosures related to such an equity security. Specifically, the ASU clarifies that a "contractual sale restriction prohibiting the sale of an equity security is a characteristic of the reporting entity holding the equity security and is not included in the equity security's unit of account." As such, the entity should not apply a discount related to the contractual sale restriction when measuring the equity security's fair value. In addition, the ASU prohibits an entity from recognizing a contractual sale restriction as a separate unit of account. For public companies, the amendments for this update are effective for fiscal years beginning after December 15, 2023. For all other entities, the amendments are effective for fiscal year beginning after December 15, 2024, and interim periods within those fiscal years. We adopted ASU 2022-03 on January 1, 2024. The effect of the adoption had an immaterial impact on our condensed consolidated financial statements. In November 2023, the FASB issued ASU 2023-07, Improvements to Disclosures About Reportable Segments . The ASU improves reportable segment disclosure requirements through enhanced disclosures about significant segment expenses in annual and interim reports, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, add disclosure requirements for entities with a single reportable segment, and other enhancements. The ASU is effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We adopted ASU 2023-07 on January 1, 2024. The effect of the adoption had no impact on our condensed consolidated financial statements. Accounting Pronouncements Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures . Under the ASU, Public Business Entity ("PBE") must annually "(1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate)." This guidance is effective for public companies for annual periods beginning after December 15, 2024. For other companies, the amendments are effective for annual periods beginning after December 15, 2025. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements. In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, which clarifies the guidance on ASC Topic 718 by illustrating how to apply the scope guidance to determine whether a profit interest award should be accounted for as a shared-based payment arrangement under ASC 718 or another accounting standard (e.g., employee profit-sharing arrangement under ASC 710). The ASU aims to reduce the complexity diversity in practice by adding an example to ASC 718 that describes four fact patterns and illustrates how an entity evaluates common terms and characteristics of profit interests and similar awards to reach a conclusion about whether an award meets the scope conditions in ASC 718-10-15-3. The ASU is effective for all public entities for fiscal years beginning after December 15, 2024 and interim periods within those fiscal years. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements. In March 2024, the FASB issued ASU 2024-02, Codification Improvements — Amendments to Remove References to the Concept Statements, |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Changes in Fair Value of Outstanding Warrant and Tranche Liabilities | The following tables summarize the changes in fair value of our outstanding warrant liabilities, Exchange Warrants, contingent earnout liability, SEPA derivative liability, and revenue base redemption liability for the six months ended June 30, 2024 and 2023. Warrant Liabilities Fair Value at Change in Issuances Fair Value at Public Warrants - Level 1 $ 9,855 $ 4,068 $ (11,068) $ 2,855 Private Placement Warrants - Level 2 5,871 2,204 (855) 7,220 Working Capital Warrants - Level 2 1,190 440 — 1,630 Total $ 16,916 $ 6,712 $ (11,923) $ 11,705 Exchange Warrants Fair Value at Change in Issuances Fair Value at Exchange Warrants (Equity-Classified) - Level 2 $ — $ — $ 11,923 $ 11,923 Level 3 Fair Value at Change in Issuances Fair Value at Contingent earnout liability $ 18,632 $ (9,701) $ — $ 8,931 SEPA derivative liability $ 185 $ 209 $ — $ 394 Initial OrbiMed Warrant liability $ — $ (413) $ 811 $ 399 Revenue base redemption liability $ — $ (13) $ 729 $ 715 Level 3 Fair Value at Change in Issuances Net Transfer Fair Value at Warrant liabilities $ 369 $ (1) $ (106) $ — $ 262 Series B-2 tranche liabilities $ 4,702 $ (2,241) $ (1,502) $ — $ 959 Series B-3 warrant liabilities $ 15,819 $ (1,248) $ 2,619 $ — $ 17,190 |
Cash, Cash Equivalents and Re_2
Cash, Cash Equivalents and Restricted Cash (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash, cash equivalents and restricted cash, as presented in the Condensed Consolidated Statements of Cash Flows, consisted of the following: June 30, December 31, Cash and cash equivalents $ 16,481 $ 11,777 Restricted cash (included in Other assets) 350 350 Total cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 16,831 $ 12,127 |
Schedule of Restricted Cash | Cash, cash equivalents and restricted cash, as presented in the Condensed Consolidated Statements of Cash Flows, consisted of the following: June 30, December 31, Cash and cash equivalents $ 16,481 $ 11,777 Restricted cash (included in Other assets) 350 350 Total cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 16,831 $ 12,127 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Summary of Components of Inventory | The components of inventory are summarized as follows: June 30, December 31, Raw materials $ 901 $ 607 Finished goods 2,542 2,055 Reserve for obsolete inventory — (117) Inventory $ 3,443 $ 2,545 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The estimated aggregate amortization expense for intangible assets subject to amortization for each of the five succeeding fiscal years is as follows: 2024 $ 25 2025 51 2026 51 2027 51 2028 51 Thereafter 884 $ 1,113 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued Liabilities consists of the following: June 30, December 31, Accrued liabilities - clinical trials $ 3,706 $ 3,115 Accrued liabilities 2,763 2,790 Accrued bonus 1,664 3,736 Accrued vacation 351 327 Accrued payroll 386 557 Accrued employee benefits 500 — Accrued taxes 37 31 Total accrued liabilities $ 9,407 $ 10,556 |
Contingent Earnout Liability (T
Contingent Earnout Liability (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Fair Value Measurement Inputs and Valuation Techniques | Assumptions used in the valuation are described below: June 30, December 31, Current stock price $ 5.52 $ 8.45 Expected share price volatility 65.0 % 65.0 % Risk-free interest rate 4.4 % 3.9 % Expected term (years) 4.11 4.60 Estimated dividend yield — % — % The following table summarizes activity in the Public Warrants, Private Placement Warrants, Working Capital Warrants and Exchange Warrants in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Exercises Issuances Retirements / Conversions Balance at Public Warrants 8,281,779 — — (6,529,954) 1,751,825 Private Placement Warrants 4,933,333 — — (504,685) 4,428,648 Working Capital Warrants 1,000,000 — — — 1,000,000 Exchange Warrants (Equity-Classified) — — — 7,034,639 7,034,639 The fair value of the Initial OrbiMed Warrant at June 30, 2024, and April 30, 2024, $399 and $811, respectively, was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows: June 30, 2024 April 30, 2024 Expected term (years) 5 5 Risk free interest rate 4.3% 4.7% Expected volatility 65.0% 65.0% Dividend yield 0 0 Exercise price $9.56 $9.56 Stock price $5.52 $9.31 Valuation assumptions: June 30, 2024 December 31, 2023 Expected draws $ 13,000 $ 5,000 Expected probability of draws 90% - 100% 90 % Risk-free interest rate 5.5 % 5.4 % |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Warrants and Rights Note Disclosure [Abstract] | |
Schedule of Warrants Outstanding | Warrants that have not been tendered for exchange and outstanding at June 30, 2024, and December 31, 2023, are as follows: June 30, December 31, Public Warrants 1,751,825 8,281,779 Private Placement Warrants 4,428,648 4,933,333 Working Capital Warrants 1,000,000 1,000,000 Initial OrbiMed Warrant 130,805 — Exchange Warrants (Equity-Classified) 7,034,639 — Total warrants 14,345,917 14,215,112 |
Fair Value Measurement Inputs and Valuation Techniques | Assumptions used in the valuation are described below: June 30, December 31, Current stock price $ 5.52 $ 8.45 Expected share price volatility 65.0 % 65.0 % Risk-free interest rate 4.4 % 3.9 % Expected term (years) 4.11 4.60 Estimated dividend yield — % — % The following table summarizes activity in the Public Warrants, Private Placement Warrants, Working Capital Warrants and Exchange Warrants in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Exercises Issuances Retirements / Conversions Balance at Public Warrants 8,281,779 — — (6,529,954) 1,751,825 Private Placement Warrants 4,933,333 — — (504,685) 4,428,648 Working Capital Warrants 1,000,000 — — — 1,000,000 Exchange Warrants (Equity-Classified) — — — 7,034,639 7,034,639 The fair value of the Initial OrbiMed Warrant at June 30, 2024, and April 30, 2024, $399 and $811, respectively, was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows: June 30, 2024 April 30, 2024 Expected term (years) 5 5 Risk free interest rate 4.3% 4.7% Expected volatility 65.0% 65.0% Dividend yield 0 0 Exercise price $9.56 $9.56 Stock price $5.52 $9.31 Valuation assumptions: June 30, 2024 December 31, 2023 Expected draws $ 13,000 $ 5,000 Expected probability of draws 90% - 100% 90 % Risk-free interest rate 5.5 % 5.4 % |
Standby Equity Purchase Agree_2
Standby Equity Purchase Agreement (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Fair Value Measurement Inputs and Valuation Techniques | Assumptions used in the valuation are described below: June 30, December 31, Current stock price $ 5.52 $ 8.45 Expected share price volatility 65.0 % 65.0 % Risk-free interest rate 4.4 % 3.9 % Expected term (years) 4.11 4.60 Estimated dividend yield — % — % The following table summarizes activity in the Public Warrants, Private Placement Warrants, Working Capital Warrants and Exchange Warrants in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Exercises Issuances Retirements / Conversions Balance at Public Warrants 8,281,779 — — (6,529,954) 1,751,825 Private Placement Warrants 4,933,333 — — (504,685) 4,428,648 Working Capital Warrants 1,000,000 — — — 1,000,000 Exchange Warrants (Equity-Classified) — — — 7,034,639 7,034,639 The fair value of the Initial OrbiMed Warrant at June 30, 2024, and April 30, 2024, $399 and $811, respectively, was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows: June 30, 2024 April 30, 2024 Expected term (years) 5 5 Risk free interest rate 4.3% 4.7% Expected volatility 65.0% 65.0% Dividend yield 0 0 Exercise price $9.56 $9.56 Stock price $5.52 $9.31 Valuation assumptions: June 30, 2024 December 31, 2023 Expected draws $ 13,000 $ 5,000 Expected probability of draws 90% - 100% 90 % Risk-free interest rate 5.5 % 5.4 % |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt Instruments | The repayment of the Term Loans as aforementioned, is referred to as the “Revenue Base Redemption Feature.” Test Dates (fiscal Quarter Ending) Product Revenue Base for 12 months Period September 30, 2024 $ 22,300 December 31, 2024 26,200 March 31, 2025 29,600 June 30, 2025 33,400 September 30, 2025 37,800 December 31, 2025 42,700 March 31, 2026 46,400 June 30, 2026 and each Fiscal Quarter ending thereafter 50,000 Repayment Premium All repayments and prepayments of the Term Loans (other than on Maturity Date) shall be accompanied by the payment of the premium, which shall be determined based on the timing of the repayment as follows (the “Repayment Premium”): Time of Repayment Premium Rate Within the first 12 months from the funding date of each respective loan. 3.0% plus the Make-Whole Amount (defined below) (1) After the first 12 months but before the 24-month anniversary of the funding date of each respective loan. 3.0% After the 24-month anniversary but before the 36-month anniversary of the funding date of each respective loan. 2.0% After the 36-month anniversary but before the 48-month anniversary of the funding date of each respective loan. 1.0% After the 48-month anniversary of the funding date of each respective loan. 0.0% (1) “Make-Whole Amount” is equal to the sum of the remaining scheduled interest payments through the 12-month anniversary of the closing date of each respective loa n. The following table summarizes activity within the Initial Term Loan for the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Initial draw $ 25,000 Debt issuance costs Cash issuance costs (2,593) Noncash issuance costs: Revenue base redemption liability (729) Warrant liability (811) Balance at April 30, 2024 $ 20,867 Amortization of debt issuance costs 237 PIK interest 151 Accretion of exit fee liability 31 Balance at June 30, 2024 $ 21,286 |
Convertible Preferred Stock (Ta
Convertible Preferred Stock (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Temporary Equity Disclosure [Abstract] | |
Schedule of Convertible Preferred Stock | The following table summarizes activity in Series A convertible preferred stock in the six months ended June 30, 2024. There was no activity in the six months ended June 30, 2023. Series Balance at Issuances Balance at Series A convertible preferred stock (assuming maximum conversion) 25,237,155 — 25,237,155 Total convertible preferred stock 25,237,155 — 25,237,155 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities (in common stock equivalent shares) have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported: June 30, 2024 2023 Preferred stock 25,237,155 15,522,792 Preferred stock warrants — 2,923,415 Common stock warrants 14,345,917 — Restricted stock units 544,988 — Options to purchase common stock 4,866,070 1,715,211 Shares issuable under the SEPA 4,510,704 — Total 49,504,834 20,161,418 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation Plan Balances | As of June 30, 2024, the balances under the two plans are below. June 30, 2024 Authorized Outstanding Available for Issue 2009 Plan 1,553,852 1,553,852 — 2023 Plan 7,969,775 3,857,206 4,112,569 Total 9,523,627 5,411,058 4,112,569 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 183 Months Ended | ||||||
Oct. 02, 2023 | Aug. 10, 2023 | Apr. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Nature of Business [Line Items] | ||||||||||
Issuance of stock | $ 3,602 | $ 3,141 | $ 7,315 | |||||||
Proceeds from business combination | $ 36,854 | |||||||||
Accumulated deficit | 265,928 | $ 265,928 | $ 248,377 | |||||||
Proceeds from the issuance of common stock | 6,743 | $ 0 | ||||||||
Proceeds from the exercise of stock options for common stock | 12 | 66 | ||||||||
Proceeds from lines of credit | 25,000 | 0 | ||||||||
Cash, cash equivalents and restricted cash, | $ 16,831 | $ 16,831 | $ 4,154 | $ 12,127 | $ 9,664 | |||||
Sale of stock (in shares) | 400,000 | 750,000 | ||||||||
Proceeds from sale of common stock | $ 3,602 | $ 6,743 | ||||||||
Loan Facility | Secured Debt | ||||||||||
Nature of Business [Line Items] | ||||||||||
Line of credit maximum borrowing capacity | $ 50,000 | |||||||||
Proceeds from lines of credit | 25,000 | |||||||||
Loan Facility, June 30, 2025 | Secured Debt | ||||||||||
Nature of Business [Line Items] | ||||||||||
Line of credit maximum borrowing capacity | 10,000 | |||||||||
Loan Facility, December 31, 2025 | Secured Debt | ||||||||||
Nature of Business [Line Items] | ||||||||||
Line of credit maximum borrowing capacity | $ 15,000 | |||||||||
Standby Equity Purchase Agreement | ||||||||||
Nature of Business [Line Items] | ||||||||||
Proceeds from the issuance of common stock | 6,743 | |||||||||
Sale of stock, authorized amount | $ 30,000 | $ 30,000 | ||||||||
Convertible notes and warrants | ||||||||||
Nature of Business [Line Items] | ||||||||||
Issuance of stock | 57,466 | |||||||||
Preferred stock | ||||||||||
Nature of Business [Line Items] | ||||||||||
Issuance of stock | $ 164,364 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) shares in Thousands, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Oct. 02, 2023 USD ($) | Aug. 10, 2023 shares | Oct. 31, 2023 | Jun. 30, 2024 USD ($) | Apr. 30, 2024 USD ($) | Dec. 31, 2023 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Derivative instrument, contingent consideration, liability, earnout period | 5 years | |||||
Purchase agreement period | 24 months | 24 months | ||||
Loan Facility, Initial Commitment Amount | Secured Debt | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Line of credit maximum borrowing capacity | $ 25,000 | |||||
Estimated dividend yield | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Contingent earnout liability, measurement input | 0 | 0 | ||||
Standby Equity Purchase Agreement | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Sale of stock, authorized amount | $ 30,000 | $ 30,000 | ||||
Contingent earnout liability | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Shares unvested (in shares) | shares | 3,125 |
Business Combination (Details)
Business Combination (Details) $ in Thousands | Aug. 10, 2023 USD ($) shares |
Reverse Recapitalization [Line Items] | |
Proceeds from transaction | $ 42,854 |
Proceeds from MTAC trust account | 2,704 |
Proceeds from private placement | 40,150 |
Expenses related to business combination | 1,742 |
Proceeds from business combination | 36,854 |
Transaction costs incurred | 6,069 |
Transaction costs paid from proceeds | $ 4,327 |
Exchange ratio (in shares) | shares | 0.02471853 |
Stock converted, reverse recapitalization (in shares) | shares | 21,999,886 |
MedTech Acquisition Corporation | |
Reverse Recapitalization [Line Items] | |
Expenses related to business combination | $ 6,000 |
Financial Instruments - Narrati
Financial Instruments - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2024 | Jun. 26, 2024 | May 24, 2024 | Apr. 30, 2024 | Dec. 31, 2023 | Oct. 02, 2023 | Aug. 10, 2023 | Dec. 17, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrants outstanding (in shares) | 14,345,917 | 14,215,112 | 14,266,605 | |||||
Exercise price of warrants (in dollars per share) | $ 11.50 | |||||||
Warrant and SEPA liabilities | $ 12,497 | $ 17,100 | $ 28,927 | |||||
Contingent earnout liability | 8,931 | 18,632 | $ 28,927 | |||||
SEPA derivative liability | 11,705 | 16,916 | ||||||
SEPA derivative liability | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
SEPA derivative liability | $ 394 | $ 185 | $ 183 | |||||
Public Warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrants outstanding (in shares) | 1,751,825 | 8,281,779 | 8,333,272 | |||||
Exercise price of warrants (in dollars per share) | $ 11.50 | |||||||
Warrant and SEPA liabilities | $ 2,855 | $ 1,500 | ||||||
Closing price (in dollars per share) | $ 0.18 | |||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 1 | |||||||
Number of warrants exchanged (in shares) | 6,529,954 | |||||||
Private Placement And Working Capital Warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrants outstanding (in shares) | 5,933,333 | |||||||
Private Placement Warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrants outstanding (in shares) | 4,428,648 | 4,933,333 | 4,933,333 | 4,933,333 | ||||
Warrant and SEPA liabilities | $ 7,219 | $ 888 | ||||||
Number of warrants exchanged (in shares) | 504,685 | |||||||
Working capital warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrants outstanding (in shares) | 1,000,000 | 1,000,000 | 1,000,000 | 1,000,000 | ||||
Warrant and SEPA liabilities | $ 1,630 | $ 180 | ||||||
Number of warrants exchanged (in shares) | 0 | |||||||
SPAC Warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Warrant and SEPA liabilities | 11,705 | $ 2,568 | ||||||
Initial OrbiMed Warrant | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Exercise price of warrants (in dollars per share) | $ 9.5562 | |||||||
Warrant and SEPA liabilities | $ 399 | $ 811 | ||||||
Warrants to purchase common stock (in shares) | 130,805 | |||||||
Public Warrants, Private Placement Warrants And Working Capital Warrants | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 0.27 | 0.30 | ||||||
Outstanding warrant liabilities | $ 11,924 |
Financial Instruments - Summary
Financial Instruments - Summary of Changes in Fair Value of Outstanding Warrant and Tranche Liabilities (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 16,916 | |
Change in Unrealized (Gains) Losses | 6,712 | |
Issuances (Settlements) | (11,923) | |
Ending balance | 11,705 | |
Level 2 | Public Warrants, Private Placement Warrants And Working Capital Warrants | ||
Equity, Fair Value Disclosure [Roll Forward] | ||
Beginning balance | 0 | |
Change in Unrealized (Gains) Losses | 0 | |
Issuances (Settlements) | 11,923 | |
Ending balance | 11,923 | |
Public Warrants | Level 1 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 9,855 | |
Change in Unrealized (Gains) Losses | 4,068 | |
Issuances (Settlements) | (11,068) | |
Ending balance | 2,855 | |
Private Placement Warrants | Level 2 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 5,871 | |
Change in Unrealized (Gains) Losses | 2,204 | |
Issuances (Settlements) | (855) | |
Ending balance | 7,220 | |
Working capital warrants | Level 2 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 1,190 | |
Change in Unrealized (Gains) Losses | 440 | |
Issuances (Settlements) | 0 | |
Ending balance | 1,630 | |
Contingent earnout liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 18,632 | |
Change in Unrealized (Gains) Losses | (9,701) | |
Issuances (Settlements) | 0 | |
Ending balance | 8,931 | |
SEPA derivative liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 185 | |
Change in Unrealized (Gains) Losses | 209 | |
Issuances (Settlements) | 0 | |
Ending balance | 394 | |
Initial OrbiMed Warrant liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Change in Unrealized (Gains) Losses | (413) | |
Issuances (Settlements) | 811 | |
Ending balance | 399 | |
Revenue base redemption liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Change in Unrealized (Gains) Losses | (13) | |
Issuances (Settlements) | 729 | |
Ending balance | $ 715 | |
Warrant liabilities | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 369 | |
Change in Unrealized (Gains) Losses | (1) | |
Issuances (Settlements) | (106) | |
Net Transfer In (Out) of Level 3 | 0 | |
Ending balance | 262 | |
Series B-2 tranche liabilities | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 4,702 | |
Change in Unrealized (Gains) Losses | (2,241) | |
Issuances (Settlements) | (1,502) | |
Net Transfer In (Out) of Level 3 | 0 | |
Ending balance | 959 | |
Series B-3 warrant liabilities | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 15,819 | |
Change in Unrealized (Gains) Losses | (1,248) | |
Issuances (Settlements) | 2,619 | |
Net Transfer In (Out) of Level 3 | 0 | |
Ending balance | $ 17,190 |
Cash, Cash Equivalents and Re_3
Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 16,481 | $ 11,777 | ||
Restricted cash (included in Other assets) | 350 | 350 | ||
Total cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows | $ 16,831 | $ 12,127 | $ 4,154 | $ 9,664 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 901 | $ 607 |
Finished goods | 2,542 | 2,055 |
Reserve for excess or obsolete inventory | 0 | (117) |
Inventory | $ 3,443 | $ 2,545 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 13 | $ 22 |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible asset, useful life | 20 years |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2024 | $ 25 | |
2025 | 51 | |
2026 | 51 | |
2027 | 51 | |
2028 | 51 | |
Thereafter | 884 | |
Intangible assets, net | $ 1,113 | $ 1,127 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued liabilities - clinical trials | $ 3,706 | $ 3,115 |
Accrued liabilities | 2,763 | 2,790 |
Accrued bonus | 1,664 | 3,736 |
Accrued vacation | 351 | 327 |
Accrued payroll | 386 | 557 |
Accrued employee benefits | 500 | 0 |
Accrued taxes | 37 | 31 |
Total accrued liabilities | $ 9,407 | $ 10,556 |
Contingent Earnout Liability -
Contingent Earnout Liability - Narrative (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Aug. 10, 2023 USD ($) trading_day $ / shares shares | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Derivative instrument, contingent consideration, liability, earnout period | 5 years | ||||
Warrant and SEPA liabilities | $ | $ 28,927 | $ 12,497 | $ 12,497 | $ 17,100 | |
Contingent earnout liability | $ | $ 28,927 | $ 8,931 | 8,931 | $ 18,632 | |
Change in fair value of warrants and SEPA liability | $ | $ (6,921) | $ 3,491 | |||
Estimated dividend yield | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Contingent earnout liability, measurement input | 0 | 0 | 0 | ||
Minimum | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout period, threshold trading days | trading_day | 20 | ||||
Maximum | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout period, threshold consecutive trading days | trading_day | 30 | ||||
Tranche One | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout shares vesting percentage | 0.25 | ||||
Earnout shares vesting requirement, weighted average price per share (in dollars per share) | $ / shares | $ 15 | ||||
Tranche Two | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout shares vesting percentage | 0.25 | ||||
Earnout shares vesting requirement, weighted average price per share (in dollars per share) | $ / shares | $ 20 | ||||
Tranche Three | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout shares vesting percentage | 0.25 | ||||
Earnout shares vesting requirement, weighted average price per share (in dollars per share) | $ / shares | $ 25 | ||||
Tranche Four | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Earnout shares vesting percentage | 0.25 | ||||
Earnout shares vesting requirement, weighted average price per share (in dollars per share) | $ / shares | $ 30 | ||||
Contingent earnout liability | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Shares unvested (in shares) | shares | 3,125 | ||||
Contingent earnout liability | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Change in fair value of warrants and SEPA liability | $ | $ 13,689 | $ 9,701 |
Contingent Earnout Liability _2
Contingent Earnout Liability - Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate (Details) | Jun. 30, 2024 $ / shares year | Dec. 31, 2023 $ / shares year |
Current stock price | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent earnout liability, measurement input | $ / shares | 5.52 | 8.45 |
Expected share price volatility | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent earnout liability, measurement input | 0.650 | 0.650 |
Risk-free interest rate | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent earnout liability, measurement input | 0.044 | 0.039 |
Expected term (years) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent earnout liability, measurement input | year | 4.11 | 4.60 |
Estimated dividend yield | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent earnout liability, measurement input | 0 | 0 |
Warrants - Schedule of Warrants
Warrants - Schedule of Warrants Outstanding (Details) - shares | Jun. 30, 2024 | May 24, 2024 | Dec. 31, 2023 | Aug. 10, 2023 |
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 14,345,917 | 14,215,112 | 14,266,605 | |
Public Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 1,751,825 | 8,281,779 | 8,333,272 | |
Private Placement Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 4,428,648 | 4,933,333 | 4,933,333 | 4,933,333 |
Working Capital Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 1,000,000 | 1,000,000 | 1,000,000 | 1,000,000 |
Initial OrbiMed Warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 130,805 | 0 | ||
Exchange Warrants (Equity-Classified) | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 7,034,639 | 0 |
Warrants - Narrative (Details)
Warrants - Narrative (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Jul. 02, 2024 shares | Jun. 30, 2024 USD ($) shares | Dec. 31, 2023 USD ($) shares | Jun. 30, 2024 USD ($) day $ / shares shares | Jun. 26, 2024 USD ($) shares | May 24, 2024 shares | Apr. 30, 2024 | Aug. 10, 2023 USD ($) $ / shares shares | Dec. 17, 2020 shares | |
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 14,345,917 | 14,215,112 | 14,345,917 | 14,266,605 | |||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 11.50 | ||||||||
Class of warrant or right, threshold number of days for warrants to be transferable | 30 days | ||||||||
Warrant and SEPA liabilities | $ | $ 12,497 | $ 17,100 | $ 12,497 | $ 28,927 | |||||
Issuance costs | $ | $ 1,699 | ||||||||
Subsequent Event | Common stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Common stock exchange for warrants (in shares) | 2,110,366 | ||||||||
Public Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 1,751,825 | 8,281,779 | 1,751,825 | 8,333,272 | |||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 1 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 11.50 | ||||||||
Warrants repurchased (in shares) | 51,493 | ||||||||
Payments for repurchase of warrants | $ | $ 20 | ||||||||
Warrants, term | 5 years | 5 years | |||||||
Class of warrant or right, redemption price (in dollars per share) | $ / shares | $ 0.01 | ||||||||
Warrant redemption condition, share price (in dollars per share) | $ / shares | $ 18 | ||||||||
Class of warrant or right, conversion terms, threshold trading days | day | 20 | ||||||||
Class of warrant or right, conversion terms, threshold consecutive trading days | day | 30 | ||||||||
Warrant and SEPA liabilities | $ | $ 2,855 | $ 2,855 | $ 1,500 | ||||||
Number of warrants exchanged (in shares) | 6,529,954 | ||||||||
Warrant holder support for Warrant Agreement | 0.788 | ||||||||
Public Warrants | Minimum | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Threshold number of business days before sending notice of redemption to warrant holders | day | 30 | ||||||||
Private Placement Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 4,428,648 | 4,933,333 | 4,428,648 | 4,933,333 | 4,933,333 | ||||
Warrant and SEPA liabilities | $ | $ 7,219 | $ 7,219 | $ 888 | ||||||
Number of warrants exchanged (in shares) | 504,685 | ||||||||
Warrant holder support for Warrant Agreement | 0.102 | ||||||||
Working Capital Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 1,000,000 | 1,000,000 | 1,000,000 | 1,000,000 | 1,000,000 | ||||
Warrant and SEPA liabilities | $ | $ 1,630 | $ 1,630 | $ 180 | ||||||
Number of warrants exchanged (in shares) | 0 | ||||||||
Initial OrbiMed Warrant liability | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 130,805 | 0 | 130,805 | ||||||
Warrants, term | 7 years | ||||||||
Warrants issued, delayed draw commitment amount, percentage | 0.050 | ||||||||
Purchase agreement, ownership limitation | 0.0999 | ||||||||
Public Warrants, Private Placement Warrants And Working Capital Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 0.27 | 0.30 | |||||||
Outstanding warrant liabilities | $ | $ 11,924 | ||||||||
Exchange Warrants (Equity-Classified) | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | 7,034,639 | 0 | 7,034,639 |
Warrants - Schedule of Warrant
Warrants - Schedule of Warrant Activity (Details) | 6 Months Ended |
Jun. 30, 2024 shares | |
Class of Warrant or Right [Roll Forward] | |
Warrants outstanding, beginning balance (in shares) | 14,215,112 |
Warrants outstanding, ending balance (in shares) | 14,345,917 |
Public Warrants | |
Class of Warrant or Right [Roll Forward] | |
Warrants outstanding, beginning balance (in shares) | 8,281,779 |
Exercises (in shares) | 0 |
Issuances (in shares) | 0 |
Retirements/Conversions (in shares) | (6,529,954) |
Warrants outstanding, ending balance (in shares) | 1,751,825 |
Private Placement Warrants | |
Class of Warrant or Right [Roll Forward] | |
Warrants outstanding, beginning balance (in shares) | 4,933,333 |
Exercises (in shares) | 0 |
Issuances (in shares) | 0 |
Retirements/Conversions (in shares) | (504,685) |
Warrants outstanding, ending balance (in shares) | 4,428,648 |
Working Capital Warrants | |
Class of Warrant or Right [Roll Forward] | |
Warrants outstanding, beginning balance (in shares) | 1,000,000 |
Exercises (in shares) | 0 |
Issuances (in shares) | 0 |
Retirements/Conversions (in shares) | 0 |
Warrants outstanding, ending balance (in shares) | 1,000,000 |
Exchange Warrants (Equity-Classified) | |
Class of Warrant or Right [Roll Forward] | |
Warrants outstanding, beginning balance (in shares) | 0 |
Exercises (in shares) | 0 |
Issuances (in shares) | 0 |
Retirements/Conversions (in shares) | 7,034,639 |
Warrants outstanding, ending balance (in shares) | 7,034,639 |
Warrants - Schedule of Fair Val
Warrants - Schedule of Fair Value Assumptions (Details) $ in Thousands | Jun. 30, 2024 USD ($) year $ / shares | Apr. 30, 2024 USD ($) $ / shares year | Dec. 31, 2023 USD ($) | Aug. 10, 2023 USD ($) |
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Warrant and SEPA liabilities | $ | $ 12,497 | $ 17,100 | $ 28,927 | |
Initial OrbiMed Warrant | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Warrant and SEPA liabilities | $ | $ 399 | $ 811 | ||
Expected term (years) | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | year | 5 | 5 | ||
Risk-free interest rate | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | 0.043 | 0.047 | ||
Expected volatility | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | 0.650 | 0.650 | ||
Dividend yield | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | 0 | 0 | ||
Exercise price | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | $ / shares | 9.56 | 9.56 | ||
Stock price | ||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||||
Derivative liability, measurement input | $ / shares | 5.52 | 9.31 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | ||||
Effective federal tax rate | 0% | 0% | ||
Income tax expense | $ 7 | $ 13 | $ 10 | $ 8 |
Dynavax Purchase (Details)
Dynavax Purchase (Details) - Dynavax Technologies $ in Thousands | 1 Months Ended | 6 Months Ended | |
Sep. 30, 2021 USD ($) | Jun. 30, 2024 USD ($) milestone | Dec. 31, 2020 USD ($) | |
Asset Acquisition [Line Items] | |||
Upfront payment | $ 9,000 | ||
Number of commercial milestones | milestone | 4 | ||
Maximum aggregate milestone payments per development milestone | $ 170,000 | ||
Royalties as a percentage of net sales, under sales threshold | 0.100 | ||
Royalties, sales threshold amount | $ 1,000,000 | ||
Royalties as a percentage of sales, over threshold amount | 0.120 | ||
Commercial Milestone | |||
Asset Acquisition [Line Items] | |||
Maximum aggregate milestone payments per development milestone | $ 80,000 | ||
Minimum | |||
Asset Acquisition [Line Items] | |||
Payments for milestone | $ 1,000 | 1,000 | |
Maximum | |||
Asset Acquisition [Line Items] | |||
Payments for milestone | $ 10,000 |
Standby Equity Purchase Agree_3
Standby Equity Purchase Agreement - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Oct. 02, 2023 USD ($) shares | Oct. 31, 2023 | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2024 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares | |
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Purchase agreement period | 24 months | 24 months | |||
Purchase agreement, number of trading days used for measurement of market price | 3 days | ||||
Standby equity purchase agreement, maximum allowable percentage of outstanding common stock | 0.1999 | ||||
SEPA derivative liability | $ 11,705 | $ 11,705 | $ 16,916 | ||
Unrealized loss | $ 6,712 | ||||
Sale of stock (in shares) | shares | 400,000 | 750,000 | |||
Proceeds from sale of common stock | $ 3,602 | $ 6,743 | |||
Expected draws | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Expected draws | 13,000 | 13,000 | 5,000 | ||
SEPA derivative liability | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
SEPA derivative liability | $ 183 | $ 394 | $ 394 | $ 185 | |
Unrealized loss | 209 | ||||
Standby Equity Purchase Agreement | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Sale of stock, authorized amount | $ 30,000 | $ 30,000 | |||
Purchase agreement, maximum shares allowed, percentage of average daily volume | 1 | ||||
Purchase agreement, number of days used for measurement of average daily trading volume | 10 days | ||||
Maximum shares of common stock allowed under Purchase Agreement (in shares) | shares | 1,000,000 | ||||
Purchase agreement, sales price, percentage of market price | 0.960 | ||||
Purchase agreement, sales price, percentage of market price during three consecutive trading days | 0.970 | ||||
Purchase agreement, ownership limitation | 0.0499 | ||||
Common stock, shares authorized, standby equity purchase agreement (in shares) | shares | 5,260,704 |
Standby Equity Purchase Agree_4
Standby Equity Purchase Agreement - Expected Volatility (Details) $ in Thousands | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) |
Expected draws | ||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||
Derivative liability, measurement input | 13,000 | 5,000 |
Expected probability of draws | ||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||
Derivative liability, measurement input | 0.90 | |
Expected probability of draws | Minimum | ||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||
Derivative liability, measurement input | 0.90 | |
Expected probability of draws | Maximum | ||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||
Derivative liability, measurement input | 1 | |
Risk-free interest rate | ||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | ||
Derivative liability, measurement input | 0.055 | 0.054 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 6 Months Ended | ||
Apr. 30, 2024 | Apr. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Instrument [Line Items] | ||||||
Proceeds from lines of credit | $ 25,000,000 | $ 0 | ||||
Paid in kind interest, term | 15 months | |||||
Debt issuance costs | 2,593,000 | 0 | ||||
Warrant liability | $ 811,000 | $ 811,000 | ||||
Revenue base redemption feature, amount | $ 729,000 | $ 729,000 | ||||
Cash paid for interest expense | $ 445,000 | |||||
Amortization of debt issuance costs | $ 267,000 | $ 0 | ||||
Initial OrbiMed Warrant liability | ||||||
Debt Instrument [Line Items] | ||||||
Warrants issued, delayed draw commitment amount, percentage | 0.050 | 0.050 | ||||
Earnout shares vesting requirement, vesting period | 7 years | 7 years | ||||
Loan Facility | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Line of credit maximum borrowing capacity | $ 50,000,000 | $ 50,000,000 | ||||
Proceeds from lines of credit | $ 25,000,000 | |||||
Default rate | 4% | 4% | ||||
SOFR floor | 0.040 | 0.040 | ||||
Paid-in-kind interest | 3.50% | 3.50% | ||||
Exit fee percentage | 0.040 | 0.040 | ||||
Commitment fee percentage | 2% | |||||
Undrawn fee, percentage | 0.25% | |||||
Administrative fee | $ 10,000 | $ 10,000 | ||||
Loan Facility | Secured Debt | Secured Overnight Financing Rate (SOFR) | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 8.50% | |||||
Loan Facility, Initial Commitment Amount | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Line of credit maximum borrowing capacity | $ 25,000,000 | 25,000,000 | ||||
Proceeds from lines of credit | 25,000,000 | |||||
Interest expense | 596,000 | |||||
PIK interest | $ 151,000 | 151,000 | ||||
Amortization of debt issuance costs | 237,000 | 237,000 | ||||
Accretion of exit fee liability | $ 31,000 | $ 31,000 | ||||
Loan Facility, June 30, 2025 | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Line of credit maximum borrowing capacity | 10,000,000 | 10,000,000 | ||||
Product revenue base, minimum amount required | 30,000,000 | 30,000,000 | ||||
Loan Facility, December 31, 2025 | Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Line of credit maximum borrowing capacity | 15,000,000 | 15,000,000 | ||||
Product revenue base, minimum amount required | $ 50,000,000 | $ 50,000,000 |
Debt - Product Revenue Base Red
Debt - Product Revenue Base Redemption Feature (Details) - Secured Debt $ in Thousands | Apr. 30, 2024 USD ($) |
September 30, 2024 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | $ 22,300 |
December 31, 2024 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 26,200 |
March 31, 2025 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 29,600 |
June 30, 2025 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 33,400 |
September 30, 2025 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 37,800 |
December 31, 2025 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 42,700 |
March 31, 2026 | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | 46,400 |
June 30, 2026 and thereafter | |
Debt Instrument [Line Items] | |
Product revenue base, minimum amount required | $ 50,000 |
Debt - Prepayment Premium (Deta
Debt - Prepayment Premium (Details) - Secured Debt | Apr. 30, 2024 |
Within 12 Months | |
Debt Instrument [Line Items] | |
Debt instrument, prepayment premium rate | 0.030 |
12 to 24 Months | |
Debt Instrument [Line Items] | |
Debt instrument, prepayment premium rate | 0.030 |
24 to 36 Months | |
Debt Instrument [Line Items] | |
Debt instrument, prepayment premium rate | 0.020 |
36 to 48 Months | |
Debt Instrument [Line Items] | |
Debt instrument, prepayment premium rate | 0.010 |
After 48 Months | |
Debt Instrument [Line Items] | |
Debt instrument, prepayment premium rate | 0 |
Debt - Initial Term Loan Activi
Debt - Initial Term Loan Activity (Details) - USD ($) $ in Thousands | 2 Months Ended | 3 Months Ended | 6 Months Ended | ||
Apr. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Instrument [Line Items] | |||||
Proceeds from the issuance of debt | $ 25,000 | $ 0 | |||
Debt issuance costs | (2,593) | 0 | |||
Revenue base redemption liability | $ (729) | ||||
Warrant liability | (811) | ||||
Debt Instrument, Activity [Roll Forward] | |||||
Amortization of debt issuance costs | 267 | $ 0 | |||
Loan Facility, Initial Commitment Amount | Secured Debt | |||||
Debt Instrument [Line Items] | |||||
Proceeds from the issuance of debt | 25,000 | ||||
Debt Instrument, Activity [Roll Forward] | |||||
Long-term debt, beginning balance | $ 20,867 | ||||
Amortization of debt issuance costs | 237 | $ 237 | |||
PIK interest | 151 | 151 | |||
Accretion of exit fee liability | 31 | 31 | |||
Long-term debt, ending balance | $ 20,867 | $ 21,286 | $ 21,286 | $ 21,286 |
Convertible Preferred Stock - N
Convertible Preferred Stock - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Aug. 10, 2023 | Jun. 30, 2024 | Dec. 31, 2023 | |
Temporary Equity [Line Items] | |||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |
Preferred stock available for future issuance (in shares) | 5,984,998 | ||
Undeclared cumulative dividends | $ 2,860 | ||
Automatic conversion, anniversary | 4 years | ||
Conversion price, first automatic reset | 18 months | ||
Conversion price, second automatic reset | 47 months | ||
Series A Convertible Preferred Stock, floor conversion price (in dollars per share) | $ 2.10 | ||
Number of trading days, VWAP | 10 days | ||
Liquidation preference (in dollars per share) | $ 10 | $ 10 | |
Series A Convertible Preferred Stock | |||
Temporary Equity [Line Items] | |||
Issuances (in shares) | 4,015,002 | ||
Original issue price (in dollars per share) | $ 10 | ||
Proceeds from the issuance of preferred stock | $ 40,150 | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | ||
Preferred stock, dividend rate, percentage | 8% | 8% | |
Liquidation preference (in dollars per share) | $ 10 |
Convertible Preferred Stock - S
Convertible Preferred Stock - Summary of Convertible Preferred Stock (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |
Convertible preferred stock, beginning balance | $ 25,237,155 |
Issuances | 0 |
Convertible preferred stock, ending balance | 25,237,155 |
Series A Convertible Preferred Stock | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |
Convertible preferred stock, beginning balance | 25,237,155 |
Issuances | 0 |
Convertible preferred stock, ending balance | $ 25,237,155 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 49,504,834 | 20,161,418 |
Preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 25,237,155 | 15,522,792 |
Preferred stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 2,923,415 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 14,345,917 | 0 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 544,988 | 0 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,866,070 | 1,715,211 |
Shares issuable under the SEPA | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,510,704 | 0 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jan. 01, 2024 shares | Jun. 30, 2024 USD ($) plan $ / shares shares | Dec. 31, 2023 shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of equity incentive plans | plan | 2 | ||
Options and RSU's outstanding (in shares) | 9,523,627 | ||
Additional number of shares authorized (in shares) | 2,385,694 | ||
Exercise of options (in shares) | 927 | ||
Options granted (in shares) | 1,307,613 | ||
Options, weighted average fair value (in dollars per share) | $ / shares | $ 9.11 | ||
Stock options exercise price, percentage of fair value | 100% | ||
Increase in common stock reserve for future issuance (in shares) | 954,278 | ||
2009 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options issued (in shares) | 1,489,679 | ||
Stock options outstanding (in shares) | 1,489,679 | ||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||
Unrecognized compensation expense, options | $ | $ 758 | ||
Unrecognized compensation expense, RSUs | $ | $ 499 | ||
Unrecognized compensation expense, recognition period | 1 year 4 months 24 days | ||
Options and RSU's outstanding (in shares) | 1,553,852 | ||
2009 Plan | Minimum | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share-based payment arrangement, contractual term | 1 year | ||
2009 Plan | Maximum | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share-based payment arrangement, contractual term | 4 years | ||
2023 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options issued (in shares) | 3,376,391 | ||
Stock options outstanding (in shares) | 3,376,391 | ||
Unrecognized compensation expense, options | $ | $ 13,175 | ||
Unrecognized compensation expense, recognition period | 3 years 3 months 18 days | ||
Options and RSU's outstanding (in shares) | 7,970,702 | 7,969,775 | 5,585,008 |
Share reserve increase, number of years | 10 years | ||
Share reserve increase, percentage of common stock | 5% | ||
Restricted stock units | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
RSUs granted (in shares) | 480,815 | ||
RSU weighted average fair value (in dollars per share) | $ / shares | $ 9.48 | ||
Restricted stock units | 2009 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Restricted stock units outstanding (in shares) | 64,173 | ||
Restricted stock units issued (in shares) | 64,173 | ||
Restricted stock units | 2023 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Restricted stock units outstanding (in shares) | 480,815 | ||
Restricted stock units issued (in shares) | 480,815 | ||
Unrecognized compensation expense | $ | $ 3,052 | ||
Employee Stock | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Common stock reserved for future issuance (in shares) | 2,350,530 | 1,396,252 | |
Share-based compensation arrangement by share-based payment award, automatic increase period | 10 years | ||
Share-based compensation arrangement by share-based payment award, automatic increase, percentage of total shares | 0.02 | ||
Share-based compensation arrangement by share-based payment award, automatic increase, percentage of initial share reserve | 2 | ||
Shares purchased in ESPP offering (in shares) | 41,663 | ||
Value of shares purchased in ESPP offering | $ | $ 195 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - shares | Jun. 30, 2024 | Jan. 01, 2024 | Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Authorized (in shares) | 9,523,627 | ||
Outstanding (in shares) | 5,411,058 | ||
Available for Issue (in shares) | 4,112,569 | ||
2009 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Authorized (in shares) | 1,553,852 | ||
Outstanding (in shares) | 1,553,852 | ||
Available for Issue (in shares) | 0 | ||
2023 Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Authorized (in shares) | 7,969,775 | 7,970,702 | 5,585,008 |
Outstanding (in shares) | 3,857,206 | ||
Available for Issue (in shares) | 4,112,569 |
Leases (Details)
Leases (Details) $ in Thousands | 6 Months Ended | |
Jul. 17, 2024 renewal_option | Jun. 30, 2024 USD ($) renewal_option lease | |
Lessee, Lease, Description [Line Items] | ||
Number of leases | lease | 4 | |
Westminster Facility | ||
Lessee, Lease, Description [Line Items] | ||
Number of lease renewal options | 2 | |
Lease renewal term | 5 years | |
Rent payments | $ | $ 1,524 | |
Westminster Facility | Subsequent Event | ||
Lessee, Lease, Description [Line Items] | ||
Number of lease renewal options | 2 | |
Lease renewal term | 5 years | |
Number of lease renewal options exercised | 1 | |
Bannockburn Facility | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 3 years | |
Cranston Facility | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 2 years |