UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period from ___________ to ___________
Commission File Number:
(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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Number of shares of the registrant’s common shares outstanding at April 30, 2025:
AKOYA BIOSCIENCES, INC.
TABLE OF CONTENTS
Akoya Biosciences, Inc.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this report other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in this report and in other documents we file with the Securities and Exchange Commission (the “SEC”) from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this report represent our views as of the date of this report. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
Unless otherwise stated or the context otherwise indicates, references to “Akoya,” “we,” “us,” “our” and similar references refer to Akoya Biosciences, Inc. and its consolidated subsidiary.
This report contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to, including logos, artwork and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
1
AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| March 31, 2025 |
| December 31, 2024 | |||
(unaudited) | ||||||
Assets |
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Current assets |
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Cash and cash equivalents | $ | | $ | | ||
Marketable securities | | | ||||
Accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Restricted cash |
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Demo inventory, net |
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Intangible assets, net |
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Goodwill |
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Operating lease right of use assets, net | | | ||||
Financing lease right of use assets, net | | | ||||
Other assets |
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Total assets | $ | | $ | | ||
Liabilities and Stockholders’ (Deficit) Equity |
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Current liabilities |
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Accounts payable | $ | | $ | | ||
Accrued expenses and other current liabilities |
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Current portion of operating lease liabilities | | | ||||
Current portion of financing lease liabilities | | | ||||
Deferred revenue |
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Current portion of long-term debt, net of debt discount | | — | ||||
Total current liabilities |
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Deferred revenue, net of current portion |
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Long-term debt, net of current portion and debt discount |
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Deferred tax liability, net |
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Operating lease liabilities, net of current portion | | | ||||
Financing lease liabilities, net of current portion | | | ||||
Contingent consideration liability, net of current portion |
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Other liabilities | | | ||||
Total liabilities |
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Stockholders’ (deficit) equity: |
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Preferred Stock, $ | ||||||
Common Stock, $ |
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Additional paid in capital |
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Accumulated deficit |
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Accumulated other comprehensive (loss) income | ( | | ||||
Total stockholders’ (deficit) equity |
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Total liabilities and stockholders’ (deficit) equity | $ | | $ | |
See accompanying notes to consolidated financial statements.
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AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(in thousands except share & per share data)
Three months ended | ||||||
March 31, | March 31, | |||||
| 2025 |
| 2024 | |||
Revenue: |
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Product revenue | $ | | $ | | ||
Service and other revenue |
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Total revenue |
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Cost of goods sold: |
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Cost of product revenue | | | ||||
Cost of service and other revenue | | | ||||
Total cost of goods sold | | | ||||
Gross profit | | | ||||
Operating expenses: |
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Selling, general and administrative |
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Research and development |
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Change in fair value of contingent consideration |
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Impairment |
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Restructuring | — | | ||||
Total operating expenses |
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Loss from operations |
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Other income (expense): |
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Interest expense |
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Interest income | | | ||||
Other expense, net |
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Loss before provision for income taxes | ( | ( | ||||
Provision for income taxes |
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Net loss | $ | ( | $ | ( | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | ( | $ | ( | ||
Weighted-average shares outstanding, basic and diluted |
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See accompanying notes to consolidated financial statements.
3
AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)
(in thousands)
Three months ended | ||||||
March 31, | March 31, | |||||
| 2025 |
| 2024 | |||
Net loss | $ | ( | $ | ( | ||
Other comprehensive loss: | ||||||
Unrealized loss on marketable securities | ( | ( | ||||
Total other comprehensive loss | ( | ( | ||||
Comprehensive loss | $ | ( | $ | ( |
See accompanying notes to consolidated financial statements.
4
AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ (DEFICIT) EQUITY (Unaudited)
(in thousands, except share data)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity (Deficit) | ||||||
Balance at December 31, 2024 |
| | $ | |
| $ | | $ | ( | $ | | $ | | ||||
Exercise of stock options |
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Vesting of restricted stock units | | — | ( | — | — | ( | |||||||||||
Net loss | — | — | — | ( | — | ( | |||||||||||
Other comprehensive loss |
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Stock-based compensation |
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Balance at March 31, 2025 | | $ | | $ | | $ | ( | $ | ( | $ | ( |
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||
Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | |||||||
Balance at December 31, 2023 |
| | $ | |
| $ | | $ | ( | $ | — | $ | | ||||
Exercise of stock options |
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Vesting of restricted stock units | | — | ( | — | — | ( | |||||||||||
Net loss |
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Other comprehensive loss | — | — | — | — | ( | ( | |||||||||||
Stock-based compensation |
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Balance at March 31, 2024 | | $ | | $ | | $ | ( | $ | ( | $ | |
See accompanying notes to consolidated financial statements.
5
AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(in thousands)
Three months ended | ||||||
March 31, | March 31, | |||||
| 2025 |
| 2024 | |||
Operating activities |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Non-cash interest expense |
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Stock-based compensation expense |
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Deferred taxes |
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Change in fair value of contingent consideration |
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Credit losses on accounts receivable | | | ||||
Net accretion of marketable securities | ( | ( | ||||
Operating lease right of use assets | | | ||||
Provision for excess and obsolete inventories | | | ||||
Impairment | — | | ||||
Changes in operating assets and liabilities: |
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Accounts receivable, net |
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Prepaid expenses and other assets |
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Inventories, net |
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Accounts payable |
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Accrued expenses and other liabilities |
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Operating lease liabilities | ( | ( | ||||
Deferred revenue |
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Net cash used in operating activities |
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Investing activities |
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Purchases of property and equipment |
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Purchases of marketable securities | ( | ( | ||||
Maturities of marketable securities | | — | ||||
Net cash provided by (used in) investing activities |
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Financing activities |
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Proceeds from stock option exercises |
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Settlement of restricted stock units for tax withholding obligations | ( | ( | ||||
Principal payments on financing leases | ( | ( | ||||
Payments of deferred offering costs |
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Net cash used in financing activities |
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Net increase (decrease) in cash, cash equivalents, and restricted cash |
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Cash, cash equivalents, and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at end of period | $ | | $ | | ||
Supplemental disclosures of cash flow information |
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Cash paid for interest | $ | | $ | | ||
Cash paid for income taxes | $ | — | $ | — | ||
Supplemental disclosures of non-cash activities |
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Purchases of property and equipment included in accounts payable and accrued expenses | $ | | $ | |
See accompanying notes to consolidated financial statements.
6
AKOYA BIOSCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share data)
(1) The company and basis of presentation
Description of business
Akoya Biosciences, Inc. (“Akoya” or the “Company”) is a life sciences technology company, founded on November 13, 2015 as a Delaware corporation with operations based in Marlborough, Massachusetts, delivering spatial biology solutions focused on transforming discovery, clinical research and diagnostics. Spatial biology refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Through Akoya’s PhenoCycler (formerly CODEX) and PhenoImager (formerly Phenoptics) platforms, reagents, software and services, the Company offers end-to-end solutions to perform tissue analysis and spatial phenotyping across the full continuum from discovery through translational and clinical research and diagnostics.
On September 28, 2018, the Company acquired the commercial Quantitative Pathology Solutions (“QPS”) division of Perkin Elmer, Inc. (“PKI”), subsequently known as Revvity, Inc. (“Revvity”), for multiplex immunofluorescence, with the aim of providing consumers with a full suite of end-to-end solutions for high parameter tissue analysis. The QPS technology offers pathology solutions for cancer immunology and immunotherapy research, including advanced multiplex immunochemistry staining kits, multispectral imaging and whole side scanning instruments, and image analysis software. The Company’s combined portfolio of complementary technologies aims to fuel groundbreaking advancements in cancer immunology, immunotherapy, neurology and a wide range of other applications. The Company sells into
Principles of consolidation
The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Akoya Biosciences UK Ltd. (“Akoya UK”). All intercompany balances and transactions have been eliminated in consolidation.
Unaudited interim financial information
The accompanying consolidated balance sheet as of March 31, 2025, the consolidated statements of operations, the consolidated statements of comprehensive loss and the consolidated statements of stockholders’ (deficit) equity for the three months ended March 31, 2025 and 2024, and the consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025, the results of its operations for the three months ended March 31, 2025 and 2024, and cash flows for the three months ended March 31, 2025 and 2024. The financial data and other information disclosed in these notes related to the three months ended March 31, 2025 and 2024 are also unaudited. The results for the three months ended March 31, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period. The consolidated balance sheet as of December 31, 2024 included herein was derived from the audited consolidated financial statements as of that date. These unaudited consolidated financial statements should be read in conjunction with the Company’s audited consolidated
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financial statements and the notes thereto for the year ended December 31, 2024 included in the Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 17, 2025.
Liquidity and going concern
The Company is subject to a number of risks similar to other commercial-stage life sciences companies, including, but not limited to, its ability to develop and achieve market acceptance of its products and potential products, successfully compete with its competitors, protect its proprietary technology, and raise additional capital when and as needed.
At March 31, 2025, the Company had cash, cash equivalents, and marketable securities of $
In the event the merger contemplated under the Amended and Restated Agreement and Plan of Merger between the Company, Quanterix Corporation, and Wellfleet Merger Sub, Inc., which is further discussed in Note 2 – Merger, is not consummated, based on the Company’s current operating plan, the Company does not expect to maintain compliance with certain financial covenants at July 31, 2025 under its debt financing with Midcap Financial Trust (the “Midcap Trust Term Loan”). In such event, the Company would intend to seek a waiver, refinance the outstanding borrowings or otherwise mitigate these concerns with Midcap Financial Trust (“Midcap”) or another lender. There can be no assurance that a waiver will be granted or that the Company will be able to refinance the amounts outstanding, and in such an event, the lender may exercise any and all of its rights and remedies provided for under the Midcap Trust Term Loan.
As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern for the next twelve months following the date that these consolidated financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
(2) Merger
On April 28, 2025, the Company entered into an Amended and Restated Agreement and Plan of Merger (the “Merger Agreement”) with Quanterix Corporation, a Delaware corporation (“Quanterix”), and Wellfleet Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Quanterix (“Merger Sub”), pursuant to which, subject to the terms and conditions set forth therein, Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving such Merger as a wholly owned subsidiary of Quanterix. The Merger Agreement amends and restates in its entirety the Agreement and Plan of Merger (the “Original Merger Agreement”) entered into by the Company, Quanterix and Merger Sub on January 9, 2025. Under the Merger Agreement, the Company and Quanterix have agreed to revise certain terms of the Original Merger Agreement to provide that, at the effective time of the Merger (the “Effective Time”), each share of common stock, par value $
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the “Per Share Stock Consideration”) and, if applicable, cash in lieu of fractional shares, subject to any applicable withholding and; (b) $
The Merger Agreement also provides that, in connection with the consummation of the Merger, as contemplated by the Merger Agreement, (i) the aggregate number of shares of Quanterix Common Stock to be issued by Quanterix will not exceed
The Merger Agreement provides that, prior to the Effective Time, the board of directors of the Company will nominate two directors in replacement of two of the existing members of Quanterix’s board of directors (who must be from different classes of directors in Quanterix’s board of directors), who would resign as directors of Quanterix immediately prior to the Effective Time. The remaining members of the board of directors of Quanterix are expected to continue serving in such positions.
The obligation of the Company and Quanterix to consummate the transaction contemplated by the Merger Agreement is subject to the satisfaction or waiver of a number of customary conditions, including: (i) the adoption of the Merger Agreement by the Company’s stockholders; (ii) Quanterix’s registration statement on Form S-4 (File No. 333-284932) having become effective after the filing of any required post-effective amendment as may be necessary in order to reflect the revised terms of the Merger as contemplated in the Merger Agreement, and such registration statement not being subject to any stop order or action by the SEC seeking any stop order; (iii) the waiting period applicable to the Merger under the antitrust laws of the United States having expired or been terminated (which condition has already been satisfied based on the applicable filings made by Quanterix and the Company with respect to the transaction contemplated in the Original Merger Agreement); (iv) the absence of laws or orders restraining the consummation of the Merger; and (v) the submission by Quanterix to Nasdaq of a notification of the shares Quanterix Common Stock to be issued in connection with the Merger.
Each of the Company and Quanterix have made customary representations, warranties and covenants. Consummation of the Merger is subject to certain customary closing conditions.
The Merger Agreement contains customary mutual termination rights for the Company and Quanterix, including (i) if the Merger is not completed by August 31, 2025, (ii) in the event that a governmental authority issues a final order or enacts a law that permanently restrains, enjoins, makes illegal or prohibits the Merger or the other transactions contemplated in the Merger Agreement and (iii) in the event that the stockholders of the Company, at a meeting duly convened (or at any adjournment or postponement thereof), do not vote in favor of the adoption of the Merger Agreement. Each party may also terminate the Merger Agreement if the other party breaches its covenants, obligations, representations or warranties contained in the Merger Agreement in a manner that would result in a failure to satisfy the closing conditions relating to such covenants, obligations, representations or warranties.
Quanterix may also terminate the Merger Agreement (i) if the board of directors of the Company changes its recommendation with respect to the adoption thereof by the the Company’s stockholders and (ii) if the Company materially breaches its obligations in the Merger Agreement with respect to no solicitation or negotiations relating to alternative transactions, as described above. In addition, the Company may terminate the Merger Agreement if the board of directors of the Company authorizes entry into a definitive agreement relating to a Superior Proposal (as defined in the Merger Agreement).
Under the Merger Agreement, the Company will be required to pay a termination fee to Quanterix equal to $
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(iii) the board of directors of the Company having changed its recommendation that the Company’s stockholders vote to approve the adoption of the Merger Agreement or (iv) within 12 months of certain termination events, the Company having consummated or entered into a definitive agreement relating to certain alternative transactions (which alternative transaction is consummated).
The transaction is expected to close in the second quarter of 2025, assuming satisfaction of all conditions to the Merger.
On April 2, 2025, the Company entered into a securities purchase agreement (the “Original Securities Purchase Agreement”) with Quanterix, pursuant to which the Company will issue and sell to Quanterix from time to time, in a private placement, one or more convertible promissory notes having an aggregate principal amount of up to $
Any Convertible Notes issued under the SPA will mature on the earliest to occur of (i) the 91st day following the earlier of (a) November 1, 2027 and (b) the date that the Company’s indebtedness under the Midcap Trust Term Loan is repaid in full and all commitments under such documents have been terminated and (ii) subject to the terms of the Subordination Agreement (as defined below), any acceleration of the Convertible Notes. Any Convertible Note issued under the SPA will bear interest at a rate per annum equal to the SOFR interest rate plus an applicable margin specified in the Convertible Note to, but excluding, the date of repayment or conversion of the Convertible Note. Interest on the Convertible Notes will be paid in arrears on the first day of each month and on the maturity date of the Convertible Notes. Subject to the terms of the Subordination Agreement, any interest payments will be made exclusively to Quanterix in cash.
If drawn, the Convertible Notes will be convertible at the election of Quanterix during the period beginning on the date, if any, that the Merger Agreement is terminated and ending on the maturity date of the Convertible Notes into shares of common stock, par value $
The Convertible Notes prohibit conversion if it would result in the issuance of more than
At such time as the Company draws any funds and thereby issues any Convertible Notes, the Company, Quanterix, and Midcap Financial Trust will enter into a subordination agreement (the “Subordination Agreement”), pursuant to which the Company and Quanterix will agree, among other things, that the Convertible Notes will be subordinate to any debt outstanding and obligations owing under the Midcap Trust Term Loan.
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(3) Summary of significant accounting policies
Significant accounting policies
The Company’s significant accounting policies are disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC and have not materially changed during the three months ended March 31, 2025.
Revenue recognition
The Company follows ASC 606, Revenue from Contracts with Customers (“ASC 606”).
The Company generates revenue from the sale and installation of instruments, related warranty services, reagents, software (both company-owned and with third parties), and laboratory services. Pursuant to ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for these goods and services.
To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of Topic 606, the Company performs the following five steps: (i) identification of the customer contract; (ii) identification of the performance obligations; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer.
The Company evaluates all promised goods and services within a customer contract and determines which of those are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract.
Most of the Company’s contracts with customers contain multiple performance obligations (i.e., sale of an instrument and warranty services). For these contracts, the Company accounts for individual performance obligations separately if they are distinct (i.e. capable of being distinct and separable from other promises in the contract). The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. Excluded from the transaction price are sales tax and other similar taxes which are presented on a net basis.
In order to determine the stand-alone selling price, the Company conducts a periodic analysis to determine whether various goods or services have an observable stand-alone selling price as well as to identify significant changes to current stand-alone selling prices. If the Company does not have an observable stand-alone selling price for a particular good or service, then the stand-alone selling price for that particular good or service is estimated using an approach that maximizes the use of observable inputs. The Company’s process for determining stand-alone selling price requires judgment and considers multiple factors that are reasonably available and maximizes the use of observable inputs that may vary over time depending upon the unique facts and circumstances related to each performance obligation. The Company believes that this method results in an estimate that represents the price the Company would charge for the product offerings if they were sold separately.
Taxes, such as sales, value-added and other taxes, collected from customers concurrent with revenue generating activities and remitted to governmental authorities are not included in revenue. Shipping and handling costs associated with outbound freight are accounted for as a fulfillment cost and are included in cost of sales.
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Product Revenue
Product revenue is generated by the sale of instruments and consumable reagents predominantly through the Company’s direct sales force in the United States and in geographic regions outside the United States. The Company generally does not offer product return or exchange rights (other than those relating to defective goods under warranty) or price protection allowances to its customers. When an instrument is purchased by a customer, the Company recognizes revenue when the related performance obligation is satisfied (i.e. when the control of an instrument has passed to the customer). Revenue from the sale of consumables is recognized upon shipment to the customer. The Company’s perpetual software licenses generally have significant stand-alone functionality to the customer upon delivery and are considered to be functional intellectual property. The Company’s perpetual software licenses are considered distinct performance obligations, and revenue allocated to the software license is typically recognized upon provision of the license/software code to the customer (i.e., when the software is available for access and download by the customer).
Service and Other Revenue
Product sales of instruments include a service-based warranty typically for
following the installation of the purchased instrument, and in many cases an extended warranty which generally have terms ranging from to additional years. These are separate performance obligations as they are service-based warranties and are recognized on a straight-line basis over the service delivery period. After completion of the service period, customers have an option to renew or extend the warranty services, typically for additional periods in exchange for additional consideration. The extended warranties are also service-based warranties that represent separate purchasing decisions. The Company recognizes revenue allocated to the extended warranty performance obligation on a straight-line basis over the service delivery period. Revenue from separately charged installation services is recognized upon completion of the installation process. Additionally, the Company provides laboratory services, in which revenue is recognized as services are performed. For laboratory services, the Company generally uses the output method to measure the extent of progress towards completion of the performance obligation. For companion diagnostic development, the Company generally uses the cost-to-cost approach to measure the extent of progress towards completion of the performance obligation because the Company believes it best depicts the transfer of assets to the customer. Under the output method, the extent of progress towards completion is measured based on the value of the services transferred to date relative to the remaining services promised under the contract. Under the cost-to-cost measure approach, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs at completion of the performance obligation. Revenues are recorded proportionally as costs are incurred. The Company records shipping and handling billed to customers as service and other revenue and the related costs in cost of service and other revenue in the consolidated statements of operations.In June 2022, the Company entered into a Companion Diagnostic Agreement (the “Acrivon Agreement”) with Acrivon Therapeutics, Inc. (“Acrivon”) to co-develop, validate, and commercialize Acrivon’s OncoSignature® test. On December 4, 2023, the Company amended the Acrivon Agreement, which expanded the scope of work and increased total development milestone payments to an aggregate of $
The Acrivon Agreement is in the scope of ASC 606, Revenue from Contracts with Customers. The Company concluded that the Acrivon Agreement contains one performance obligation for certain development services, since the underlying elements are inputs to a single development service and are not distinct within the context of the contract. Additional development services in the Acrivon Agreement were deemed to be an option, due to certain contingencies
12
with significant uncertainty. The Company will recognize revenue over time for the transaction price in an amount proportional to the expenses incurred and the total estimated expenses to satisfy its performance obligation.
The costs incurred by the Company under this arrangement are included as research and development expenses in the Company’s consolidated statements of operations as these costs are related to the development of new services and technology to be owned and offered by the Company.
Disaggregation of Revenue
The Company disaggregates revenue from contracts with customers by type of products, and between instrument warranty and service and other revenue, as it best depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors. The following table disaggregates the Company’s revenue by major source:
Three months ended | ||||||
| March 31, 2025 |
| March 31, 2024 | |||
Revenue |
|
|
|
| ||
Product revenue |
|
|
|
| ||
Instruments | $ | | $ | | ||
Consumables |
| |
| | ||
Standalone software products |
| |
| | ||
Total product revenue | $ | | $ | | ||
Service and other revenue | ||||||
Service and other revenue | $ | | $ | | ||
Instrument warranty | | | ||||
Total service and other revenue | $ | | $ | | ||
Total revenue | $ | | $ | |
Significant Judgments
The Company’s contracts with customers often include promises to transfer multiple products and services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together requires significant judgment. Once the Company determines the performance obligations, the Company determines the transaction price, which includes estimating the amount of variable consideration, based on the most likely amount, to be included in the transaction price, if any. The Company then allocates the transaction price to each performance obligation in the contract based on a relative standalone selling price method. The corresponding revenue is recognized as the related performance obligations are satisfied as discussed in the revenue categories above.
Judgment is required to determine the standalone selling price for each distinct performance obligation. The Company determines standalone selling price based on the price at which the performance obligation in the contract (i.e. instrument, service warranty, installation) would be sold separately. As the first-year warranty for each instrument is embedded in the instrument price, the amount allocated to the first-year warranty has been determined based on the separately identifiable price of the Company’s extended warranty offering when it is sold on a renewal basis.
If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and the expected costs and margin related to the performance obligations. Contracts in which only one performance obligation is identified (i.e., consumables and standalone software products) do not require allocation of the transaction price.
Contract Assets and Liabilities
The Company’s contract assets consist of revenues recognized, but not yet invoiced to customers for lab services, companion diagnostic development, and instruments. The Company classifies contract assets in accounts receivable. Contract assets are classified as current or noncurrent based on timing of when the Company expects to invoice the
13
customer. The Company recorded $
The Company’s contract liabilities consist of upfront payments for service-based warranties on instrument sales, as well as lab services. The Company classifies contract liabilities associated with service based warranties in deferred revenue, and contract liabilities associated with lab services in accrued expenses. Contract liabilities are classified as current or noncurrent based on the timing of when the Company expects to service the warranty, or complete the lab services contract. At March 31, 2025, the Company recorded contract liabilities of $
Cost to Obtain and Fulfill a Contract
Under ASC 606, the Company is required to capitalize certain costs to obtain customer contracts and costs to fulfill customer contracts. These costs are required to be amortized to expense on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates, compared to previously being expensed as incurred. As a practical expedient, the Company recognizes any incremental costs to obtain a contract as an expense when incurred if the amortization period of the asset is
Stock-based compensation
The Company records stock-based compensation for awards granted to employees, non-employees, and to members of the Board of Directors of the Company (the “Board”) for their services on the Board based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period, which is generally
The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. The expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of company-specific historical and implied volatility, the Company bases its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded, in combination with the Company’s historical volatility. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the Company’s and the selected companies’ shares during the equivalent period of the calculated expected term of its stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding volatility of its own stock price becomes available. The risk-free interest rate is determined by reference to the U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of common stock; therefore, the expected dividend yield is assumed to be
For restricted stock units (“RSUs”) issued under the Company’s stock-based compensation plans, the fair value of each grant is calculated based on the Company’s stock price on the date of grant.
14
The Company has elected to account for forfeitures as they occur; any compensation cost previously recognized for an award that is forfeited because of a failure to satisfy a service or performance condition will be reversed in the period of the forfeiture.
Refer to Note 13 – Stock compensation plans for further details on the Company’s stock-based compensation plans.
Net loss per share attributable to common stockholders
Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average common shares outstanding during the period. For purposes of the diluted net loss per share calculations, stock options, and unvested restricted stock units, are considered to be potentially dilutive securities, but are excluded from the diluted net loss per share because their effect would be anti-dilutive and therefore basic and diluted net loss per share were the same for all periods presented.
Comprehensive loss
Components of comprehensive loss, including net loss, are reported in the financial statements in the period in which they are recognized. Other comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net loss and other comprehensive loss are reported net of any related tax effect to arrive at comprehensive loss. Comprehensive loss includes net loss as well as other changes in stockholders’ (deficit) equity that result from transactions and economic events other than those with stockholders which for the three months ended March 31, 2025 and 2024 consist of unrealized loss on marketable securities.
Marketable securities
Marketable securities represent holdings of available-for-sale marketable debt securities in accordance with the Company’s investment policy. Short-term marketable securities mature within one year from the balance sheet date while long-term marketable securities mature after one year. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive loss as a separate component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are reflected as a component of interest income. Interest on securities sold is determined based on the specific identification method and reflected as interest income. Any realized gains or losses on the sale of investment are reflected as realized (loss) gain on investments.
Recent accounting standards
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company is considered to be an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (Jobs Act). The Jobs Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company has elected to avail itself of this extended transition period and, as a result, the Company will not be required to adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
Recently issued but not yet adopted accounting standards
In December 2023, the FASB issued ASC Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update enhances income tax disclosure requirements by requiring public entities to provide additional information in its tax rate reconciliation and additional disclosures about income taxes paid. The update is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance and the amendments in this update
15
should be applied prospectively, but entities have the option to apply it retrospectively. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disaggregated disclosure of income statement expenses. ASU 2024-03 does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. ASU 2024-03 is effective for public business entities for annual periods beginning after December 15, 2026, with early adoption permitted. The Company is currently evaluating the impact of this standard on its disclosure of consolidated statement of operations.
(4) Significant risks and uncertainties including business and credit concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, marketable securities, and receivables. The Company’s cash equivalents are held by large, credit worthy financial institutions. Marketable securities consist of short-term investments. The Company has established guidelines relative to credit ratings, diversification and maturities that seek to maintain safety and liquidity. Deposits in these banks generally exceed federally insured limits. To date, the Company has not experienced any losses on its deposits of cash and cash equivalents.
The Company controls credit risk through credit approvals, credit limits, and monitoring procedures. The Company performs periodic credit evaluations of its customers and generally does not require collateral. Accounts receivable are recorded net of an allowance for credit losses. The allowance for credit losses is developed using historical collection experience, current and future economic and market conditions, and a review of the status of customers’ accounts receivable. The Company had an allowance for credit losses of $
For the three months ended March 31, 2025 and 2024,
16
(5) Fair value of financial instruments
The Company measures the following financial liabilities at fair value on a recurring basis. There were
The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of March 31, 2025 and December 31, 2024:
Quoted Prices | ||||||||||||
in Active | Significant | |||||||||||
Markets for | Other | Significant | ||||||||||
Balance at | Identical | Observable | Unobservable | |||||||||
March 31, | Assets | Inputs | Inputs | |||||||||
| 2025 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | | $ | — | ||||
U.S Treasury securities | | | | — | ||||||||
Total Assets | $ | | $ | | $ | | $ | — | ||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Contingent consideration – Short term portion | $ | | $ | | $ | | $ | | ||||
Contingent consideration – Long term portion | | | | | ||||||||
Total Liabilities | $ | | $ | | $ | | $ | |
Quoted Prices | ||||||||||||
in Active | Significant | |||||||||||
Markets for | Other | Significant | ||||||||||
Balance at | Identical | Observable | Unobservable | |||||||||
| December 31, |
| Assets |
| Inputs |
| Inputs | |||||
| 2024 |
| (Level 1) |
| (Level 2) |
| (Level 3) | |||||
Assets: | ||||||||||||
Cash equivalents | $ | | $ | | $ | | $ | — | ||||
U.S Treasury securities | | | | — | ||||||||
Commercial paper | | | | — | ||||||||
Total Assets | $ | | $ | | $ | | $ | — | ||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Contingent consideration – Long term portion | $ | | $ | | $ | | $ | | ||||
Total Liabilities | $ | | $ | | $ | | $ | |
The following is a summary of cash equivalents and marketable securities as of March 31, 2025 and December 31, 2024:
March 31, 2025 | ||||||||||||
Gross | Gross | |||||||||||
Unrealized | Unrealized | Estimated | ||||||||||
| Cost |
| Gains |
| Losses |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Marketable securities (due in one year or less): | ||||||||||||
U.S Treasury securities | | — | ( | | ||||||||
Total marketable securities due in one year or less | | — | ( | | ||||||||
Total cash equivalents and marketable securities | $ | | $ | — | $ | ( | $ | |
17
December 31, 2024 | ||||||||||||
Gross | Gross | |||||||||||
Unrealized | Unrealized | Estimated | ||||||||||
| Cost |
| Gains |
| Losses |
| Fair Value | |||||
Cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Marketable securities (due in one year or less): | ||||||||||||
U.S Treasury securities | | | — | | ||||||||
Commercial paper | | — | — | | ||||||||
Total marketable securities due in one year or less | | | — | | ||||||||
Total cash equivalents and marketable securities | $ | | $ | | $ | — | $ | |
The Company held two debt securities at March 31, 2025 classified as marketable securities with original maturity dates greater than three months that were in an unrealized loss position for less than twelve months. The fair market value of these securities was $
The Company had no material realized gains or losses on its available-for-sale securities for the three months ended March 31, 2025 and 2024.
The Company’s recurring fair value measurements using Level 3 inputs relate to the Company’s contingent consideration liability. In those circumstances where an acquisition involves a contingent consideration arrangement, the Company recognizes a liability equal to the fair value of the contingent payments the Company expects to make as of the acquisition date. The Company re-measures this liability each reporting period and records changes in the fair value through changes in fair value of contingent consideration on the Company’s consolidated statements of operations. Increases or decreases in the fair value of the contingent consideration liability can result from changes in discount rates, periods, timing and amount of projected revenue.
The recurring Level 3 fair value measurements of the Company’s contingent consideration liability include the following significant unobservable inputs:
Fair Value | Fair Value |
|
| ||||||
as of | as of | ||||||||
March 31, | December 31, | Valuation | Unobservable | ||||||
Contingent Consideration Liability |
| 2025 |
| 2024 | Technique |
| Inputs | ||
Revenue-based Payments | $ | |
| $ | | Discounted Cash Flow Analysis under the Income Approach |
| Revenue discount factor, discount rate |
18
(6) Property and equipment, net
Property and equipment consists of the following:
Estimated Useful | March 31, | December 31, | ||||||
| Life (Years) |
| 2025 |
| 2024 | |||
Furniture and fixtures |
| $ | | $ | | |||
Computers, laptop and peripherals |
|
| |
| | |||
Laboratory equipment |
|
| |
| | |||
Leasehold improvements |
| Shorter of the lease life or |
| |
| | ||
Total property and equipment |
|
|
| |
| | ||
Less: Accumulated depreciation |
|
|
| ( |
| ( | ||
Property and equipment, net |
|
| $ | | $ | |
There was
Depreciation expense relating to property and equipment charged to operations was $
Demo inventory consists of the following:
Estimated | March 31, | December 31, | ||||||
| Life (Years) |
| 2025 |
| 2024 | |||
Demo inventory – gross |
| $ | | $ | | |||
Less: Accumulated depreciation |
|
|
| ( |
| ( | ||
Demo inventory, net |
|
| $ | | $ | |
Depreciation expense relating to demo equipment charged to operations was $
(7) Allowance for credit losses
The Company is exposed to credit losses primarily through sales of products and services. The Company’s expected loss allowance methodology for accounts receivable is developed using historical collection experience, current and future economic and market conditions, and a review of the current status of customers’ trade accounts receivable. Due to the short-term nature of such receivables, the estimated accounts receivable that may not be collected is based on aging of the accounts receivable balances.
The Company evaluates contract terms and conditions, country, and political risk, and may require prepayment to mitigate risk of loss. Specific allowance amounts are established to record the appropriate provision for customers that have a higher probability of default. The Company monitors changes to the receivables balance on a timely basis, and balances are written off as they are determined to be uncollectable after all collection efforts have been exhausted.
As of March 31, 2025, the Company’s accounts receivable balance was $
19
March 31, 2025 that is deducted from the amortized cost basis of accounts receivable to present the net amount expected to be collected.
Balance as of December 31, 2024 | $ | | |
Change in provision | | ||
Balance as of March 31, 2025 | $ | |
The following table provides a roll-forward of the allowance for credit losses for the three months ended March 31, 2024 that is deducted from the amortized cost basis of accounts receivable to present the net amount expected to be collected.
Balance as of December 31, 2023 | $ | | |
Change in provision | | ||
Balance as of March 31, 2024 | $ | |
(8) Inventories, net
Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials, direct labor and manufacturing overhead, using the average cost method. The Company analyzes its inventory levels on each reporting date for excess and obsolete inventory. The Company’s analysis requires judgment and is based on factors including, but not limited to, recent historical activity, anticipated or forecasted demand for its products, and market conditions. The Company writes down any excess and obsolete inventories to their realizable value in the period in which the impairment is first identified. Shipping and handling costs incurred for inventory purchases are capitalized and recorded upon sale within the cost of goods sold in the consolidated statements of operations.
Inventories, net consisted of the following:
March 31, | December 31, | ||||||
| 2025 |
| 2024 | ||||
Raw materials |
| $ | | $ | | ||
Finished goods |
|
| |
| | ||
Total inventories, net |
| $ | | $ | |
(9) Intangible assets
Intangible assets as of March 31, 2025 are summarized as follows:
Accumulated | Useful Life | ||||||||
| Cost |
| Amortization |
| Net |
| (in years) | ||
Customer relationships | $ | | $ | ( | $ | |
| ||
Developed technology | |
| ( |
| |
| |||
Licenses | |
| ( |
| |
| |||
Trade names and trademarks | |
| ( |
| |
| |||
Capitalized software | |
| ( |
| |
| |||
Total intangible assets | $ | | $ | ( | $ | |
|
|
20
Intangible assets as of December 31, 2024 are summarized as follows:
Accumulated | Useful Life | ||||||||
| Cost |
| Amortization |
| Net |
| (in years) | ||
Customer relationships | $ | | $ | ( | $ | |
| ||
Developed technology | |
| ( |
| |
| |||
Licenses | |
| ( |
| |
| |||
Trade names and trademarks | |
| ( |
| |
| |||
Capitalized software | |
| ( |
| |
| |||
Total intangible assets | $ | | $ | ( | $ | |
|
|
Total amortization expense was $
As of March 31, 2025, the amortization expense related to identifiable intangible assets in future periods is expected to be as follows:
2025 remaining |
| $ | |
2026 |
| | |
2027 |
| | |
2028 |
| | |
2029 | | ||
Thereafter |
| | |
Total | $ | |
(10) Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following:
March 31, | December 31, | |||||
| 2025 |
| 2024 | |||
Payroll and compensation | $ | | $ | | ||
Current portion of contingent consideration |
| |
| | ||
Inventory purchases |
| |
| | ||
Customer deposits | | | ||||
Accrued interest | | | ||||
Accrued legal | | | ||||
Other accrued expenses |
| |
| | ||
Total accrued expenses and other current liabilities | $ | | $ | |
(11) Debt
Term Loan Agreements
In October 2020, the Company entered into the Midcap Trust Term Loan with Midcap Financial Trust, for a $
The Midcap Trust Term Loan initially provided for an interest only term for
21
make funds available in an amount determined by multiplying the amount being prepaid by (i) three percent (
On March 21, 2022, the Company entered into Amendment No. 1 to the Midcap Trust Term Loan, which amended certain provisions to permit certain additional debt and capital leases.
On June 1, 2022, the Company entered into Amendment No. 2 (“Amendment No. 2”) to the Midcap Trust Term Loan, which permitted the draw of a second tranche of $
On November 7, 2022, the Company entered into Amendment No. 3 (“Amendment No. 3”) to the Midcap Trust Term Loan, which permitted the draw of two additional tranches, each totaling $
In July 2024, the Company entered into Amendment No. 4 (“Amendment No. 4”) to the Midcap Trust Term Loan, which amended certain affirmative financial covenants.
In November 2024, the Company entered into Amendment No. 5 (“Amendment No. 5”) to the Midcap Trust Term Loan, effective as of September 30, 2024, which amended certain affirmative financial covenants. Amendment No. 5 also extended the interest only period from December 1, 2025 until March 1, 2026 (subject to further extension upon certain conditions), at which point the Company must repay the principal amounts in equal monthly installments until the maturity date of November 1, 2027. Finally, Amendment No. 5 increased the exit fee from
On May 12, 2025, the Company entered into Amendment No. 6 (“Amendment No. 6”), pursuant to which, among other things, Midcap Financial Trust, as agent, waived existing events of default as of March 31, 2025 and through the date of Amendment No. 6 and the parties amended certain affirmative financial covenants. Additionally, Amendment No. 6 includes certain additional restrictive covenants, including amending or modifying the Merger Agreement which is reasonably expected to be materially adverse to Midcap’s interest. Substantially all other term and conditions, and covenants of the Midcap Trust Term Loan remain unchanged.
The Company was not in compliance with certain covenants at March 31, 2025 under the Midcap Trust Term Loan. As of the date of this Quarterly Report on Form 10-Q, after giving effect to Amendment No. 6, the Company is in compliance with all covenants under the Midcap Trust Term Loan as of March 31, 2025 and through the date these consolidated financial statements were issued.
The interest rate was
22
Given that the Company does not expect to maintain compliance with certain financial covenants under the Midcap Trust Term Loan at July 31, 2025 in the event the Merger is not consummated, the Company has classified the Midcap Trust Loan as a current liability in the consolidated balance sheet as of March 31, 2025.
For the three months ended March 31, 2025 and 2024, the Company recorded $
Debt consists of the following:
March 31, | December 31, | |||||
| 2025 |
| 2024 | |||
Midcap Trust Term Loan |
| $ | |
| $ | |
Unamortized debt discount |
| ( |
| ( | ||
Accretion of final fee |
| |
| | ||
Total debt, net | | | ||||
Less amount included as short-term | ( | — | ||||
Long-term debt, net | $ | — | $ | |
(12) Stockholder’s (deficit) equity
The Company’s Amended and Restated Certificate of Incorporation authorizes it to issue
On November 7, 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $
Issuance costs incurred related to the Equity Distribution Agreement are classified as current assets on the consolidated balance sheet at March 31, 2025 and December 31, 2024.
23
(13) Stock compensation plans
2021 Equity Incentive Plan
On March 24, 2021, the Board, and on April 8, 2021, the Company’s stockholders, approved and adopted the 2021 Equity Incentive Award Plan (the “2021 Plan”). The 2021 Plan became effective immediately prior to the closing of the IPO. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. A total of
2015 Equity Incentive Plan
The 2015 Plan was established for granting stock incentive awards to directors, officers, employees and consultants to the Company. The 2015 Plan provided for the grant of incentive and non-qualified stock options, stock appreciation rights, restricted stock and restricted stock units as determined by the Board. Under the 2015 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the Board, expired no later than
Stock Options
During the three months ended March 31, 2025,
During the three months ended March 31, 2024, the Company granted options to purchase
Three months ended | |||
March 31, | |||
| 2024 | ||
Weighted-average risk-free interest rate | | % | |
Expected dividend yield | — | % | |
Expected volatility | | % | |
Expected term |
|
Restricted Stock Units
During the three months ended March 31, 2025 and 2024, the Company granted RSUs with an aggregate fair value of $
24
The fair value of each grant is calculated based on the Company’s stock price on the date of grant. During the three months ended March 31, 2025, the Company granted
Stock-Based Compensation
Stock-based compensation related to the Company’s stock-based awards was recorded as an expense and allocated as follows:
Three months ended | ||||||
March 31, | ||||||
| 2025 |
| 2024 | |||
Cost of goods sold | $ | | $ | | ||
Selling, general and administrative |
| |
| | ||
Research and development |
| |
| | ||
Total stock-based compensation | $ | | $ | |
On November 19, 2024, the Board approved a stock option repricing wherein the exercise price of each Eligible Option was reduced to the price of the Company’s common stock as of the market close on November 19, 2024, or $
As of March 31, 2025, there was $
As of March 31, 2025, there was $
(14) Employee stock purchase plan
On March 24, 2021, the Board and on April 8, 2021, the Company’s stockholders approved and adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP became effective in connection with the closing of the Company’s IPO. The ESPP permits participants to purchase common stock through payroll deductions of up to
(15) Income taxes
During the three months ended March 31, 2025 and 2024, the Company recorded a tax provision of $
25
allowance against its U.S. deferred tax assets as the Company believes it is more likely than not the deferred tax assets will not be realized.
(16) Commitments and contingencies
License Agreements
In September 2018, in connection with the acquisition of the QPS division of PKI (subsequently known as Revvity), the Company entered into a License Agreement with PKI, pursuant to which PKI granted the Company an exclusive, nontransferable, sublicensable license under certain patent rights to make, use, import and commercialize QPS products and services. The Company is required to pay royalties on net sales of products and services that are covered by patent rights under the agreement at a rate ranging from
Changes in the fair value of the Company’s long-term portion of the contingent consideration liability during the three months ended March 31, 2025 and 2024 were as follows:
Balance as of December 31, 2024 |
| $ | |
Reclassification of FY 2025 payment to accrued expenses |
| ( | |
| | ||
Balance as of March 31, 2025 | $ | |
Balance as of December 31, 2023 |
| $ | |
Reclassification of FY 2024 payment to accrued expenses |
| ( | |
| | ||
Balance as of March 31, 2024 | $ | |
(17) Net loss per share attributable to common stockholders
Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards. Awards granted with performance conditions are excluded from the shares used to compute diluted earnings per share until the performance conditions associated with the awards are met.
The following table sets forth the computation of basic and diluted earnings per common share:
Three months ended | |||||||
March 31, | |||||||
| 2025 |
| 2024 |
| |||
Net loss | $ | ( | $ | ( | |||
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted |
| |
| | |||
Basic and diluted net loss per common share outstanding | $ | ( | $ | ( |
The Company’s potential dilutive securities, which include stock options, and unvested restricted stock units, have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following potential common shares, presented based on amounts outstanding at
26
each period end, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
March 31, | ||||
| 2025 |
| 2024 | |
Outstanding stock options |
| |
| |
Unvested restricted stock units | | | ||
Total |
| |
| |
(18) Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker (the “CODM”) in deciding how to allocate resources and assess performance. The Company’s CODM, the Company’s chief executive officer, reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The CODM views the Company’s operations and manages its business as a single operating segment. Accordingly, the Company has a
reportable segment structure. The measure of segment assets is reported on the balance sheet as total assets. The Company’s principal operations and decision-making functions are located in the United States.In accordance with ASC 2023-07, Segment Reporting (Topic 280): Improvement to Reportable Segment Disclosures, the following table presents the segment revenue and significant expense categories included within the Company’s segment’s measure of loss for the three months ended March 31, 2025 and 2024:
Three months ended | ||||||
March 31, | ||||||
($ in thousands) |
| 2025 |
| 2024 | ||
Revenue |
| |
| | ||
Less: | ||||||
Cost of goods sold, excluding depreciation, amortization, and stock-based compensation |
| |
| | ||
Operating expenses - compensation and benefits |
| |
| | ||
Operating expenses - outside services | | | ||||
Other segment items(a) |
| |
| | ||
Depreciation and right-of-use amortization | | | ||||
Amortization of intangibles | | | ||||
Stock-based compensation | | | ||||
Change in fair value of contingent consideration |
| |
| | ||
Impairment |
| — |
| | ||
Interest expense |
| |
| | ||
Interest income | ( | ( | ||||
Other expense, net |
| |
| | ||
Provision for income taxes |
| |
| | ||
Net loss | $ | ( | $ | ( |
(a) | Other segment items included in net loss includes insurance, rent and utilities, repairs & maintenance, IT, lab supplies, travel & entertainment, allowance for credit losses, and other overhead expenses. |
27
The following table provides the Company’s revenues by geographical market based on the location where the services were provided or to which product was shipped:
Three months ended | |||||||
March 31, | |||||||
| 2025 |
| 2024 |
| |||
North America | $ | | $ | | |||
APAC |
| |
| | |||
EMEA |
| |
| | |||
Total Revenue | $ | | $ | |
Three months ended |
| |||||
March 31, |
| |||||
| 2025 |
| 2024 |
| ||
North America |
| | % | | % | |
APAC |
| | % | | % | |
EMEA |
| | % | | % | |
Total Revenue |
| | % | | % |
North America includes the United States and related territories, as well as Canada. APAC also includes Australia. For the three months ended March 30, 2025 and 2024, the Company had
As of March 31, 2025 and December 31, 2024, substantially all of the Company’s long-lived assets are located in the United States.
(19) Related party transactions
Argonaut Manufacturing Services Inc. (“AMS”) is a portfolio company of Telegraph Hill Partners, which holds greater than
One of the Company’s officers is a member of the board of directors of a software-as-a-service provider, who provides software development services to the Company, which are utilized for research purposes. During the three months ended March 31, 2025 and 2024, the Company incurred research and development expenses of $
(20) Leases
There were
In the first quarter of 2024, the Company ceased use of its leased facility in Menlo Park, California with the intention to either sublease or exit the vacant space to recover a portion of the total lease costs. The Company’s cease use of its leased facilities required an impairment assessment and the related right-of-use (“ROU”) assets and property and equipment became their own asset group. The impairment analysis evaluated the present value of net cash flows under the original lease and the estimated cash flows under estimated subleases to identify any potential impairment amount. The impairment assessment considered all industry and economic factors such as rental rates, interest rates, and recent real estate activities to estimate the net cash flows analysis and impairment amount.
28
The above assessments resulted in the Company recording an impairment charge of $
In June 2024, the Company signed a
The Company is a lessee under operating leases of offices, warehouse space, laboratory space, and auto leases, and financing leases of computer equipment and staining equipment.
Some leases include an option to renew, with renewal terms that can extend the lease term by five years. The exercise of lease renewal options is at the Company’s sole discretion. None of these options to renew are recognized as part of the Company’s ROU asset or lease liability as of March 31, 2025, as renewal was determined to not be reasonably assured.
The table below summarizes the Company’s lease costs for the three months ended March 31, 2025 and 2024:
Three months ended March 31, | |||||||||
Lease Costs |
| Classification |
| 2025 |
| 2024 |
| ||
Finance lease cost: | |||||||||
Amortization of right-of-use assets | Cost of service and other revenue | $ | $ | ||||||
Amortization of right-of-use assets | Selling, general and administrative | ||||||||
Amortization of right-of-use assets | Research and development | ||||||||
Interest on lease liabilities | Interest expense, net | ||||||||
Operating lease cost: | |||||||||
Sublease income | Selling, general and administrative | ( | — | ||||||
Rent expense | Cost of product revenue | | |||||||
Rent expense | Selling, general and administrative | | | ||||||
Total lease cost | $ | | $ |
As of March 31, 2025, future minimum commitments under ASC 842 under the Company’s operating leases were as follows:
Maturity of operating lease liabilities |
| As of March 31, 2025 | |
2025 remaining | $ | ||
2026 | |||
2027 | |||
2028 | |||
2029 | |||
Thereafter | |||
Total lease payments | $ | | |
Less: discount to lease payments | ( | ||
Total operating lease liabilities | $ | |
29
As of March 31, 2025, future minimum commitments under ASC 842 under the Company’s financing leases were as follows:
Maturity of financing lease liabilities |
| As of March 31, 2025 | |
2025 remaining | $ | | |
2026 | | ||
2027 | | ||
2028 | | ||
Total lease payments | $ | | |
Less: discount to lease payments | ( | ||
Total financing lease liabilities | $ | |
The table below summarizes the weighted-average remaining lease term (in years), the weighted-average incremental borrowing rate (in percentages), as well as supplemental cash flow information related to leases for the three months ended March 31, 2025 and 2024:
Three months ended March 31, | ||||||||
Lease Term, Discount Rates, and Other |
| 2025 |
| 2024 | ||||
Weighted average remaining lease term | ||||||||
Operating leases | years | years | ||||||
Financing leases | years | years | ||||||
Weighted average incremental borrowing rate | ||||||||
Operating leases | % | % | ||||||
Financing leases | | % | | % | ||||
Cash payments of amounts included in lease liabilities | ||||||||
Operating cash flows from operating leases | $ | | $ | | ||||
Operating cash flows from finance leases | | | ||||||
Financing cash flows from finance leases | | |
(21) Reduction in force
In January of 2024, the Company initiated a workforce reduction in connection with certain operating expense cost savings initiatives implemented by the Company, including the consolidation of its facilities and the exit of its Menlo Park, California leased facility as discussed in Note 20 – Leases. This workforce reduction was substantially completed by the end of the first quarter of 2024.
During the three months ended March 31, 2024, the Company recorded $
In July 2024, the Company initiated a workforce reduction in connection with certain operating expense cost savings initiatives. This workforce reduction was substantially completed by the end of the third quarter of 2024.
During the three months ended September 30, 2024, the Company recorded $
(22) Subsequent events
The Company has evaluated subsequent events from the consolidated balance sheet date through May 12, 2025, which is the date the consolidated financial statements were issued.
30
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended December 31, 2024 included in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2025. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those described in our Annual Report on Form 10-K for the year ended December 31, 2024, as referred to in the section titled “Risk Factors” under Part II, Item 1A below. Please also see the section titled “Special note regarding forward looking statements.”
Overview
We are an innovative life sciences technology company delivering spatial biology solutions focused on transforming discovery, clinical research and diagnostics. Our mission is to bring context to the world of biology and human health through the power of spatial phenotyping. Spatial phenotyping refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Through our PhenoCycler and PhenoImager platforms, reagents, software and services, we offer end-to-end solutions to perform tissue analysis and spatial phenotyping across the full continuum from discovery through translational and clinical research and diagnostics.
Our spatial biology solutions measure cells and proteins by providing biomarker data in its spatial context while preserving tissue integrity. Biomarkers are objective measures that capture what is happening in a cell or tissue at a given moment. Current genomic and proteomic methods, such as next-generation sequencing (“NGS”), single-cell analysis, flow cytometry and mass spectrometry, are providing meaningful data but require the destruction of the tissue sample for analysis. While valuable and broadly adopted, these approaches allow scientists to analyze the biomarkers and cells that comprise the tissue but do not provide the fundamental information about tissue structure, cellular interactions and the localized measurements of key biomarkers. Furthermore, current non-destructive tissue analysis and histological methods provide some limited spatial information, but they only measure a minimal number of biomarkers at a time and require expert pathologist interpretation. Our platforms address these limitations by providing end-to-end solutions that enable researchers to quantitatively interrogate a large number of biomarkers and cell types across a tissue section at single-cell resolution. The result is a detailed and computable map of the tissue sample that thoroughly captures the underlying tissue dynamics and interactions between key cell types and biomarkers, a process now referred to as spatial phenotyping. We believe that we are the only business with the breadth of platform capabilities that enable researchers to do a deep exploratory and discovery study, and then further advance and scale their research through the translational and clinical phases, leading to a better understanding of human biology, disease progression and response to therapy. We also believe that we are the only spatial biology business that is capable of delivering a menu of clinical in vitro diagnostics tests on our platform for routine diagnostic testing.
We offer complete end-to-end solutions for spatial phenotyping, designed to serve the unique needs of our customers in the discovery, translational and clinical markets. The PhenoCycler is an ultra-high parameter and cost-effective platform ideally suited for discovery high-plex research. The PhenoImager platforms, which includes the Fusion instrument and HT instrument, provide high-throughput scalable solutions with the automation and robustness needed for translational and clinical applications. Furthermore, the PhenoCycler and the PhenoImager Fusion can be integrated into a combined system, the PhenoCycler-Fusion, to enable spatial discovery at scale by providing significant improvements in the speed of the workflow. Our portfolio of products offer seamless and integrated workflow solutions for our customers, including important benefits such as flexible sample types, automated sample processing, scalability, comprehensive data analysis and software solutions and dedicated field and applications support. With these platforms,
31
our customers are performing spatial phenotyping to further advance their understanding of diseases such as cancer, neurological and autoimmune disorders, and many other therapeutic areas.
For the three months ended March 31, 2025 and 2024, revenue from North America accounted for approximately 61% and 55% of our revenue, respectively.
We generally outsource the manufacturing of our instruments and certain of our reagents. Design work and prototyping are performed in-house before pilot manufacturing and production are outsourced to third-party contract manufacturers. We use one contract manufacturer to produce our PhenoImager and PhenoCycler instruments, and several suppliers to produce certain of our reagent kits and components. Additionally, we have made investments in our infrastructure to support strategic in-house manufacturing as it relates to our critical and high-complexity proprietary reagents. The contract manufacturers of our systems and reagent kits are located in the United States and Asia. Certain of our suppliers of components and materials are single source suppliers.
As of the date of this Quarterly Report on Form 10-Q, we have financed our operations primarily from the issuance and sale of our equity securities, borrowings under our long-term debt agreement, and revenue from our commercial operations. We have incurred net losses in each period since our inception in 2015. Our net losses were $15.7 million and $23.5 million for the three months ended March 31, 2025 and 2024, respectively. We expect to continue to incur operating losses for the foreseeable future. In the event that the transaction contemplated under the Merger Agreement we have entered into with Quanterix is not consummated, based on our current operating plan, we do not expect to maintain compliance with certain financial covenants at July 31, 2025 under the Midcap Trust Term Loan. In such event, we would intend to seek a waiver, refinance the outstanding borrowings or otherwise mitigate these concerns with Midcap Financial Trust or another lender. There can be no assurance that a waiver will be granted or that we will be able to refinance the amounts outstanding, and in such an event, the lender may exercise any and all of its rights and remedies provided for under the Midcap Trust Term Loan. As a result of these uncertainties, there is substantial doubt about our ability to continue as a going concern for the next twelve months. However, we plan to continue to grow our business while improving results of operations in an effort to achieve cash flow positivity, as we:
● | attract, hire and retain qualified personnel, including in connection with our investments in our infrastructure to support in-house manufacturing; |
● | market and sell new and existing solutions and services; |
● | invest in processes and infrastructure to scale our business; |
● | support research and development to introduce new solutions; |
● | expand, protect and defend our intellectual property; and |
● | acquire complementary businesses or technologies to support the growth of our business. |
Key factors affecting our results of operations and future performance
There are a number of factors that have impacted, and we believe will continue to impact, our business, results of operations and growth. Our ability to successfully address these factors is subject to various risks and uncertainties, including those described under the heading “Risk Factors.”
Our ability to expand our installed base
We are focused on increasing sales of our PhenoCycler and PhenoImager platforms (Fusion and HT) to new and existing customers. Our financial performance has historically been driven by, and will continue to be impacted by, the volume of instrument sales. Additionally, instrument sales are a leading indicator of future recurring revenue from consumables and services. Our operating results and growth prospects will be dependent in part on our ability to increase
32
our instrument installed base as we further penetrate existing markets and expand into, or offer new features and solutions that appeal to, new markets.
We believe our market is still evolving and relatively underpenetrated. As spatial biology is further validated through rapid acceleration of peer-reviewed publications and growing adoption by the life sciences research market, we believe we have an opportunity to significantly increase our installed base. We regularly solicit feedback from our customers in order to enhance our solutions and their applications for life sciences research, which we believe will drive increased adoption of our platforms as they better serve our customers’ needs.
Our ability to drive incremental pull through
We believe that expansion of our installed base to new and existing customers will drive an increase in our recurring reagent and instrument service revenue. In addition, as our research and development team identifies and launches new applications and biomarker targets, we expect to increase incremental pull through on our existing and new instrument installed base. Recurring revenue was 59% and 54% of total revenue for the three months ended March 31, 2025 and 2024, respectively. Our recurring revenue as a percentage of total product and service revenue will vary based upon new device placements in the period. As our installed base expands, we expect recurring revenue on an absolute basis to increase and become an increasingly important contributor to our revenue.
Our ability to improve revenue mix and gross margin
Our revenue is primarily derived from sales of our platforms, consumables, software, and services. Our revenue mix will fluctuate from period-to-period, particularly revenue generated from instrument sales. As our installed base grows, we expect consumables and instrument service revenue to constitute a larger percentage of total revenue.
Our margins are higher for those instruments and consumables that we sell directly to customers compared to those sold through distributors.
Future instrument and consumable selling prices and gross margins may fluctuate due to a variety of factors, including the introduction by others of competing products and solutions. We aim to mitigate downward pressure on our average selling prices by increasing the value proposition offered by our instruments and consumables, primarily by expanding the applications for our devices, optimizing the performance of our products, introducing feature enhancements and increasing the quantity and quality of data that can be obtained using our consumables.
Key Business Metrics
We regularly review the number of instrument placements and cumulative instrument placement as key metrics to evaluate our business, measure our performance, identify trends affecting our business, develop financial projections, and make strategic decisions. We believe that these metrics are representative of our current business; however, we anticipate these will change or may be substituted for additional or different metrics as our business grows.
During the three months ended March 31, 2025 and 2024, our instrument placements were as follows:
Three months ended | |||||
March 31, | |||||
| 2025 |
| 2024 |
| |
Instrument Placements: |
| 29 |
| 30 |
Our instruments are sold globally to leading biopharma companies and top research institutions and medical centers. Our quarterly instrument placements fluctuate from period-to-period due to the type and size of our customers and their procurement and budgeting cycles. We expect continued fluctuations in our quarterly period-to-period number of instrument placements.
33
We believe our instrument placements is an important metric to measure our business because the number of new placements is driven by our ability to secure new customers and to increase adoption of our PhenoCycler and PhenoImager platforms and because it provides insights into anticipated recurring revenue for consumables and instrument services.
Components of results of operations
Revenue
Product Revenue
We generate product revenue from the sale of our instruments, consumables and software products. Instrument sales accounted for 42% and 40% of product revenue for the three months ended March 31, 2025 and 2024, respectively. Consumables revenue accounted for 58% of our product revenue for each of the three months ended March 31, 2025 and 2024.
Our current instrument offerings include our PhenoCycler and PhenoImager platforms. Our sales process with customers is often long and involves multiple levels of approvals. As a result, the revenue for our platforms can vary significantly from period-to-period and has been, and may continue to be, concentrated in a small number of customers in any given period.
We sell our instruments directly to customers and through distributors. Each of our instrument sales drives various streams of recurring revenue comprised of consumable product sales and instrument services.
Service and Other Revenue
We primarily generate service and other revenue from instrument service, which generally consists of sales of extended service contracts, in addition to installation and training, as well as from our laboratory services operations, where we provide sample testing services to customers utilizing our in-house lab operation, and revenue generated from companion diagnostic development.
We offer our customers extended warranty and service plans for our platforms. Our extended warranty and service plans are offered for periods beyond the standard one-year warranty that all customers receive. These extended warranty and service plans generally have fixed fees and terms ranging from one to four additional years. We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us.
We record shipping and handling billed to customers as service and other revenue and the related costs in cost of service and other revenue in the consolidated statement of operations.
We sell our products globally. We sell directly to end customers in North America and we sell through third party distributors and dealers in the APAC region. We sell both directly and through third party distributors in EMEA.
Cost of Goods Sold, Gross Profit and Gross Margin
Product cost of revenue primarily consists of costs for finished goods (both instruments and reagents) produced by our contract manufacturers or in-house, and associated freight, shipping and handling costs for products shipped to customers, salaries and other personnel costs, and other direct costs related to those sales recognized as product revenue in the period. Cost of goods sold for services and other revenue primarily consists of salaries and other personnel costs, travel related to services provided, costs of servicing equipment at customer sites, and all personnel and related costs for our laboratory services operation.
We expect that our cost of goods sold will increase or decrease to the extent that our revenue increases and decreases and depending on the mix of revenue in any specific period.
34
Gross profit is calculated as revenue less cost of goods sold. Gross margin is gross profit expressed as a percentage of revenue. Our gross profit in future periods will depend on a variety of factors, including market conditions that may impact our pricing, sales mix among instruments, sales mix changes among consumables, excess and obsolete inventories, costs we pay our contract manufacturers for their services, our cost structure for lab service operations relative to volume, product warranty obligations, and inflationary cost pressures. Our gross profit in future periods will also vary based upon our channel mix and may decrease based upon our distribution channels.
Gross profit was $9.9 million compared to $8.4 million for the three months ended March 31, 2025 and 2024, respectively.
Operating expenses
Research and development. Research and development costs primarily consist of salaries, benefits, engineering/design costs, laboratory supplies, materials expenses for employees and third parties engaged in research and product development, and depreciation of property and equipment and amortization of intangibles. We expense all research and development costs in the period in which they are incurred.
We plan to continue to invest in our research and development efforts to enhance existing products and develop new products. We expect these expenses to vary from period to period as a percentage of revenue.
Selling, general and administrative. Our selling, general and administrative expenses primarily consist of salaries and benefits for employees in our executive, accounting and finance, sales and marketing, operations, legal and human resource functions, professional services fees, such as consulting, audit, tax and legal fees, legal expenses related to intellectual property, general corporate costs, commercial sales functions, marketing, travel expenses, facilities, and IT, as well as depreciation of property and equipment and amortization of intangibles. We expect these expenses to vary from period to period as a percentage of revenue.
Change in fair value of contingent consideration. On September 28, 2018, we acquired substantially all the assets of the QPS division of PKI (subsequently known as Revvity). As part of the acquisition, on September 28, 2018, we entered into a License Agreement with PKI. Under the terms of the License Agreement, we agreed to pay PKI certain royalties as a percentage of future net sales of products and services that are covered by patent rights under the agreement, in exchange for a perpetual license of the right to produce and sell QPS products. As of the acquisition date, we accounted for the future potential royalty payments as contingent consideration. This contingent consideration is subject to remeasurement.
Impairment. Impairment expense primarily consists of charges recorded as a result of exiting the Menlo Park, California facilities. As a result of exiting the facilities, we performed an impairment assessment of our long-lived assets, including operating lease right-of-use assets and property and equipment. A portion of our operating lease right-of-use assets (including related property and equipment) were determined to be impaired as their carrying values exceeded their fair values, and corresponding impairment charges were recorded in the three months ended March 31, 2024.
Restructuring. Restructuring expense primarily consists of charges recorded in connection with our workforce reductions executed in January of 2024.
Other income (expense)
Interest expense. Interest expense consists primarily of interest related to borrowings under our debt obligations.
Interest income. Interest income consists of interest earned on cash, cash equivalents, and marketable securities, and the accretion of discounts from the purchase of marketable securities.
Other expense, net. Other expense, net consists primarily of franchise tax and foreign currency exchange gains and losses.
35
Provision for income taxes
Our provision for income taxes consists primarily of foreign taxes and minimal state taxes in the United States. As we expand the scale and scope of our international business activities, any changes in the United States and foreign taxation of such activities may increase our overall provision for income taxes in the future.
Results of operations
The results of operations presented below should be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in the Quarterly Report on Form 10-Q. The following tables set forth our results of operations for the periods presented:
Three months ended | |||||||
March 31, | |||||||
($ in thousands) |
| 2025 |
| 2024 |
| ||
Product revenue | $ | 12,032 | $ | 12,140 | |||
Service and other revenue |
| 4,607 |
| 6,210 | |||
Total revenue |
| 16,639 |
| 18,350 | |||
Cost of goods sold: |
|
|
|
| |||
Cost of product revenue | 4,491 | 6,723 | |||||
Cost of service and other revenue |
| 2,277 |
| 3,248 | |||
Total cost of goods sold |
| 6,768 |
| 9,971 | |||
Gross profit |
| 9,871 |
| 8,379 | |||
Operating expenses: |
|
|
|
| |||
Selling, general and administrative |
| 17,580 |
| 19,863 | |||
Research and development |
| 5,557 |
| 5,554 | |||
Change in fair value of contingent consideration |
| 146 |
| 179 | |||
Impairment |
| — |
| 2,971 | |||
Restructuring | — | 1,397 | |||||
Total operating expenses |
| 23,283 |
| 29,964 | |||
Loss from operations |
| (13,412) |
| (21,585) | |||
Other income (expense): |
|
|
|
| |||
Interest expense |
| (2,492) |
| (2,612) | |||
Interest income | 313 | 937 | |||||
Other expense, net |
| (13) |
| (161) | |||
Loss before provision for income taxes |
| (15,604) |
| (23,421) | |||
Provision for income taxes |
| (48) |
| (63) | |||
Net loss | $ | (15,652) | $ | (23,484) |
Comparison of the three months ended March 31, 2025 and 2024
Revenue
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Product revenue | $ | 12,032 | $ | 12,140 |
| $ | (108) |
| (1) | % | ||
Service and other revenue |
| 4,607 |
| 6,210 |
|
| (1,603) |
| (26) | % | ||
Total revenue | $ | 16,639 | $ | 18,350 |
| $ | (1,711) |
| (9) | % |
Product revenue decreased by $0.1 million, or 1%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily driven by a $0.2 million decrease in instrument revenue resulting from 29 new system placements during the three months ended March 31, 2025, compared to 30 new system placements for the three months ended March 31, 2024, offset by a $0.1 million increase in consumable revenue
36
resulting from a larger installed base of 1,359 systems as of March 31, 2025, as compared to 1,213 systems as of March 31, 2024.
Service and other revenue decreased by $1.6 million, or 26%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily due to a decrease relating to lab services revenue, decreases in revenue generated from companion diagnostic development, and other immaterial changes.
Cost of Goods Sold, Gross Profit and Gross Margin
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Cost of product revenue | $ | 4,491 | $ | 6,723 | $ | (2,232) |
| (33) | % | |||
Cost of service and other revenue |
| 2,277 |
| 3,248 |
| (971) |
| (30) | % | |||
Total cost of goods sold | $ | 6,768 | $ | 9,971 | $ | (3,203) |
| (32) | % | |||
Gross profit | $ | 9,871 | $ | 8,379 | $ | 1,492 |
| 18 | % | |||
Gross margin |
| 59 | % |
| 46 | % |
|
|
|
|
Cost of product revenue decreased by $2.2 million, or 33%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease in cost of product revenue was primarily due to a $2.0 million charge recorded in the first quarter of 2024 related to obsolete inventory associated with the Mantra 2 Quantitative Pathology Workstation and the Vectra 3 Automated Quantitative Pathology Imaging System (collectively, the “Discontinued Products”), a legacy product line which was discontinued in the first quarter of 2024 and decrease in costs associated with decreased instrument sales, offset by costs associated with increased reagents sales. Cost of service and other revenue decreased by $1.0 million, or 30%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease in cost of service and other revenue was primarily driven by a decrease in personnel-related expenses due to the workforce reductions that we executed in January and July of 2024.
Gross profit decreased by $1.5 million, or 18%, and gross margin increased by 13% for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The decrease in gross profit was primarily due to the charge recorded in the first quarter of 2024 related to the Discontinued Products, as well as a decrease in instrument sales. The increase in gross margin was primarily due to the charge resulting from the Discontinued Products during the three months ended March 31, 2024.
Operating Expenses
Selling, General and Administrative
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Selling, general and administrative | $ | 17,580 | $ | 19,863 | $ | (2,283) |
| (11) | % |
Selling, general and administrative expense decreased by $2.3 million, or 11%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily due to a $3.4 million decrease in personnel-related expenses, primarily due to the workforce reductions in January and July of 2024, a $0.5 million decrease in rent, net of sublease income, due to exiting our Menlo Park facility in the first quarter of 2024, a $0.3 million decrease in charges to our allowance for credit losses, and a $0.3 million decrease in recruiting, training, conferences, and travel and expenses, offset by a $2.6 million increase in professional fees in connection with the Merger.
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Research and development
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Research and development | $ | 5,557 | $ | 5,554 | $ | 3 |
| 0 | % |
Research and development expense increased by $3.0 thousand, or 0%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The increase was primarily due to a $0.9 million increase in consulting, engineering, and lab supply consumption, partially offset by a $0.8 million decrease in personnel-related expenses, primarily due to the workforce reductions in January and July of 2024, and other immaterial changes.
Change in fair value of contingent consideration
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Change in fair value of contingent consideration | $ | 146 | $ | 179 | $ | (33) |
| (18) | % |
Change in fair value of contingent consideration was a $0.1 million loss for the three months ended March 31, 2025, compared to a $0.2 million loss for the three months ended March 31, 2024. The change in fair value of $33.0 thousand, or 18%, was due to current period remeasurement.
Impairment
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Impairment | $ | — | $ | 2,971 | $ | (2,971) |
| (100) | % |
Impairment decreased by $3.0 million, or 100% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to impairment charges to our right-of-use assets and property and equipment associated with exiting our Menlo Park, California facilities that were recorded in the first quarter of 2024.
Restructuring
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Restructuring | $ | — | $ | 1,397 | $ | (1,397) |
| (100) | % |
Restructuring decreased by $1.4 million, or 100% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to the workforce reductions that we executed in January of 2024.
Interest expense
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Interest expense | $ | 2,492 | $ | 2,612 | $ | (120) |
| (5) | % |
Interest expense decreased by $0.1 million, or 5% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was due to a decrease in interest rates.
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Interest income
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Interest income | $ | 313 | $ | 937 | $ | (624) |
| (67) | % |
Interest income decreased by $0.6 million, or 67% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due to decreased levels of cash, cash equivalents, and marketable securities as of March 31, 2025 as compared to March 31, 2024.
Other expense, net
Three months ended |
| |||||||||||
March 31, | Change |
| ||||||||||
($ in thousands, except percentages) |
| 2025 |
| 2024 |
| Amount |
| % | ||||
Other expense, net | $ | 13 | $ | 161 | $ | (148) |
| (92) | % |
Other expense, net decreased by $0.1 million, or 92%, for the three months ended March 31, 2025, compared to the three months ended March 31, 2025.
Liquidity and Capital Resources
As of March 31, 2025, we had approximately $27.5 million in cash, cash equivalents, and marketable securities.
Since our inception, we have experienced losses and negative cash flows from operations, and we incurred a consolidated net loss of $15.7 million for the three months ended March 31, 2025 and had an accumulated deficit of $301.1 million as of March 31, 2025. We expect to continue to incur operating losses in the foreseeable future. However, we plan to focus on improving results of operations in an effort to achieve cash flow positivity.
We have historically financed our operations primarily from the issuance and sale of our equity securities, borrowings under our long-term debt agreement, and revenue from our commercial operations. We may in the future sell shares of our common stock, including pursuant to the Equity Distribution Agreement, to help fund our operations. However, there can be no assurance that additional financings will be available to us or that we will become profitable.
If the transaction contemplated under our Merger Agreement with Quanterix is not consummated, based on our current operating plan, we do not expect to maintain compliance with certain financial covenants at July 31, 2025 under the Midcap Trust Term Loan. In such event, we would intend to seek a waiver, refinance the outstanding borrowings or otherwise mitigate these concerns with Midcap Financial Trust or another lender. There can be no assurance that a waiver will be granted or that we will be able to refinance the amounts outstanding, and in such an event, the lender may exercise any and all of its rights and remedies provided for under the Midcap Trust Term Loan. As a result of these uncertainties, there is substantial doubt about our ability to continue as a going concern for the next twelve months following the date that these consolidated financial statements are issued.
Our future capital requirements will depend on many factors, including, but not limited to our ability to successfully commercialize and launch products, and to achieve a level of sales adequate to support our cost structure. If we are unable to execute on our business plan and adequately fund operations, or if the business plan requires a level of spending in excess of cash resources, we will have to seek additional equity or debt financing. If additional financings are required from outside sources, we may not be able to raise capital on terms acceptable to us or at all. If we are unable to raise additional capital when desired, our business, financial condition, results of operations and prospects could be materially adversely affected.
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Sources of Liquidity
Since our inception, we have financed our operations primarily from the issuance and sale of our equity securities, borrowings under long-term debt agreements, and revenue from our commercial operations. In April 2021, we raised $138.6 million in net proceeds through the sale of common stock from our IPO, after deducting the underwriter discounts and commissions and offering expenses of $12.8 million. In June 2023, we completed a follow-on public offering of our common stock pursuant to which we raised approximately $47.8 million in net proceeds, after deducting the underwriting discounts and commissions and offering expenses.
Midcap Trust Term Loan
In October 2020, we entered into the Midcap Trust Term Loan for a $37.5 million credit facility, consisting of a senior, secured term loan. We received $32.5 million in aggregate proceeds as a result of the debt financing. On March 21, 2022, we entered into Amendment No. 1 to the Midcap Trust Term Loan, which amended certain provisions to permit certain additional debt and capital leases.
On June 1, 2022, we entered into Amendment No. 2, which permitted the draw of a second and third tranche of $10.0 million each, which were drawn on June 1, 2022, and September 30, 2022, respectively. Amendment No. 2 also delayed the amortization start dates for the outstanding loan amounts from November 1, 2023 until April 1, 2025, at which point we would be required to repay the principal amounts in seven equal monthly installments until the maturity date. Finally, Amendment No. 2 amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 1.61448%) plus 6.35%.
On November 7, 2022, we entered into Amendment No. 3 to the Midcap Trust Term Loan, which permitted the draw of two additional tranches, each totaling $11,250, which were drawn on November 7, 2022, and December 22, 2023, respectively. Amendment No. 3 also delayed the amortization start dates for the outstanding loan amounts from April 1, 2025 until December 1, 2025 (subject to further extension upon certain conditions), at which point we would be required to repay the principal amounts in equal monthly installments until the new maturity date of November 1, 2027. In addition, Amendment No. 3 amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 2.50%) plus 6.80%, and reset the call protection to begin as of November 7, 2025. Finally, Amendment No. 3 provided for a commitment fee of $74 that was paid on November 7, 2022 on the new tranche amounts and an exit fee of 4.75%. Substantially all other terms and conditions, and covenants of the credit agreement remained unchanged.
In July 2024, we entered into Amendment No. 4 to the Midcap Trust Term Loan, which amended certain affirmative financial covenants.
In November 2024, we entered into Amendment No. 5 to the Midcap Trust Term Loan, effective as of September 30, 2024, which amended certain affirmative financial covenants. Amendment No. 5 also extended the interest only period from December 1, 2025 until March 1, 2026 (subject to further extension upon certain conditions), at which point we must repay the principal amounts in equal monthly installments until the maturity date of November 1, 2027. Finally, Amendment No. 5 increased the exit fee from 4.75% to 6.25%.
In May 2025, we entered into Limited Waiver and Amendment No. 6 (“Amendment No. 6”) to the Midcap Trust Term Loan pursuant to which, among other things, Midcap Financial Trust, as agent, waived existing events of default as of March 31, 2025 and through the date of Amendment No. 6, and the parties amended certain affirmative financial covenants.
The Midcap Trust Term Loan is collateralized by substantially all of our assets. The agreement contains customary negative covenants that limit our ability to, among other things, incur additional indebtedness, grant liens, make investments, repurchase stock, pay dividends, transfer assets and merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity. The agreement also contains customary affirmative covenants, including requirements to, among other things, deliver audited financial statements. The Midcap Trust Term Loan provides that if we default under the loan and the default is not cured or waived, the lender could cause any
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amounts outstanding to be payable immediately. Under certain circumstances, the lender could also exercise its rights with respect to the collateral securing such loans. Any default under the Midcap Trust Term Loan could limit our ability to obtain additional financing, which may have an adverse effect on our cash flow and liquidity.
We were not in compliance with certain covenants under the Midcap Trust Term Loan as of March 31, 2025. As of the date of this Quarterly Report on Form 10-Q, after giving effect to Amendment No. 6, we are in compliance with all covenants under the Midcap Trust Term Loan as of March 31, 2025 and through the date these consolidated financial statements were issued.
At-the-Market Offering
On November 7, 2022, we entered into the Equity Distribution Agreement with Piper Sandler with respect to an ATM offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Piper Sandler as our sales agent. As of March 31, 2025 and December 31, 2024, we have not sold any shares of common stock under the ATM program.
Cash flows
The following table summarizes our cash flows for the periods presented:
Three months ended | ||||||
March 31, | ||||||
($ in thousands) |
| 2025 |
| 2024 | ||
Net cash (used in) provided by: |
|
|
|
| ||
Operating activities | $ | (7,214) | $ | (20,824) | ||
Investing activities |
| 16,044 |
| (48,817) | ||
Financing activities |
| (250) |
| (444) | ||
Net increase (decrease) in cash, cash equivalents, and restricted cash | $ | 8,580 | $ | (70,085) |
Operating activities
Net cash used in operating activities decreased by $13.6 million to $7.2 million in the three months ended March 31, 2025 compared to $20.8 million in the three months ended March 31, 2024.
Net cash used in operating activities during the three months ended March 31, 2025 consisted of a net loss of $15.7 million, offset by non-cash charges of $5.3 million, and a change in our net operating assets and liabilities of $3.1 million. Non-cash charges primarily consisted of $2.2 million of stock-based compensation expense, $1.8 million of depreciation and amortization, a $0.5 million provision for excess and obsolete inventories, decreases in operating lease right of use assets of $0.4 million, $0.3 million of non-cash interest expense, and a $0.1 million change in fair value of contingent consideration, offset by $0.2 million in accretion of marketable securities. The change in our net operating assets and liabilities was primarily due to increases in accounts payable, accrued expenses and other liabilities of $1.5 million, decreases in accounts receivable of $2.0 million, and decreased inventory levels of $1.0 million, offset by decreases in operating lease liabilities of $0.5 million, a $0.5 million increases in prepaid expenses and other assets, and decreases in deferred revenue of $0.3 million.
Net cash used in operating activities during the three months ended March 31, 2024 consisted of a net loss of $23.5 million and a change in our net operating assets and liabilities of $8.2 million, offset by non-cash charges of $10.9 million. The change in our net operating assets and liabilities was primarily due to increased inventory levels of $7.3 million, decreases in accounts payable, accrued expenses and other liabilities of $3.2 million, decreases in operating lease liabilities of $0.6 million, and decreases in deferred revenue of $0.3 million, offset by decreases in accounts receivable of $3.1 million. Non-cash charges primarily consisted of $3.0 million of impairment expense, $2.6 million of stock-based compensation expense, a $2.3 million adjustment for excess and obsolete inventories, $2.1 million of depreciation and amortization, decreases in operating lease right of use assets of $0.7 million, $0.4 million in credit
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losses for accounts receivable, a $0.2 million change in fair value of contingent consideration, and $0.2 million of non-cash interest expense, offset by $0.5 million in accretion of marketable securities.
Investing activities
Net cash provided by investing activities was $16.0 million for the three months ended March 31, 2025 compared to net cash used in investing activities of $48.8 million during the three months ended March 31, 2024.
Net cash provided by investing activities for the three months ended March 31, 2025 was driven by $20.0 million in maturities of marketable securities, offset by purchases of marketable securities of $3.8 million, and purchases of property and equipment of $0.2 million.
Net cash used in investing activities for the three months ended March 31, 2024 was driven by purchases of marketable securities of $48.0 million and purchases of property and equipment of $0.8 million.
Financing activities
Net cash used in financing activities was $0.3 million for the three months ended March 31, 2025 compared to net cash used in financing activities of $0.4 million for the three months ended March 31, 2024.
Net cash used in financing activities for the three months ended March 31, 2025 was primarily driven by $0.2 million in principal payments on financing leases, and $0.1 million in settlement of restricted stock units for tax withholding obligations.
Net cash used in financing activities for the three months ended March 31, 2024 was primarily driven by $0.2 million in principal payments on financing leases, $0.2 million in payments of deferred offering costs, and $0.1 million in settlement of restricted stock units for tax withholding obligations.
Critical accounting policies and estimates
We have prepared our consolidated financial statements in accordance with GAAP. Our preparation of these consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.
There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 17, 2025.
Recent accounting pronouncements
For information on recently issued accounting pronouncements, see Note 3 – Summary of significant accounting policies to our consolidated financial statements in this Quarterly Report on Form 10-Q.
JOBS Act accounting election
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to avail ourselves of this extended transition period, and, as a result, we will not be required to adopt new or
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revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.
Smaller reporting company status
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million as of the last trading day of our second quarter and our annual revenue is less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million as of the last trading day of our second quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of the last trading day of our second quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. For example, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company, as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of March 31, 2025. There was not any change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) under the Exchange Act) during the quarter ended March 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 17, 2025. The risk factors may be important to understanding other statements in this report and should be read in conjunction with the unaudited financial statements and related notes in this report. The occurrence of any single risk or any combination of risks could materially and adversely affect our business, operations, product pipeline, operating results, financial condition or liquidity, and consequently, the value of our securities. Further, additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and prospects.
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Other than as set forth below, there have been no material changes to the risk factors described in the Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 17, 2025.
The Exchange Ratio is fixed and will not be adjusted in the event of any change in either Quanterix’s or Akoya’s stock price. Therefore, our stockholders cannot be sure of the value of the Merger Consideration they will receive.
Upon completion of the Merger, each issued and outstanding share of our common stock (other than shares held as of the Effective Time by Quanterix, Merger Sub, any direct or indirect wholly owned subsidiary of Quanterix or Akoya or by Akoya as treasury shares) will be converted into the right to receive the Merger Consideration, which is equal to (A) 0.1461 fully paid and nonassessable shares of Quanterix common stock (as may be adjusted in accordance with the Merger Agreement) and, if applicable, cash in lieu of fractional shares and (B) $0.38 in cash, without interest. This Exchange Ratio was fixed in the Merger Agreement and will not be adjusted for changes in the market price of either Akoya common stock or Quanterix common stock. Changes in the market price of Quanterix common stock prior to completion of the Merger would affect the value of the Merger Consideration that Akoya stockholders will receive upon completion of the Merger.
It is impossible to accurately predict the market price of Quanterix common stock at the completion of the Merger and, therefore it is impossible to accurately predict the market value of the shares of Quanterix common stock that Akoya stockholders will receive in the Merger. The market price for Quanterix common stock may fluctuate both prior to the completion of the Merger and thereafter for a variety of reasons, including, among others, general market and economic conditions, the demand for Quanterix’s or Akoya’s products and services, changes in federal, state or local laws and regulations, changes in U.S. governmental regulation of the healthcare industry and other legal developments in the healthcare industry, other changes in Quanterix’s or Akoya’s respective businesses, operations, prospects and financial results of operations, market assessments of the likelihood that the Merger will be completed and/or the value that may be generated by the Merger, and the expected timing of the Merger and regulatory considerations. Many of these factors are beyond Quanterix’s and Akoya’s control and neither Akoya nor Quanterix are permitted to terminate the Merger Agreement solely due to a decline in the market price of a share of the common stock of the other party. As a result, the market value represented by the Exchange Ratio will also vary. Accordingly, at the time of the Akoya Special Meeting, Akoya stockholders will not know or be able to determine the market value of the Merger Consideration they would be entitled to receive upon completion of the Merger.
Upon completion of the Merger, Akoya stockholders will become holders of Quanterix common stock. The market price of the Quanterix common stock will continue to fluctuate, potentially significantly, following completion of the Merger, including for the reasons described above. As a result, former Akoya stockholders could lose some or all of the value of their investment in Quanterix common stock. In addition, any significant price or volume fluctuations in the stock market generally could have a material adverse effect on the market for, or liquidity of, the Quanterix common stock received in the Merger, regardless of the Combined Company’s actual operating performance.
The Merger Consideration is subject to limitations with respect to the maximum aggregate number of shares of Quanterix common stock that may be issued and the maximum aggregate amount of cash that may be payable. As a result, the stock portion and the cash portion of the Merger Consideration payable to Akoya’s stockholders may be subject to change if either limit is exceeded.
The Merger Agreement provides that, in connection with the consummation of the Merger, as contemplated by the Merger Agreement, (i) the aggregate number of shares of Quanterix common stock to be issued by Quanterix will not exceed 19.99% of the issued and outstanding shares of Quanterix common stock immediately prior to the Effective Time and (ii) the aggregate cash consideration to be paid by Quanterix (including cash payable upon vesting of Rollover RSUs (as defined in the Merger Agreement) after the Effective Time) will not exceed $20 million. If any of such limits were to be exceeded, the Exchange Ratio and the Per Share Cash Consideration, as the case may be, would be reduced, with a corresponding increase in the other component (to the extent such increase does not exceed the limitations described in the foregoing sentence).
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Because the Exchange Ratio and the Per Share Cash Consideration may be reduced to ensure the maximum share number and maximum cash amount limitations are satisfied, Akoya stockholders cannot be sure of the value of the Per Share Merger Consideration they will receive relative to the value of shares of Akoya common stock they exchange.
The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms.
The Merger is subject to a number of conditions that must be satisfied (or waived, to the extent permitted), including (i) receipt of the approval by Akoya stockholders; (ii) the registration statement on Form S-4, as amended by any post-effective amendment thereto, has become effective under the Securities Act and not being the subject of any action by the SEC seeking a stop order; (iii) the waiting period applicable to the Merger under the HSR Act having expired or been terminated, any mandatory waiting period or required clearance, approval or consent applicable to the Merger under any other applicable competition or antitrust law having expired or been obtained (except where the failure to observe such waiting period or obtain a clearance, approval or consent would not have a material adverse effect), and each other clearance, approval or consent with respect to the Merger by any relevant governmental authority asserting jurisdiction under any other applicable antitrust law having been deemed to be cleared, approved or consented to under such other antitrust laws; (iv) the absence of any order issued or entered, or any law enacted or promulgated, after the date of the Merger Agreement by any governmental body and having the effect of restraining, enjoining, making illegal or otherwise prohibiting the consummation of the Merger or the other transactions contemplated by the Merger Agreement; (v) the submission by Quanterix to Nasdaq of a notification of shares of Quanterix common stock to be issued in connection with the Merger (including those to be reserved upon exercise of options to acquire shares of Akoya common stock and the settlement of restricted stock units in respect of shares of Akoya common stock) as contemplated by the Merger Agreement; (vi) subject to certain exceptions, the accuracy of the representations and warranties of the parties to the Merger Agreement; (vii) performance by each party of its respective obligations under the Merger Agreement; and (viii) the absence of a “Material Adverse Effect” (as defined in the Merger Agreement) with respect to each of Akoya and Quanterix. These conditions to the completion of the Merger, some of which are beyond the control of Quanterix and Akoya, may not be satisfied or waived in a timely manner or at all, and, accordingly, the Merger may be delayed or not completed.
Generally, each party has incurred and will incur costs in connection with entering into the Merger Agreement and consummating the transactions contemplated thereby (many of which will be payable by each of the respective parties whether or not the Merger is completed). Additionally, either Quanterix or Akoya may terminate the Merger Agreement under certain circumstances, subject to the payment of a termination fee in certain cases.
The Merger Agreement provides that we will pay Quanterix a termination fee of $2.6 million in certain circumstances. The termination fee contemplated by the Merger Agreement may have the effect of discouraging alternative transaction proposals involving Akoya.
Changes in United States trade policies, including the imposition of tariffs, may adversely impact our business, financial condition, and results of operations.
During the first Trump Administration from 2017 to 2021, certain tariffs, as well as other trade restrictions, were imposed on various imported products and materials. President Trump again has signaled that his new Administration will impose tariffs against certain U.S. trading partners. On February 1, 2025, President Trump issued an Executive Order imposing tariffs at various levels on imports from Canada, Mexico, and China. The newly imposed tariffs triggered immediate threats of retaliatory tariffs against U.S. goods and have resulted in discussions with the affected countries which have delayed the implementation of many of the U.S. imposed tariffs while discussions with each trading partner continue. In March and April 2025, the Trump Administration announced a series of additional special tariffs, some of which have been temporarily paused. The additional special tariffs already in effect as of the date of this periodic report on Form 10-Q include tariffs on certain aluminum and steel products and certain derivatives as well as tariffs of 10% on most products from all countries worldwide, and a 145% tariff on substantially all products of Chinese origin.
These dynamic conditions are causing some reservations from consumers and businesses alike, which may impact buying decisions and mimic recessionary conditions. This in turn could adversely affect our financial condition and
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results of operations. In addition, to the extent changes in the political environment have a negative impact on us or on the markets in which we operate our business, our results of operations and financial condition could be materially and adversely impacted in the future. At this time, it remains unclear what the U.S. government or foreign governments will or will not do with respect to additional tariffs that may be imposed or international trade agreements and policies.
There is substantial uncertainty regarding the new administration’s initiatives and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed toward other government agencies. These initiatives could prevent, limit or delay development and regulatory approval of our future diagnostic products, or limit our customers’ ability to purchase our products and services, which would adversely affect our business.
We face substantial uncertainty with regard to the regulatory environment we will face following the inauguration of President Trump in January 2025. Certain initiatives have manifested to date in the form of personnel measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays or limitations on our ability to obtain guidance from the FDA on our diagnostic products in development and obtain the requisite regulatory approvals in the future. Moreover, the new administration has proposed action to freeze or reduce the budget of the National Institute of Health (“NIH”) as related to its funding for medical research, which could decrease the ability of certain of our customers that rely on NIH funding to make capital expenditures. There remains general uncertainty regarding future activities. The new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or our customers or create a more challenging or costly environment to pursue the development of new products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. If we or our customers become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the new administration, there could be a material adverse effect on us and our business.
Our Midcap Trust Term Loan contains financial covenants which we may be unable to meet and we may be required to repay the outstanding indebtedness in an event of default, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
In October 2020, we entered into a credit and security agreement with Midcap Financial Trust, pursuant to which the Lender agreed to provide us a $37.5 million credit facility (the “Midcap Trust Term Loan”).
On March 21, 2022, we entered into Amendment No. 1 to the Midcap Trust Term Loan, which amended certain provisions to permit certain additional debt and capital leases.
On June 1, 2022, we entered into Amendment No. 2 (“Amendment No. 2”) to the Midcap Trust Term Loan, which permitted the draw of a second tranche of $10.0 million, which was drawn on June 1, 2022. Additionally, the amendment provided us with a new third tranche pursuant to which we were permitted to draw $10.0 million any time after September 30, 2022 until September 30, 2023. The amendment also delayed the amortization start dates for the outstanding loan amounts from November 1, 2023 until April 1, 2025, at which point we would be obligated to repay the principal amounts in seven equal monthly installments until the maturity date. Finally, Amendment No. 2 amended the interest rate payable on the term loan to apply an interest rate equal to the Secured Overnight Financing Rate (“SOFR”) rate (with a floor of 1.61448%) plus 6.35%. Substantially all other terms and conditions, and covenants of the credit agreement remained unchanged. In connection with Amendment No. 2, the Company agreed to pay a $75.0 thousand commitment fee as well as a 0.25% fee upon the funding of each of the second tranche and third tranche amounts. On September 30, 2022, the Company drew the third tranche of $10.0 million related to Amendment No. 2.
On November 7, 2022, we entered into Amendment No. 3 (“Amendment No. 3”) to the Midcap Trust Term Loan, which permitted the draw of two additional tranches, each totaling $11.25 million, which were drawn on November 7, 2022 and December 22, 2023, respectively. The amendment also delayed the amortization start dates for the outstanding loan amounts from April 1, 2025 until December 1, 2025 (subject to further extension upon certain conditions), at which point we would be obligated to repay the principal amounts in equal monthly installments until the new maturity date of November 1, 2027, which was extended pursuant to Amendment No. 3. In addition, Amendment No. 3 amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 2.50%) plus 6.80%,
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and reset the call protection to begin as of November 7, 2025. Finally, Amendment No. 3 provided for a commitment fee of $74 thousand that was paid on November 7, 2022 on the new tranche amounts and an exit fee of 4.75%. Substantially all other terms and conditions, and covenants of the credit agreement remained unchanged.
In July 2024, we entered into Amendment No. 4 (“Amendment No. 4”) to the Midcap Trust Term Loan, which amended certain affirmative financial covenants.
In November 2024, we entered into Amendment No. 5 (“Amendment No. 5”) to the Midcap Trust Term Loan, effective as of September 30, 2024, which amends certain affirmative financial covenants. Amendment No. 5 also extends the interest only period from December 1, 2025 until March 1, 2026 (subject to further extension upon certain conditions), at which point we must repay the principal amounts in equal monthly installments until the maturity date of November 1, 2027. Finally, Amendment No. 5 increases the exit fee from 4.75% to 6.25%.
In May 2025, we entered into Limited Waiver and Amendment No. 6 (“Amendment No. 6”) to the Midcap Trust Term Loan, pursuant to which, among other things, Midcap Financial Trust, as agent, waived existing events of default as of March 31, 2025 and through the date of Amendment No. 6 and the parties amended certain affirmative financial covenants.
If the transaction contemplated under our Merger Agreement with Quanterix is not consummated, based on our current operating plan, we do not expect to maintain compliance with certain financial covenants at July 31, 2025 under the Midcap Trust Term Loan. In such event, we would intend to seek a waiver, refinance the outstanding borrowings or otherwise mitigate these concerns with Midcap Financial Trust or another lender. There can be no assurance that an amendment or waiver will be granted or that we will be able to refinance the amounts outstanding, and in such an event, the lender may exercise any and all of its rights and remedies provided for under the Midcap Trust Term Loan, including exercising its rights as secured lender to take possession of and to dispose of the collateral securing the Midcap Trust Term Loan, which collateral includes substantially all of our property. Our business, financial condition, results of operations and prospects could be materially adversely affected as a result of any of these events.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Midcap Amendment
On May 12, 2025, we entered into Amendment No. 6, pursuant to which, among other things, Midcap Financial Trust, as agent, waived existing events of default as of March 31, 2025 and through the date of Amendment No. 6 and the parties amended certain affirmative financial covenants. Additionally, Amendment No. 6 included certain additional restrictive covenants, including amending or modifying our Amendment and Restated Agreement and Plan of Merger, dated April 28, 2025, by and among us, Quanterix and Wellfleet Merger Sub, Inc. which are reasonably expected to be materially adverse to Midcap’s interest. Substantially all other term and conditions, and covenants of the Midcap Trust Term Loan remain unchanged.
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The foregoing summary of Amendment No. 6 is qualified in its entirety by the full text of Amendment No. 6, a copy of which will be filed on our Quarterly Report on Form 10-Q for the period ending June 30, 2025.
Rule 10b5-1 Plan Disclosure
During the first quarter of 2025, no directors or officers
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Item 6. Exhibits
Incorporated by Reference | ||||||||||||
Exhibit |
| Exhibit Title |
| Form |
| File No. |
| Exhibit |
| Filing Date |
| Filed |
2.1+ | ||||||||||||
2.2+ | ||||||||||||
101.INS | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) | X | ||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents | X | ||||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | X | ||||||||||
+Certain exhibits and schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Akoya hereby undertakes to furnish supplemental copies of any of the omitted exhibits and schedules upon request by the SEC; provided, however, that Akoya may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any exhibits or schedules so furnished.
†Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information is not material and would be competitively harmful if publicly disclosed.
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*This certification is deemed not filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Akoya Biosciences, Inc. | ||
---|---|---|
Date: May 12, 2025 | By: | /s/ Brian McKelligon |
Brian McKelligon | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: May 12, 2025 | By: | /s/ Johnny Ek |
Johnny Ek | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
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