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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
Commission File No.
|
Catheter Precision, Inc. |
|
(Exact name of registrant as specified in its charter) |
|
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|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
|
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|
(Address of principal executive offices) |
(Zip Code) |
|
(
|
|
(Registrant ’ s telephone number, including area code) |
|
N/A |
|
(Former name, former address and former fiscal year, if changed since last report) |
Securities Registered under Section 12(b) of the Act:
|
Title of each class: |
Trading Symbol(s) |
Name of each exchange on which registered: |
||
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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
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
|
|
☒ |
Smaller reporting company |
|
|
Emerging growth company |
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act). Yes
As of the close of business o
n November 7,
2025, the registrant had
CATHETER PRECISION, INC.
QUARTERLY REPORT ON FORM 10-Q
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
|
September 30, 2025 |
December 31, 2024 |
|||||||
| (Unaudited) | ||||||||
|
ASSETS |
||||||||
|
Current Assets |
||||||||
|
Cash and cash equivalents |
$ |
|
$ |
|
||||
|
Trading debt securities |
|
|
||||||
|
Accounts receivable, net |
|
|
||||||
|
Inventories |
|
|
||||||
|
Prepaid expenses and other current assets |
|
|
||||||
|
Total current assets |
|
|
||||||
|
Property and equipment, net |
|
|
||||||
|
Operating lease right-of-use assets, net |
|
|
||||||
|
Intangible assets, net |
|
|
||||||
|
Other non-current assets |
|
|
||||||
|
TOTAL ASSETS |
$ |
|
$ |
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
|
Current Liabilities |
||||||||
|
Accounts payable |
$ |
|
$ |
|
||||
|
Accrued expenses |
|
|
||||||
|
Short-term notes payable |
|
|
||||||
|
Current portion of notes payable due to related parties |
|
|
||||||
|
Short-term notes payable of variable interest entities due to related parties |
|
|
||||||
|
Current portion of royalties payable due to related parties |
|
|
||||||
|
Current portion of operating lease liabilities |
|
|
||||||
|
Total current liabilities |
|
|
||||||
|
Royalties payable due to related parties |
|
|
||||||
|
Operating lease liabilities |
|
|
||||||
|
Notes payable of variable interest entities, net of discount |
|
|
||||||
|
Notes payable due to related parties |
|
|
||||||
|
Deferred tax liability |
|
|
||||||
|
Total liabilities |
|
|
||||||
|
Commitments and Contingencies (see Note 16) |
||||||||
|
Stockholders' Equity |
||||||||
|
Preferred Stock, $ par value, shares authorized |
||||||||
|
Series A Convertible Preferred Stock, $ par value, shares designated; shares issued and outstanding as of September 30, 2025 and December 31, 2024 |
|
|
||||||
|
Series B Convertible Preferred Stock, $ par value, shares designated; and shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively |
|
|
||||||
|
Series X Convertible Preferred Stock, $ par value, shares designated; shares issued and outstanding as of September 30, 2025 and December 31, 2024 |
|
|
||||||
|
Common stock, $ par value, shares authorized; and shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively |
|
|
||||||
|
Additional paid-in capital |
|
|
||||||
|
Accumulated deficit |
(
|
) |
(
|
) | ||||
|
Total stockholders' equity attributable to Catheter Precision, Inc. |
|
|
||||||
|
Non-controlling interest |
(
|
) |
|
|||||
|
Total stockholders' equity |
|
|
||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
|
$ |
|
||||
See accompanying notes to unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
|
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||
|
Revenues |
$ |
|
$ |
|
$ |
|
$ |
|
||||
|
Cost of revenues |
|
|
|
|
||||||||
|
Gross profit |
|
|
|
|
||||||||
|
Operating expenses |
||||||||||||
|
Selling, general and administrative |
|
|
|
|
||||||||
|
Research and development |
|
|
|
|
||||||||
|
Acquired in-process research and development |
|
|
|
|
||||||||
|
Total operating expenses |
|
|
|
|
||||||||
|
Operating loss |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||
|
Other income (expenses), net |
||||||||||||
|
Interest income |
|
|
|
|
||||||||
|
Interest expense |
(
|
) |
|
(
|
) |
(
|
) | |||||
|
Interest expense due to related parties |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||
|
Change in fair value of royalties payable due to related parties |
|
(
|
) |
(
|
) |
(
|
) | |||||
|
Change in fair value of trading debt securities |
|
|
|
|
||||||||
|
Other expenses, net |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||
|
Total other income (expenses), net |
|
(
|
) |
(
|
) |
(
|
) | |||||
|
Loss from operations before income tax benefit (provision) |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||
|
Income tax benefit (provision) |
(
|
) |
|
|
|
|||||||
|
Net loss |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||
|
Less: Net loss attributable to non-controlling interest |
(
|
) |
|
(
|
) |
|
||||||
|
Net loss attributable to Catheter Precision, Inc. |
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) |
|
Net loss per share attributable to Catheter Precision, Inc., basic and diluted |
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) |
|
Weighted-average common shares used in computing net loss per share, basic and diluted |
|
|
|
|
||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Stockholders' Equity
(in thousands, except share data)
(Unaudited)
|
Total |
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Series A Convertible Preferred Stock |
Series B Convertible Preferred Stock |
Series X Convertible Preferred Stock |
Common Stock |
Additional Paid-In |
Accumulated |
Catheter Precision Inc. Stockholders' |
Non-controlling |
Total Stockholders' |
||||||||||||||||||||||||||||||||||||||||||||
|
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Equity |
Interest |
Equity |
||||||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
|
$ |
|
$ |
|
|||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock for vested restricted stock awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock for asset acquisition (see Note 14) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock upon release of Prepaid Series Warrants (see Note 11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Net loss |
— | — | — | — | — | — | — | — | — |
(
|
) |
(
|
) |
|
(
|
) | ||||||||||||||||||||||||||||||||||||
|
Balance at March 31, 2025 |
|
|
|
|
|
|
|
|
|
(
|
) |
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock for vested restricted stock awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock for asset acquisition (see Note 14) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock upon release of Prepaid Series Warrants (see Note 11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of preferred stock and warrants under the May 2025 PIPE Financing, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock upon the ATM Offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Conversion of preferred stock |
|
|
(
|
) |
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Issuance of VIE shares to non-controlling interest |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Net loss |
— | — | — | — | — | — | — | — | — |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||||
|
Balance at June 30, 2025 |
|
|
|
|
|
|
|
|
|
(
|
) |
|
(
|
) |
|
|||||||||||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock for vested restricted stock awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock upon the ATM Offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Net loss |
— |
|
— |
|
— |
|
— |
|
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||||
|
Balance at September 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
|
$ |
(
|
) | $ |
|
||||||||||||||||||||||||||||
|
Total |
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Series A Convertible Preferred Stock |
Series B Convertible Preferred Stock |
Series X Convertible Preferred Stock |
Common Stock |
Additional Paid-In |
Accumulated |
Catheter Precision Inc. Stockholders' |
Non-controlling |
Total Stockholders' |
||||||||||||||||||||||||||||||||||||||||||||
|
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Equity |
Interest |
Equity |
||||||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
|
$ |
|
$ |
|
|||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Conversion of Series A Convertible Preferred Stock |
(
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Net loss |
— | — | — | — | — | — | — | — | — |
(
|
) |
(
|
) |
|
(
|
) | ||||||||||||||||||||||||||||||||||||
|
Balance at March 31, 2024 |
|
|
|
|
|
|
|
|
|
(
|
) |
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Net loss |
— | — | — | — | — | — | — | — | — |
(
|
) |
(
|
) |
|
(
|
) | ||||||||||||||||||||||||||||||||||||
|
Balance at June 30, 2024 |
|
|
|
|
|
|
|
|
|
(
|
) |
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock and other equity-classified contracts from September 2024 Public Offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Issuance of common stock upon exercise of Pre-Funded Warrants (see Note 11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Conversion of Series A Convertible Preferred Stock |
(
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||
|
Stock-based compensation |
— |
|
— |
|
— |
|
— |
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
|
Net loss |
— |
|
— |
|
— |
|
— |
|
|
(
|
) |
(
|
) |
|
(
|
) | ||||||||||||||||||||||||||||||||||||
|
Balance at September 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
|
$ |
|
$ |
|
|||||||||||||||||||||||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
|
For the Nine Months Ended September 30, |
||||||
|
2025 |
2024 |
|||||
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||
|
Net loss |
$ |
(
|
) | $ |
(
|
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||
|
Depreciation and amortization |
|
|
||||
|
Stock-based compensation |
|
|
||||
|
Change in fair value of royalties payable due to related parties |
|
|
||||
|
Change in fair value of trading debt securities |
(
|
) |
|
|||
|
Deferred income tax benefit |
(
|
) |
|
|||
|
Acquired in-process research and development |
|
|
||||
|
Amortization of discount on note payable |
|
|
||||
|
Changes in operating assets and liabilities: |
||||||
|
Accounts receivable |
(
|
) |
|
|||
|
Inventories |
(
|
) |
(
|
) | ||
|
Prepaid expenses and other current assets |
|
|
||||
|
Operating lease right-of-use assets and lease liabilities |
(
|
) |
(
|
) | ||
|
Current portion of royalties payable due to related parties |
|
|
||||
|
Accounts payable |
|
|
||||
|
Accrued expenses |
|
(
|
) | |||
|
Interest payable due to related parties |
|
|
||||
|
Interest accrued on notes payable of variable interest entities |
|
|
||||
|
Net cash used in operating activities |
(
|
) |
(
|
) | ||
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||
|
Purchases of acquired in-process research and development |
(
|
) |
|
|||
|
Purchases of property and equipment |
(
|
) |
(
|
) | ||
|
Net cash used in investing activities |
(
|
) |
(
|
) | ||
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||
|
Proceeds from issuance of Series B Convertible Preferred Stock and other equity-classified warrants, net of issuance costs |
|
|
||||
|
Proceeds from issuance of common stock and other equity-classified contracts from the September 2024 Public Offering, net of issuance costs |
|
|
||||
|
Proceeds from issuance of common stock under ATM, net of issuance costs |
|
|
||||
|
Proceeds from notes payable due to related parties |
|
|
||||
|
Payments on notes payable |
(
|
) |
(
|
) | ||
|
Proceeds from notes payable |
|
|
||||
|
Net cash provided by financing activities |
|
|
||||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS |
(
|
) |
(
|
) | ||
|
CASH AND CASH EQUIVALENTS, beginning of period |
|
|
||||
|
CASH AND CASH EQUIVALENTS, end of period |
$ |
|
$ |
|
||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION |
||||||
|
Cash paid for interest |
$ |
|
$ |
|
||
|
SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING AND INVESTING ACTIVITIES |
||||||
|
Property and equipment reclassified from inventories |
$ |
|
$ |
|
||
|
Note payable of variable interest entities issued in connection with an asset acquisition |
$ |
|
$ |
|
||
|
Fair value of common stock issued in connection with asset acquisitions |
$ |
|
$ |
|
||
|
Consideration for asset acquisition included in accounts payable |
$ |
|
$ |
|
||
|
Consideration for asset acquisition included in non-controlling interest |
$ |
|
$ |
|
||
|
Fair value of trading debt securities obtained as consideration for the Series B Convertible Preferred Stock and other equity-classified warrants |
$ |
|
$ |
|
||
|
Operating right-of-use asset obtained in exchange for new operating lease liabilities |
$ |
|
$ |
|
||
See accompanying notes to unaudited condensed consolidated financial statements.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. Organization and Nature of Operations
The Company
Catheter Precision, Inc. ("Catheter" or the "Company”) was incorporated in California on September 4, 2002, and reincorporated in Delaware in July 2018.
On January 9, 2023, Catheter entered into the Amended and Restated Agreement and Plan of Merger (the "Merger Agreement") with Catheter Precision, Inc. (“Old Catheter”), a privately held Delaware corporation. Under the terms of the Merger Agreement, Old Catheter became a wholly owned subsidiary of Catheter, together referred to as the Company, in a stock-for-stock merger transaction (the "Merger"). The Company’s current operating activities primarily relate to Old Catheter’s historical business, which comprises the design, manufacture and sale of new and innovative medical technologies in the field of cardiac electrophysiology (“EP”).
One of the Company’s two primary products is the VIVO System, which is an acronym for View into Ventricular Onset (“VIVO” or “VIVO System”). VIVO is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures. The VIVO System is commercially available in the European Union and has been placed at several hospitals in Europe. United States Food and Drug Administration ("FDA") 510 (k) clearance was received, and the Company began commercial sales of VIVO in 2021 in the United States.
The Company’s second primary product, LockeT® (“LockeT”), is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure and is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. In addition, LockeT is a sterile, Class I product that was registered with the FDA in February 2023, at which time initial shipments began to distributors. Clinical studies for LockeT began during the year ended December 31, 2023. These studies are planned to show the product’s effectiveness and benefits, including faster wound closure and patient ambulation/discharge, potentially resulting in higher procedural volumes and lower costs for the healthcare provider and/or insurance payor. This information is intended to provide crucial data that will improve marketability by establishing the effectiveness of the medical device and a competitive advantage. The Company recorded its first commercial sale of LockeT to distributors in May 2024. In April 2025, a U.S. patent for the product was granted by the United States Patent and Trademark Office. In April 2025, the Company also obtained the CE Mark approval for LockeT, permitting the marketing and sale of LockeT in the European Union, Switzerland and Turkey. Since receipt of the CE Mark, the Company has signed agreements with new distributors in the United Kingdom, Italy, Spain, Portugal, Switzerland, the Middle East, South Africa and Brunei.
The Company’s product portfolio also includes the Amigo® Remote Catheter System (the "AMIGO" or "AMIGO System"), a robotic arm that serves as a catheter control device. The Company owns the intellectual property related to AMIGO, and this product is under consideration for future research and development of a generation 2 product.
On
February 17, 2025,
the Company formed a new subsidiary, Cardionomix, Inc. ("Cardionomix"), to acquire certain assets previously held by Cardionomic, Inc. ("Cardionomic"), a
third
party entity that has ceased operations. The Company owns
On May 5, 2025, Cardionomix acquired certain assets primarily related to Cardionomics' Cardiac Pulmonary Nerve Stimulation (“CPNS”) System, which is a novel technology for the late-stage treatment of acute decompensated heart failure. The CPNS System consists of electrical simulation via a temporary catheter inserted into the pulmonary artery that targets the root cause of heart failure by stimulating the autonomic cardiac nerves to restore autonomic balance. The CPNS System has not yet left the development stage or been submitted for regulatory approval.
On June 20, 2025, the Company formed a new subsidiary, KardioNav, Inc. ("KardioNav"), to pursue the advancement, development, and commercialization of electrophysiology mapping technologies. The Company assigned certain intellectual property related to the VIVO System which it is not currently developing to KardioNav, while Chelak iECG ("Chelak"), an unrelated third party, assigned certain intellectual property related to technology designed to interface with implanted cardiac devices to facilitate improved pre-ablation mapping and localization of arrhythmogenic tissue. The intellectual property assigned by Chelak consisted solely of patents and related know-how at a conceptual stage, the development of which has not yet been advanced into a developed technology or product. KardioNav intends to integrate the Company’s VIVO mapping intellectual property with Chelak’s patents to develop a system that interfaces with implanted cardiac devices to enable improved pre-ablation mapping and more precise localization of arrhythmogenic tissue. Research and development activities in animals and humans commenced during September 2025.
The Company owns
Reverse Stock Split
On
January 13, 2025,
at a Special Meeting of Stockholders of the Company, the stockholders approved an amendment to the Amended and Restated Certificate of Incorporation of the Company, which included an increase in the authorized capital stock to
On
July 25, 2025,
at the annual meeting of stockholders of the Company, the stockholders approved an amendment to the Amended and Restated Certificate of Incorporation of the Company (the “Amendment”) to effect a reverse stock split within specified parameters.
The Board approved the Amendment and set the ratio of the reverse stock split at
1
-for-
19.
The Amendment was effective
August 15, 2025,
effecting a reverse stock split in which each
nineteen
(
No fractional shares were issued as a result of the reverse stock split. Stockholders who would otherwise have been entitled to receive a fractional share were entitled to receive their pro rata portion of the net proceeds obtained from the aggregation and sale by the exchange agent of the fractional shares resulting from the reverse stock split (reduced by any customary brokerage fees, commissions and other expenses). All references to share and per share amounts for all periods presented in the unaudited condensed consolidated financial statements have been retrospectively restated to reflect this reverse stock split. All rights to receive shares of common stock under outstanding securities, including but not limited to, warrants and options, were adjusted to give effect to the reverse stock split. Furthermore, proportionate adjustments were made to the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding warrants and stock options granted by the Company, and the number of shares of common stock reserved for future issuance under the Company’s Equity Incentive Plan.
Going Concern
The unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from uncertainty related to its ability to continue as a going concern.
The Company has incurred recurring net losses from operations and negative cash flows from operating activities since inception. For the
nine
months ended
September 30, 2025
, the Company incurred
$
Management expects operating losses and negative cash flows to continue for the foreseeable future. The Company needs to raise additional capital until it is able to generate revenues from operations sufficient to fund its research, development, and commercial operations. On
May 12, 2025,
the Company entered into a Securities Purchase Agreement for a private placement with
institutional investors. Pursuant to the Securities Purchase Agreement, the Company sold an aggregate of (i)
Management estimates that based on the Company’s liquidity resources and currently anticipated expenses, if it is unable to secure additional financing it will be unable to fund planned expenditures and meet obligations through the end of the fourth quarter 2025, and there is substantial doubt about the Company’s ability to continue as a going concern within 12 months from the date of issuance of the unaudited condensed consolidated financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared on the basis of the Company continuing to operate in the normal course of business and do not reflect any adjustments to the assets and liabilities related to the substantial doubt of its ability to continue as a going concern.
Management plans to raise additional capital through public or private equity or debt financing, or other innovative and specialty finance strategies such as crypto asset treasury policy, in order to fulfill its operating and capital requirements for at least 12 months from the date of the issuance of the unaudited condensed consolidated financial statements. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The unaudited condensed consolidated financial statements of the Company include the accounts of the Company, Old Catheter, Cardionomix and KardioNav. All intercompany transactions have been eliminated in consolidation.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP") applicable to interim financial statements. The Financial Accounting Standards Board (“FASB”) establishes these principles to ensure financial condition, results of operations, and cash flows are consistently reported. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative nongovernmental GAAP as found in the FASB Accounting Standards Codification ("ASC"). Certain footnotes and other financial information normally required by U.S. GAAP have been condensed or omitted in accordance with instructions to Form 10 -Q and Article 8 of Regulation S- X. In the opinion of management, such statements include all adjustments which are considered necessary for fair presentation of the unaudited condensed consolidated financial statements of the Company. The operating results presented herein are not necessarily an indication of the results that may be expected for the year. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in its Annual Report on Form 10 -K for the year ended December 31, 2024 , as filed with the Securities and Exchange Commission (“SEC”) on March 31, 2025.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. The Company’s unaudited condensed consolidated financial statements are based upon a number of estimates including, but not limited to, the allowance for credit losses, evaluation of impairment of long-lived assets, valuation of long-lived assets and their associated estimated useful lives, reserves for warranty costs, evaluation of probable loss contingencies, fair value of royalties payable due to related parties, fair value of contingent consideration recorded in connection with an asset acquisition, fair value of trading debt securities, fair value of warrants issued, and fair value of equity awards granted.
Concentrations of Credit Risk
The Company's financial instruments held during the
nine
month periods ended
September 30, 2024
and
September 30, 2025
that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company generally maintains cash and cash equivalent balances in various operating accounts at financial institutions with high quality credit ratings in amounts in excess of federally insured limits of
$250,000.
As of
September 30, 2025
, the Company had deposits in financial institutions in excess of federally insured limits of $
The Company extends credit to customers in the normal course of business. Concentrations of credit risk with respect to accounts receivable exist to the full extent of amounts presented in the condensed consolidated balance sheets. The Company does not require collateral from its customers to secure accounts receivable.
The Company had
The Company had
The Company had
The Company is not dependent on any single supplier for critical components.
Reclassifications
Certain prior period financial statement amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the Company's previously reported results of operations or accumulated deficit. In the current period, the Company (i) presents royalty fees incurred and payable based on actual sales of products as well as future estimated royalty payments payable within the next 12 months under current portion of royalties payable due to related parties in the condensed consolidated balance sheets, (ii) interest payable due to related parties and notes payable due to related parties is aggregated and presented as notes payable due to related parties in the condensed consolidated balance sheets, (iii) current portion of interest payable due to related parties and current portion of notes payable due to related parties is aggregated and presented as current portion of notes payable due to related parties in the condensed consolidated balance sheets and (iv) separately discloses interest expense due to related parties in the condensed consolidated statements of operations. For comparative purposes, amounts in the prior periods have been reclassified to conform to current period presentations.
Segment Reporting
The Company operates in reportable segment, which includes all activities related to the marketing, sales, and development of medical technologies in the cardiac electrophysiology field. While the commercial efforts that coordinate the marketing, sales, and distribution of these products are organized by geographic region and product, all of these activities are supported by a single corporate team and distribution channels. The determination of a single reportable segment is consistent with the condensed consolidated financial information available and regularly reviewed by the Company’s chief operating decision maker (“CODM”).
The CODM is the Company’s chief executive officer, who reviews and evaluates condensed consolidated net loss reported on the condensed consolidated statements of operations for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. As the Company’s operations are managed at the consolidated level, there are no differences between the measurement of the reportable segments’ profit or losses and the Company’s condensed consolidated statements of operations. Segment asset measures are not used as a basis for the CODM to evaluate the performance of or to allocate resources to the segment.
The following table summarizes segment revenues and significant segment expenses included in the measure of segment profit or loss (consolidated net loss) reviewed by the CODM (in thousands):
|
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||||||
|
September 30, |
September 30, |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Revenues |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Less: |
||||||||||||||||
|
Cost of revenues |
|
|
|
|
||||||||||||
|
Acquired in-process research and development expense |
|
|
|
|
||||||||||||
|
Depreciation and amortization expense |
|
|
|
|
||||||||||||
|
Stock-based compensation expense |
|
|
|
|
||||||||||||
|
Salaries and benefits expense |
|
|
|
|
||||||||||||
|
Professional fees |
|
|
|
|
||||||||||||
|
Research and development expense |
|
|
|
|
||||||||||||
|
Interest income |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Interest expense |
|
|
|
|
||||||||||||
|
Change in fair value of royalties payable due to related parties |
(
|
) |
|
|
|
|||||||||||
|
Change in fair value of trading debt securities |
(
|
) |
|
(
|
) |
|
||||||||||
|
Income tax benefit |
|
|
(
|
) |
|
|||||||||||
|
Other segment items (1) |
|
|
|
|
||||||||||||
|
Segment net loss |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Reconciliation of net loss |
||||||||||||||||
|
Adjustments and reconciling items |
|
|
|
|
||||||||||||
|
Consolidated net loss |
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||
( 1 ) Other segment items include other expenses, net, consulting fees, investor relations and SEC fees, insurance fees, and other selling, general, and administrative expenses. Other selling, general, and administrative expenses primarily consist of travel expenses, computer and information technology expenses, and rent expenses.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity date of ninety days or less at the date of purchase to be cash equivalents. Cash and cash equivalents primarily represent funds invested in readily available checking and money market accounts.
Fair Value Measurements
Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three -tier fair value hierarchy is used to identify inputs used in measuring fair value as follows:
Level 1 - Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
Level 2 - Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
Level 3 - Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.
Cash equivalents, prepaid expenses, accounts receivable, accounts payable, and accrued expenses are reported on the condensed consolidated balance sheets at carrying value, which approximate fair value due to the short-term maturities of these instruments. The carrying value of the Company's short-term notes payable and notes payable due to related parties approximate the instruments' fair values due to the short-term maturities of these debt instruments. Similarly, the carrying value of the notes payable of variable interest entities approximates its fair value due to the associated effective interest rate of the debt instrument.
The following table details the fair value measurements within the fair value hierarchy of the Company’s financial instruments (in thousands):
|
September 30, 2025 |
||||||||||||||||
|
Total |
Level 1 |
Level 2 |
Level 3 |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Cash Equivalents |
||||||||||||||||
|
Mutual funds |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Money market funds |
|
|
|
|
||||||||||||
|
Trading debt securities |
|
|
|
|
||||||||||||
|
Total assets |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Liabilities: |
||||||||||||||||
|
Current portion of royalties payable due to related parties |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Royalties payable due to related parties |
|
|
|
|
||||||||||||
|
Total liabilities |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
December 31, 2024 |
||||||||||||||||
|
Total |
Level 1 |
Level 2 |
Level 3 |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Cash Equivalents |
||||||||||||||||
|
Mutual funds |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Money market funds |
|
|
|
|
||||||||||||
|
Total assets |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Liabilities: |
||||||||||||||||
|
Current portion of royalties payable due to related parties |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Royalties payable due to related parties |
|
|
|
|
||||||||||||
|
Total liabilities |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
The fair value measurement of royalties payable due to related parties includes significant unobservable inputs that are not supported by any market data. Royalties payable due to related parties equals the present value of estimated future royalty payments. The Company applies an internally developed, revenue adjusted discount rate (“RADR”) to discount back the forecasted royalty payments. The RADR is based on the Company’s weighted average cost of capital (“WACC”) adjusted for the product revenue’s risk profile. The risk-free rate used to determine the cost of equity for the RADR is adjusted to be commensurate with the term of the royalty agreements. Furthermore, the Beta and Risk Premium used to determine the cost of equity are also adjusted to reflect the product revenue's volatility. All other inputs for the RADR and the Company’s WACC are the same.
The fair value of trading debt securities includes assumptions that are both significant and unobservable. The fair value of the trading debt securities is determined using a probability weighted expected return model (“PWER model”) that values the trading debt securities based on the discounted cash flows of two potential settlement outcomes: (i) the trading debt securities will be converted into and settled in shares of common stock of QHSLab, Inc. and (ii) the trading debt securities’ principal and accrued interest will be paid in cash. Aside from the probability of the two potential settlement outcomes, the fair value measurement incorporates several significant unobservable inputs, including the recovery rate, simulated conversion price, credit-risk adjusted discount rate, expected equity volatility, and expected term for conversion and for payment.
The following tables summarize the significant unobservable inputs used in the fair value measurement of Level 3 instruments:
|
September 30, 2025 |
||||||
|
Instrument |
Valuation Technique |
Unobservable Input |
Input Range |
|||
|
Royalties payable due to related parties |
Discounted future cash flows |
Revenue adjusted discount rate |
|
% | ||
|
Trading debt securities |
Probability weighted expected return |
Recovery rate |
|
% | ||
|
Simulated conversion price |
$ |
|
||||
|
Credit risk-adjusted discount rate |
|
% | ||||
|
Expected equity volatility |
|
% | ||||
|
Probability of conversion |
|
% | ||||
|
Probability of payment |
|
% | ||||
|
Expected term for conversion (years) |
|
|||||
|
Expected term for payment (years) |
|
|||||
|
December 31, 2024 |
||||||
|
Instrument |
Valuation Technique |
Unobservable Input |
Input Range |
|||
|
Royalties payable due to related parties |
Discounted future cash flows |
Revenue adjusted discount rate |
|
% | ||
The table below summarizes the change in fair value of royalties payable due to related parties and trading debt securities for the three and nine months ended September 30, 2025 (in thousands):
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
||||||||
|
Royalties Payable due to Related Parties |
Trading Debt Securities |
|||||||
|
Balance at January 1, 2025 |
$ |
|
$ |
|
||||
|
Change in fair value |
|
|
||||||
|
Balance at March 31, 2025 |
|
|
||||||
|
Purchased |
|
|
||||||
|
Change in fair value |
|
|
||||||
|
Balance at June 30, 2025 |
|
|
||||||
|
Change in fair value |
(
|
) |
|
|||||
|
Balance at September 30, 2025 |
$ |
|
$ |
|
||||
The table below summarizes the change in fair value of royalties payable due to related parties and trading debt securities for the three and nine months ended September 30, 2024 (in thousands):
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
||||||||
|
Royalties Payable due to Related Parties |
Trading Debt Securities |
|||||||
|
Balance at January 1, 2024 |
$ |
|
$ |
|
||||
|
Change in fair value |
|
|
||||||
|
Balance at March 31, 2024 |
|
|
||||||
|
Change in fair value |
|
|
||||||
|
Balance at June 30, 2024 |
|
|
||||||
|
Change in fair value |
|
|
||||||
|
Balance at September 30, 2024 |
$ |
|
$ |
|
||||
Increases or decreases in the fair value of royalties payable due to related parties or trading debt securities can result from updates to assumptions. Judgment is used in determining these assumptions as of the initial valuation date and at each subsequent reporting period. Changes or updates to assumptions could have a material impact on the reported fair value, the change in fair value, and the results of operations in any given period.
Accounts Receivable and Allowances for Credit Losses
Accounts receivable consists of trade receivables recorded at invoiced amounts. Accounts receivable is presented net of any discounts and allowance for credit losses, is unsecured and does not bear interest. Accounts receivable is evaluated for collectability based on historical credit loss experience, adjusted for asset-specific risk characteristics, current economic conditions, and reasonable forecasts, including the probability of future collection and estimated loss rates based on aging schedules. Accounts receivable is assessed for collectability based on portfolio segments: Hospitals - United States, Hospitals - Europe, and Distributors. The determination of portfolio segments is based on the customers’ industry and geographical location.
Changes in the estimated collectability of accounts receivable are recorded in the condensed consolidated statements of operations in the period in which the estimate is revised. Accounts receivable are written off as uncollectible after all means of collection are exhausted. Any subsequent recoveries are credited to the allowance for credit losses. As of September 30, 2025 and December 31, 2024 , the allowance for credit losses related to accounts receivable was immaterial.
Inventories
Inventories are stated at the lower of cost (determined by the first -in, first -out method) or net realizable value. Cost includes materials, labor, and manufacturing overhead related to the purchase and production of inventories. The Company reduces the carrying value of inventories for those items that are potentially in excess, obsolete or slow-moving based on changes in customer demand, technological developments or other economic factors.
Property and Equipment
Property and equipment are recorded at cost, less accumulated depreciation. Property and equipment are depreciated on a straight-line basis over their estimated useful lives as follows:
|
Machinery and equipment |
||||
|
Computer hardware and software |
||||
|
LockeT animation video |
||||
|
VIVO DEMO/Clinical Systems |
The Company periodically reviews the residual values and estimated useful lives of each class of its property and equipment for ongoing reasonableness, considering the long-term views of their intended use and the level of planned improvements to maintain and enhance those assets. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from their respective account balances, and any resulting gain or loss is recognized in the Company’s condensed consolidated statements of operations. The cost of repairs and maintenance is expensed as incurred, whereas significant renewals and betterments are capitalized.
Impairment of Long-lived Assets
In accordance with ASC Topic 360, Impairment and Disposals of Long-lived Assets , the Company periodically reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that such assets might be impaired and the carrying value of the long-lived assets may not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and the expected undiscounted future cash flows attributable to the asset are less than the carrying amount of the asset, an impairment loss equal to the excess of the assets carrying value over its fair value is recorded in the Company’s condensed consolidated statements of operations at that date. The Company has analyzed a variety of factors impacting its business to determine if a circumstance could trigger an impairment loss, and, at this time and based on the information presently known, does not believe it is more likely than that an impairment loss has been incurred.
Royalties Payable Due to Related Parties
The Company is obligated to pay royalties related to the sales of LockeT and AMIGO System under various royalty agreements executed by Old Catheter. The Company recognizes a liability for royalty fees incurred and payable based on actual sales of products under current portion of royalties payable due to related parties in the condensed consolidated balance sheets. The Company recognizes a liability for future, estimated royalty payments at fair value under current portion of royalties payable due to related parties in the condensed consolidated balance sheets if it is payable within the next 12 months and under royalties payable due to related parties in the condensed consolidated balance sheets if it is payable 12 months after the balance sheet date. The royalties payable due to related parties is remeasured at each reporting period. Changes in fair value of royalties payable due to related parties are recorded on the condensed consolidated statements of operations in the period in which they occur. See Note 8, Royalties Payable for additional information.
Asset Acquisitions and In-process Research and Development
The Company accounts for acquisitions of assets or a group of assets that do not meet the definition of a business as asset acquisitions based on the cost to acquire the asset or group of assets, which includes certain transaction costs. In an asset acquisition, the cost to acquire is allocated to the identifiable assets acquired and liabilities assumed based on their relative fair values as of the acquisition date. No goodwill is recorded in an asset acquisition.
Assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development (“IPR&D”) in the condensed consolidated balance sheets. Acquired IPR&D that has no alternative future use as of the acquisition date is recognized as acquired-in-process research and development expense in the condensed consolidated statements of operations as of the acquisition date.
Contingent consideration in asset acquisitions that is not accounted for as a derivative is measured and recognized when payment becomes probable and reasonably estimable. Subsequent changes in the accrued amount of contingent consideration are measured and recognized at the end of each reporting period and upon settlement as an adjustment to the cost basis of the acquired asset or group of assets, or, if related to IPR&D with no alternative future use, recognized as expense. Contingent consideration that is in the form of a sales or usage-based royalty payment is recognized as an expense as incurred.
Debt Securities
Debt securities consist of the QHSLab Notes, which were received as partial consideration for the PIPE Units and Series B Convertible Preferred Stock issued by the Company under the
May 2025
PIPE Financing (see Note
11,
Equity Offerings for further details). One QHSLab Note was originally issued on
August 10, 2021
with a principal amount of $
Under ASC Topic 320, Investments: Debt Securities, debt securities are classified into one of three categories upon acquisition: held-to-maturity, available-for-sale or trading. Debt securities that the Company has both the positive intent and ability to hold to maturity are classified as held to maturity. Debt securities that are bought and held principally for the purpose of selling them in the near term are classified as trading. All other debt securities are classified as available-for-sale. As the Company acquired the QHSLab Notes with the intent of selling them, the QHSLab Notes are classified as trading debt securities.
Trading debt securities are initially and subsequently measured at fair value in the condensed consolidated balance sheets, with unrealized holding gains and losses included in change in fair value of trading debt securities in the condensed consolidated statements of operations. The QHSLab Notes were valued at $
Variable Interest Entity
A variable interest entity ("VIE") is a legal entity that does not have sufficient equity at risk to finance its activities without additional subordinated financial support or is structured such that equity investors lack the ability to make significant decisions relating to the entity’s operations through voting rights or do not substantively participate in the gains or losses of the entity. The primary beneficiary has both the power to direct the activities of the VIE that most significantly impact the entity’s economic performance and the obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE.
The Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC Topic 810, Consolidation ("ASC 810" ). These evaluations can be complex and judgmental, involving the use of estimates and assumptions based on available information among other factors. Based on these evaluations, if the Company determines it is the primary beneficiary of a VIE, the Company consolidates the accounts of that VIE. The equity owned by other stockholders is presented, as applicable, as non-controlling interests in the accompanying condensed consolidated balance sheets, statements of operations, and statements of stockholders’ equity.
If a reconsideration event occurs under ASC 810, the Company performs an assessment to determine whether the entity continues to be a VIE, whether the Company still contains a variable interest in the VIE, and whether the Company continues to be or has become the primary beneficiary of the VIE.
Cardionomix
Cardionomix is a legal entity that was solely created to hold the assets of and to clinically develop and commercialize the CPNS System. The Company holds
As of
September 30, 2025
, Cardionomix only had a note payable with a carrying value of $
The Company provided financial support to Cardionomix, including the payment of direct transactions costs totaling $
The minority equity interest holders are presented as non-controlling interests in the accompanying condensed consolidated balance sheets, statements of operations, and statements of stockholders’ equity.
KardioNav
KardioNav is a legal entity that was solely created to hold the assets of and to clinically develop and commercialize certain intellectual property related to new cardiac technology. The Company holds
As of
September 30, 2025
, KardioNav's only assets or liabilities relate to prepaid expenses and other current assets of $
The minority equity interest holders are presented as non-controlling interests in the accompanying condensed consolidated balance sheets, statements of operations, and statements of stockholders’ equity.
Distinguishing Liabilities from Equity
The Company evaluates equity or liability classification for freestanding financial instruments, including convertible preferred stock, warrants, and options, pursuant to the guidance under ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480” ). The Company classifies as liabilities all freestanding financial instruments that are (i) mandatorily redeemable, (ii) represent an obligation to repurchase the Company’s equity shares by transferring assets, or (iii) represent an unconditional obligation (or conditional obligation if the financial instrument is not an outstanding share) to issue a variable number of shares predominantly based on a fixed monetary amount, variations in something other than the fair value of the Company’s equity shares, or variations inversely related to changes in fair value of the Company’s equity shares.
If a freestanding financial instrument does not represent an outstanding equity share and does not meet liability classification under ASC 480, the Company then assesses whether the freestanding financial instrument is indexed to its own stock and meets equity classification pursuant to ASC 815 - 40, Derivatives and Hedging (“ASC 815” ). The Company further assesses whether the freestanding financial instruments should be classified as temporary equity. Freestanding financial instruments that are redeemable for cash or other assets at a fixed or determinable date, at the option of the holder, or upon the occurrence of an event are classified in temporary equity in accordance with ASC 480. Otherwise, the freestanding financial instruments are classified in permanent equity.
See Note 11, Equity Offerings and Note 12, Preferred Stock for additional information on the freestanding financial instruments assessed under ASC 480 and ASC 815 - 40 for equity or liability classification.
Revenue Recognition
In accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606” ), the Company accounts for contracts with customers when there is a legally enforceable contract, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. Revenue is measured as the amount of consideration expected to be received in exchange for transferring promised goods or services. The amount of consideration to be received and revenue recognized may vary due to discounts. A performance obligation is a promise in a contract to transfer a distinct good or service. If there are multiple performance obligations in the customer contract, the Company allocates the transaction price in the contract to each performance obligation based on the relative standalone selling price. The Company does not adjust revenue for the effects of a significant financing component for contracts if the period between the transfer of control and corresponding payment is expected to be one year or less. Revenue is recognized when performance obligations in the customer contract are satisfied. This generally occurs when the customer obtains control of a promised good at a point in time or when a customer receives a promised service over time.
Pursuant to ASC 606, the Company applies the following five steps to each customer contract:
Step 1: Identify the contract with the customer
Step 2: Identify the performance obligations in the contract
Step 3: Determine the transaction price
Step 4: Allocate the transaction price to the performance obligations in the contract
Step 5: Recognize revenue when the Company satisfies a performance obligation
The Company has elected as a practical expedient to expense as incurred any costs incurred to obtain a contract as the related amortization period would be one year or less.
VIVO System
The VIVO System offers 3D cardiac mapping to help localize the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to electrophysiology studies. Customers are provided with VIVO Positioning Patch Sets, which are custom patches, that are used in conjunction with the VIVO System. The VIVO Positioning Patch Sets are integral to the functionality of the VIVO System. The VIVO System, including the VIVO Positioning Patch Sets, represents the Company’s primary performance obligation. The Company recognizes revenue when physical possession and control of the VIVO System is transferred to the customer upon delivery. The Company also offers customers software upgrades for the VIVO System, which may be purchased and paid in advance at contract inception. Software upgrades represent stand-ready services, whereby the Company promises to provide software upgrades to the customer when and as upgrades are available. Software upgrade services may be offered for initial contract terms of one to multiple years. Customers have the option to renew software upgrades services at the end of each term. The software upgrade services represent the Company's second performance obligation, which is recognized evenly over time over the contract term.
The Company invoices the customer for the VIVO System and related software upgrades after physical possession and control of the VIVO System has been transferred to the customer. Subsequent renewals for software upgrades are invoiced at inception of the renewed term. The timing of payment for the corresponding invoices depends on the credit terms identified in each customer contract. There were
LockeT
LockeT was launched by the Company in February 2023 and is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. The LockeT device represents a performance obligation in the customer contract. The Company recognizes revenue when it transfers control of the LockeT device to the customer, which happens when the Company delivers the product to the customer.
Disaggregation of Revenue
The following table summarizes disaggregated product sales by geographic area (in thousands):
|
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Product sales |
||||||||||||||||
|
US |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Europe |
|
|
|
|
||||||||||||
|
Total product sales |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
Shipping and Handling Costs
Shipping and handling costs charged to customers are included in net product sales, while all other shipping and handling costs are included in selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.
Advertising and Marketing
Advertising costs are expensed as incurred and included in selling, general and administrative expenses in the unaudited condensed consolidated statements of operations. Advertising costs were $
Patents
The Company expenses patent costs, including related legal costs, as incurred and records such costs as selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.
Research and Development
Major components of research and development costs include consulting, research grants, supplies and clinical trial expenses. Research and development expenses are charged to operations in the period incurred.
Stock-based Compensation
The Company recognizes stock-based compensation expense associated with stock options, restricted stock awards (“RSAs”) and restricted stock units (“RSUs”) issued to employees, members of the Company’s board of directors and consultants in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718” ). The Company evaluates whether stock-based awards should be classified and accounted for as liability or equity awards on the date of grant. Furthermore, the Company measures all stock-based awards granted based on their fair value on the date of grant. Stock options are measured at fair value using the Black-Scholes option pricing valuation model (the “Black-Scholes model”), which incorporates various assumptions, including expected term, volatility and risk-free interest rate. The expected term of the options is the estimated period of time until exercise and was determined using the SEC’s safe harbor rules, using an average of vesting and contractual terms, as the Company did not have sufficient historical experience of similar awards. Expected stock price volatility is based on historical volatilities of certain “guideline” companies, as the Company does not have sufficient historical stock price data. The risk-free interest rate is based on the implied yield available on U.S. Treasury zero -coupon issues with an equivalent term. Stock-based compensation expense for all stock-based awards is recognized over the requisite service period, which is generally the vesting period of the respective stock award. Stock-based compensation expense for stock-based awards with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not probable or is not met, no stock-based compensation expense is recognized, and any previously recognized compensation expense is reversed. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences reverse. Any resulting net deferred tax assets are evaluated for recoverability and, accordingly, a valuation allowance is provided when it is more likely than not that all or some portion of the deferred tax asset will not be realized.
The Company accounts for uncertainty in income taxes using a two -step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining whether it is more likely than not that the position will be sustained on an audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. An uncertain tax position is considered effectively settled on completion of an examination by a taxing authority if certain other conditions are satisfied. Should the Company incur interest and penalties relating to tax uncertainties, such amounts would be classified as a component of interest expense and other expense, respectively.
On July 4, 2025, the One Big Beautiful Bill Act, was signed into law. The legislation did not have a material impact on our income tax expense for the fiscal quarter ended September 30, 2025, and we do not expect it to materially change our effective income tax rate for 2025.
Basic and Diluted Net Loss per Share
Earnings per share attributable to Catheter Precision, Inc. common stockholders is calculated using the
two
-class method, which is an earnings allocation formula that determines earnings per share for the holders of the Company’s common shares and participating securities. The Company’s Series A Convertible Preferred Stock, of which
Diluted net loss per share is computed using the more dilutive of (a) the two -class method or (b) the if-converted method and treasury stock method, as applicable. In periods in which the Company reports a net loss attributable to Catheter Precision, Inc. common stockholders, diluted net loss per share attributable to Catheter Precision, Inc. common stockholders is the same as basic net loss per share attributable to Catheter Precision, Inc. common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is equivalent to basic net loss per share for the periods presented herein because common stock equivalent shares from outstanding warrants, stock options, non-vested restricted stock awards, Series X Convertible Preferred Stock and Series B Convertible Preferred Stock were anti-dilutive (see Note 10, Net Loss per Share).
Net loss attributable to Catheter Precision, Inc. common stockholders consists of net income or loss attributable to Catheter Precision, Inc., as adjusted for actual and deemed dividends declared, if applicable.
Recently Announced Accounting Pronouncements
In December 2023, the FASB issued ASU 2023 - 09, Income Taxes (Topic 740 ): Improvements to Income Tax Disclosures , which requires public entities to disclose consistent categories and greater disaggregation of information in the rate reconciliation and for income taxes paid. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is required to adopt this standard prospectively in fiscal year 2025 for the annual reporting period ending December 31, 2025. The Company does not believe the impact of the new guidance and related codification improvements will have a material impact on its financial position, results of operations and cash flows.
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 ("ASU 2024 - 03" ). In January 2025, the FASB issued ASU 2025 - 01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220 - 40 ), Clarifying the Effective Date ("ASU 2025 - 01" ). ASU 2024 - 03 requires the disaggregation of certain costs and expenses in the notes to the financial statements to provide enhanced transparency into the expense captions presented on the face of the income statement. ASU 2024 - 03, as clarified by ASU 2025 - 01, is effective for the Company’s Annual Report on Form 10 -K for the fiscal year ending December 31, 2027 and for interim periods beginning in 2028. The guidance may be applied on a prospective or retrospective basis and early adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2024 - 03 on its condensed consolidated financial statements.
Note 3. Inventories
Inventories consisted of the following (in thousands):
| September 30, | December 31, | |||||||
|
2025 |
2024 |
|||||||
|
Raw materials |
$ |
|
$ |
|
||||
|
Finished goods |
|
|
||||||
|
Inventories |
$ |
|
$ |
|
||||
There were
Note 4. Property and Equipment
Property and equipment, net consisted of the following (in thousands):
| September 30, | December 31, | |||||||
|
2025 |
2024 |
|||||||
|
Machinery and equipment |
$ |
|
$ |
|
||||
|
Computer hardware and software |
|
|
||||||
|
LockeT animation video |
|
|
||||||
|
VIVO DEMO/Clinical Systems |
|
|
||||||
|
Property and equipment, gross |
|
|
||||||
|
Accumulated depreciation |
(
|
) |
(
|
) | ||||
|
Property and equipment, net |
$ |
|
$ |
|
||||
Depreciation expense was $
Note 5. Intangible Assets
The following table summarizes the Company’s intangible assets as of September 30, 2025 (in thousands):
|
Estimated |
||||||||||||||||
|
Useful Life |
Gross Carrying |
Accumulated |
Net Carrying |
|||||||||||||
|
( Years) |
Amount |
Amortization |
Value |
|||||||||||||
|
Developed technology ‐ VIVO |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||
|
Developed technology ‐ LockeT |
|
|
(
|
) |
|
|||||||||||
|
Customer relationships |
|
|
(
|
) |
|
|||||||||||
|
Trademarks/trade names ‐ VIVO |
|
|
(
|
) |
|
|||||||||||
|
Trademarks/trade names ‐ LockeT |
|
|
(
|
) |
|
|||||||||||
| $ |
|
$ |
(
|
) | $ |
|
||||||||||
The following table summarizes the Company’s intangible assets as of December 31, 2024 (in thousands):
|
Estimated |
||||||||||||||||
|
Useful Life |
Gross Carrying |
Accumulated |
Net Carrying |
|||||||||||||
|
( Years) |
Amount |
Amortization |
Value |
|||||||||||||
|
Developed technology ‐ VIVO |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||
|
Developed technology ‐ LockeT |
|
|
(
|
) |
|
|||||||||||
|
Customer relationships |
|
|
(
|
) |
|
|||||||||||
|
Trademarks/trade names ‐ VIVO |
|
|
(
|
) |
|
|||||||||||
|
Trademarks/trade names ‐ LockeT |
|
|
(
|
) |
|
|||||||||||
| $ |
|
$ |
(
|
) | $ |
|
||||||||||
The estimated future amortization expense for the next five years and thereafter is as follows (in thousands):
|
Future |
||||
|
Amortization |
||||
|
Years ending December 31, |
Expense |
|||
|
Remainder of 2025 |
$ |
|
||
|
2026 |
|
|||
|
2027 |
|
|||
|
2028 |
|
|||
|
2029 |
|
|||
|
Thereafter |
|
|||
|
Total |
$ |
|
||
The Company uses the straight-line method to determine amortization expense for its definite lived intangible assets. Amortization expense, included within selling, general and administrative expenses in the condensed consolidated statements of operations, for the Company's intangible assets was $
Note 6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| September 30, | December 31, | |||||||
|
2025 |
2024 |
|||||||
|
Legal expenses |
$ |
|
$ |
|
||||
|
Offering costs |
|
|
||||||
|
Compensation and related benefits |
|
|
||||||
|
Other accrued expenses |
|
|
||||||
|
Accrued expenses |
$ |
|
$ |
|
||||
Note 7. Notes Payable
Note Payable - Director and Officer Liability Insurance
The Company purchased director and officer liability insurance coverage on
October 16, 2023
for $
The Company purchased director and officer liability insurance coverage on
September 26, 2024
for $
Note Payable Issued for the Cardionomic Asset Acquisition
In connection with the asset acquisition of the CPNS System previously held by Cardionomic, on
May 5, 2025,
Cardionomix issued a promissory note with a face amount of $
The Note Payable was initially measured at its present value of $
Interest expense on this note was $
Future maturities for long-term debt as of September 30, 2025 were as follows (in thousands):
|
September 30, |
||||
|
2025 |
||||
|
2025 |
$ |
|
||
|
2026 |
|
|||
|
2027 |
|
|||
|
2028 |
|
|||
|
Total |
$ |
|
||
Promissory Notes (Collectively, the “Related Party Notes”)
On
May 30, 2024,
David A. Jenkins loaned $
On
June 25, 2024,
an entity controlled by Mr. Jenkins loaned $
On
July 1, 2024
and
July 18, 2024,
the Company entered into
two
short-term promissory notes with an affiliate of Mr. Jenkins, wherein the affiliate loaned $
On
July 25, 2024,
the Company entered into a short-term promissory note with a Trust, of which Mr. Jenkins’ adult daughter is the trustee, wherein the Trust loaned $
All of these short-term promissory notes (the “Related Party Notes”) had a maturity date of
August 30, 2024
and interest of
On
August 23, 2024,
the Company entered into the
first
amendment of the Related Party Notes, which extended the maturity date to
January 31, 2026
and increased the interest rate to
The Related Party Notes, including all principal and interest, accelerate and become immediately due and payable upon the occurrence of certain customary events of default, including failure to pay amounts owed when due, material breach of the Company’s representations or warranties (unless waived by the holders of the Related Party Notes or cured within 10 days following notice), certain events involving the discontinuation of the Company’s business and/or certain types of proceedings involving insolvency, bankruptcy, receivership and the like.
Interest expense on the Related Party Notes was
$
The Related Party Notes and related accrued interest totaled $
Notes Payable Issued by KardioNav
On
July 11, 2025,
two
short-term promissory notes with a face amount of $
The Notes Payable, including all principal and interest, accelerate and become immediately due and payable upon the occurrence of certain customary events of default, including failure to pay amounts owed when due, material breach of the Company’s representations or warranties (unless waived by the holders or cured within 10 days following notice), certain events involving the discontinuation of the Company’s business and/or certain types of proceedings involving insolvency, bankruptcy, receivership and the like.
Interest expense on this note was $
Note 8. Royalties Payable
LockeT Royalty
On
January 9, 2023,
prior to the consummation of the Merger, Old Catheter entered in an agreement with its Convertible Promissory Noteholders (“Noteholders”), which substantially consisted of amounts due to David A. Jenkins, previously Old Catheter's Chairman of the Board of Directors prior to the Merger, and, currently, the Company’s Executive Chairman of the Board of Directors and Chief Executive Officer, to forgive all accrued interest and future interest expense in exchange for a future royalty right. Under these agreements, the Company is obligated to pay the Noteholders a total royalty equal to
An additional royalty will be paid to the inventor of the LockeT device as detailed in the Royalty Agreement. In exchange for the assignment and all rights to LockeT and starting with the year ending
December 31, 2022,
the Company will initially pay a
During
2006
and
2007,
Old Catheter entered into
|
Until Royalty Payment |
||||
|
Royalty Percentage |
Reaches a Total of |
|||
|
|
$ |
|
||
|
|
$ |
|
||
|
|
In perpetuity |
|||
The Company is
not
actively marketing and selling the AMIGO System, such that there was
Note 9. Leases
The Company determines if an arrangement contains a lease at contract inception based on its ability to control a physically distinct asset in exchange for consideration. If the arrangement contains a lease, the Company then determines the classification of the lease as either operating or finance. For the nine months ended September 30, 2025 , and the year ended December 31, 2024 , the Company only had operating leases.
For operating leases, right-of-use (“ROU”) assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The present values of future lease payments are discounted using the interest rate implicit in the lease if it is readily determinable. As most leases do not provide an implicit rate, the Company applies an incremental borrowing rate based on the information available at commencement date to determine the present value of future lease payments over the lease term. The Company benchmarked itself against other companies with similar credit ratings and of comparable quality to derive an incremental borrowing rate. Lease expense is recognized on a straight-line basis over the lease term in the condensed consolidated statements of operations.
The Company elected to utilize the short-term lease exemption to exclude recognition of ROU assets and lease liabilities from the condensed consolidated balance sheet for leases with an initial term of 12 months or less, with payments instead being expensed on a straight-line basis over the lease term. If a lease includes options to extend the lease term, the Company does not assume the option will be exercised in its initial lease term assessment unless there is reasonable certainty that the Company will renew based on an assessment of economic factors present as of the lease commencement date. The Company monitors its plans to renew its material lease each reporting period.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components include costs that do not provide a right-to-use a leased asset but instead provide a service such as maintenance costs. The Company has elected to account for the lease and non-lease components together as a single component for all classes of underlying assets. Variable costs associated with the lease, such as maintenance and utilities, are not included in the measurement of ROU assets and liabilities. Variable costs are expensed when the events determining the amount of variable consideration to be paid have occurred.
South Carolina Office Lease Agreement
On
September 27, 2022,
Old Catheter entered into a lease agreement for office space located in Fort Mill, South Carolina. The space is used for office and general use. The lease term began on
October 1, 2022
for
As of September 30, 2025 , the Company does not intend to exercise the second extension option and the second option is therefore excluded from operating right-of-use assets and operating lease liabilities in the condensed consolidated balance sheet as of September 30, 2025 .
New Jersey Office Lease Agreement
On
December 7, 2022,
Old Catheter entered into a lease agreement for office space located in Augusta, New Jersey. The space is used for office and general use. The lease term began on
January 1, 2023
for
On July 8 2025, the Company entered into a second lease extension agreement to extend the lease for an additional 24 -month period through the end of December 31, 2027. Accordingly, the Company remeasured the lease liability on the basis of the revised lease payments and lease term, such that the extension option of 24 months has been included in operating right-of-use-assets and operating lease liabilities in the condensed consolidated balance sheet as of September 30, 2025 .
Park City Office Lease Agreement
On
March 19, 2023,
the Company entered into a lease agreement for office space located in Park City, Utah. The space is used for office and general use. The lease term began on
May 1, 2023
for
The following tables present supplemental condensed consolidated balance sheet information related to operating leases for the three and nine months ended September 30, 2025 and 2024 (in thousands):
|
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||||||
|
September 30, |
September 30, |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Operating lease expense |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
|
Cash paid for leases |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
| September 30, | December 31, | |||||
|
2025 |
2024 |
|||||
|
Weighted average remaining lease term (in years) - operating leases |
|
|
||||
|
Weighted average discount rate - operating leases |
|
% |
|
% | ||
Future minimum lease payments for all lease obligations for the following five fiscal years and thereafter are as follows (in thousands):
|
Years ending December 31: |
Operating Leases |
|||
|
Remainder of 2025 |
$ |
|
||
|
2026 |
|
|||
|
2027 |
|
|||
|
2028 |
|
|||
|
Total minimum lease payments |
|
|||
|
Less effects of discounting |
(
|
) | ||
|
Present value of future minimum lease payments |
$ |
|
||
Operating lease right-of-use assets and lease liabilities were recorded in the condensed consolidated balance sheets as follows (in thousands):
|
September 30, |
December 31, |
|||||||
|
2025 |
2024 |
|||||||
|
Operating lease right-of-use assets, net |
$ |
|
$ |
|
||||
|
Current portion of operating lease liabilities |
$ |
|
$ |
|
||||
|
Operating lease liabilities |
|
|
||||||
|
Total operating lease liabilities |
$ |
|
$ |
|
||||
Note 10. Net Loss per Share
The Company’s outstanding Series
X
Convertible Preferred Stock, Series B Convertible Preferred Stock, and warrants to purchase common stock have participation rights to any dividends that
may
be declared in the future, such that they are participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss,
no
loss is allocated to the participating securities since the holders have
no
contractual obligation to share in the losses of the Company.
All common share and per-share amounts for all periods presented reflect the Company’s
1
-for-
As a result of the net loss attributable to Catheter Precision, Inc.'s common stockholders for all periods presented herein, the following common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the three and nine months ended September 30, 2025 and 2024 because including them would have been antidilutive:
|
September 30, |
||||
|
2025 |
2024 |
|||
|
Warrants for common stock |
|
|
||
|
Employee stock options |
|
|
||
|
Series B Convertible Preferred Stock |
|
|
||
|
Series X Convertible Preferred Stock |
|
|
||
|
Restricted stock awards |
|
|
||
|
Total common stock equivalents |
|
|
||
The weighted-average number of common shares outstanding as of
September 30, 2025
includes
Note 11. Equity Offerings
September 2024 Public Offering
On
August 30, 2024,
the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc. as representative (“Ladenburg”) of the underwriters named in the Underwriting Agreement (the “Underwriters”). Pursuant to the Underwriting Agreement, the Company completed a public offering of its securities on
September 3, 2024 (
the
“September 2024
Public Offering”) and sold an aggregate of (i)
Each Common Stock Unit consisted of (i)
Each Pre-Funded Warrant Unit consisted of (i)
Pursuant to the Underwriting Agreement, the Company granted Ladenburg a
Furthermore, at the closing date, the Company agreed to deliver to Ladenburg warrants to purchase an aggregate number of shares of common stock equal to
Each Series H Warrant, Series I Warrant, Series J Warrant (collectively, the “Series Warrants”), and Pre-Funded Warrant was immediately exercisable. The exercise price of the outstanding Series Warrants and Pre-Funded Warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. Subject to limited exceptions, a holder of the Series Warrants will
not
have the right to exercise any portion of its Series Warrants if the holder (together with such holder’s affiliates) would beneficially own a number of shares of common stock in excess of
The Representative Warrants became exercisable
months after the effective date of the Registration Statement filed by the Company on
August 29, 2024.
The Representative Warrants further have a Beneficial Ownership Limitation of
The Company assessed the Series Warrants, Pre-Funded Warrants, and Representative Warrants issued in connection with the September 2024 Public Offering (collectively, the “September 2024 Warrants”) and determined that they do not require liability classification pursuant to ASC 480. Furthermore, the September 2024 Warrants do not have any net cash settlement provisions that would preclude equity classification under ASC 815 - 40. Accordingly, the September 2024 Warrants were recorded to additional paid-in capital in the condensed consolidated balance sheets.
All
2024 Warrant Inducement Offer
On
October 25, 2024,
the Company executed the
2024
Warrant Inducement Offer with certain holders of the Company’s existing warrants (Series E, Series F, Series G, Series H and Series I Warrants, collectively the
“2024
Existing Warrants”). Pursuant to the terms of the
2024
Warrant Inducement Offer, the Company agreed to lower the exercise price per share of common stock for all holders of the
2024
Existing Warrants, including those that did
not
participate in the
2024
Warrant Inducement Offer. The
2024
Existing Warrants had exercise prices ranging from $
In consideration for the immediate exercise of the
2024
Existing Warrants for cash, the Company issued unregistered new Series K common stock purchase warrants (“Series K Warrants”) to purchase up to
In connection with the closing, the Company issued Placement Agent Warrants to the Placement Agent to purchase up to
As a result of the
2024
Warrant Inducement Offer, the Company recorded a deemed dividend for the modification of the
2024
Existing Warrants and issuance of the Series K Warrants of $
Pursuant to the terms of the 2024 Warrant Inducement Offer, in the event that the exercise of the 2024 Existing Warrants would cause a holder to exceed the beneficial ownership limitations included therein, the Company would issue the number of shares of common stock that would not cause a holder to exceed such beneficial ownership limitations and hold the remaining balance of shares of common stock in abeyance (the "Abeyance Shares"). The Abeyance Shares were evidenced through the holder’s existing warrants, which are deemed to be prepaid. The Abeyance Shares were held by the Company until the holder sent notice that the remaining balance of shares of common stock could be issued without surpassing the beneficial ownership limitations.
During the
nine
months ended
September 30, 2025
, the Company released and issued the remaining balance of
In the event of certain transactions resulting in a change in control, at the option of the holder, the Company shall repurchase the Series L Warrants for an amount of cash equal to the Black Scholes Value of the unexercised portion of the Series L Warrants. However, if the change of control is not within the Company’s control, then the holders shall receive the same type of consideration offered to the Company’s common stockholders at the Black Scholes Value of the unexercised portion of the Series L Warrant. If the Company’s common stockholders can choose the type of consideration (i.e., cash, stock, or other assets) to be received, then the Holders shall have the same choice. If the Company’s common stockholders do not receive any consideration, they are deemed to receive common stock of the successor entity.
In the event of certain restructuring or disposal events, then upon the subsequent exercise of the Series L Warrants, for each share of common stock that would have been issuable upon exercise immediately prior to the event, the holders shall receive the number of shares of common stock of the successor entity and any alternate consideration given to common stockholders. The exercise price shall be adjusted to apply to such alternate consideration based on the amount of alternate consideration issuable for
Subject to limited exceptions, the holders of Series L Warrants, will
not
have the right to exercise any portion of the warrant if the holder (together with such holder’s affiliates) would beneficially own a number of shares of common stock in excess of
The Company assessed the Series L Warrants and Placement Agent Warrants issued in connection with the May 2025 PIPE Financing and determined that they do not require liability classification pursuant to ASC 480. Furthermore, the Series L Warrants and Placement Agent Warrants do not have any net cash settlement provisions that would preclude equity classification under ASC 815 - 40. Accordingly, the Series L Warrants and Placement Agent Warrants were recorded to additional paid-in capital in the condensed consolidated balance sheets.
See Note 12, Preferred Stock for additional information on the Series B Convertible Preferred Stock issued by the Company in connection with the May 2025 PIPE Financing.
In addition, the Company entered into a registration rights agreement with the investors requiring the Company to register for resale the shares of common stock issuable upon the conversion of the Series B Convertible Preferred Stock and Series L Warrants. Failure to timely maintain the registration shall lead to an obligation to pay to the investors cash liquidated damages equal to
On May 21, 2025, the Company filed the registration statement on Form S- 3 for the resale of shares of common stock issuable upon the conversion of the Series B Convertible Preferred Stock and Series L Warrants, and it was declared effective on May 30, 2025. It is not probable that the Company will be obligated to make payments under the registration rights agreement as of September 30, 2025 .
The Company has no obligation to sell, and Ladenburg is not obligated to buy or sell, any of the Shares under the ATM Agreement and may at any time suspend offers under the ATM Agreement. The ATM Agreement will terminate upon the earlier of (i) the issuance and sale of all of the shares through Ladenburg on the terms and subject to the conditions set forth in the ATM Agreement or (ii) termination of the ATM Agreement as otherwise permitted thereby. The ATM Agreement may be terminated at any time by either party upon five ( 5 ) business days’ prior notice, or by Ladenburg at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.
Warrants
The following table presents the number of common stock warrants outstanding:
|
Warrants outstanding, December 31, 2024 |
|
|||
|
Issued |
|
|||
|
Exercised |
(
|
) | ||
|
Expired |
(
|
) | ||
|
Warrants outstanding, September 30, 2025 |
|
As of September 30, 2025 and December 31, 2024 , all warrants outstanding are recorded in additional paid-in capital in the condensed consolidated balance sheets. The following table presents the number and type of common stock purchase warrants outstanding, their exercise price, and expiration dates as of September 30, 2025 :
|
Warrants |
|||||||||
|
Warrant Type |
Outstanding |
Exercise Price |
Expiration Date |
||||||
|
August 2021 Pharos Banker Warrants |
|
$ |
|
|
|||||
|
February 2022 Series B Warrants |
|
$ |
|
|
|||||
|
July 2022 Series C Warrants |
|
$ |
|
|
|||||
|
September 2024 Series I Warrants |
|
$ |
|
|
|||||
|
September 2024 Series J Warrants |
|
$ |
|
|
|||||
|
September 2024 Representative Warrants |
|
$ |
|
|
|||||
|
October 2024 Series K Warrants |
|
$ |
|
|
|||||
|
October 2024 Placement Agent Warrants |
|
$ |
|
|
|||||
|
Series L Warrants |
|
$ |
|
|
|||||
|
Placement Agent Warrants May 2025 |
|
$ |
|
|
|||||
|
|
|||||||||
As of
September 30, 2025
, the warrants issued by the Company had a weighted average exercise price of $
|
Number of shares |
Exercise Price |
Expiration |
||||
|
|
$ |
|
|
|||
| $ |
|
|
||||
Note 12. Preferred Stock
Series X Convertible Preferred Stock
Pursuant to the Merger Agreement, all Old Catheter common stock shares issued and outstanding and Convertible Promissory Notes, representing an aggregate principal balance of $
Series
X
Convertible Preferred Stock has
no
voting rights prior to the conversion into common stock. While there are generally
no
voting rights of the Series
X
Convertible Preferred Stock, there are protective rights regarding the sales of the Company, change of control, etc. The remaining Series
X
Preferred Stock
may
convert into common stock only if the Company’s common stock has been delisted from the NYSE American or has been approved for initial listing on the NYSE American or another stock exchange, at a rate of
Other than dividends payable in shares of common stock, Holders of Series X Convertible Preferred Stock will be entitled to receive dividends on shares of Series X Convertible Preferred Stock equal, on an as-if-converted-to-common stock basis, and in the same form as dividends actually paid on shares of common stock.
Upon consummation of the Merger, each holder of Old Catheter Convertible Promissory Notes received, in exchange for discharge of the principal of their Notes, a number of shares of the Company's Series
X
Convertible Preferred Stock representing a potential right to convert into the Company's common stock in an amount equal to
one
common share for each $
As of
September 30, 2025
and
December 31, 2024,
the remaining
Series A Convertible Preferred Stock
On January 9, 2023, the Company entered into a Securities Purchase Agreement for a Private Placement with the Investor. Pursuant to the Securities Purchase Agreement, shares of Series A Convertible Preferred Stock were issued, the conversion of which was approved at the Stockholders’ Meeting. After the final conversion on July 23, 2024, the Company had no shares of Series A Convertible Preferred Stock outstanding.
The Series A Convertible Preferred Stock converted into common stock at the option of the holder at the Preferred Conversion Rate, subject to certain ownership limitations as described below. The conversion price was subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
Subject to limited exceptions, holders of shares of Series A Convertible Preferred Stock did
not
have the right to convert any portion of their Series A Convertible Preferred Stock if the holder, together with its affiliates, would beneficially own in excess of
Holders of Series A Convertible Preferred Stock were entitled to receive dividends on shares of Series A Convertible Preferred Stock equal, on an as-if-converted-to-common stock basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series A Convertible Preferred Stock did not have voting rights.
The Company also entered into a registration rights agreement with the purchasers requiring the Company to register for resale the shares of common stock issuable upon the conversion of the Series A Convertible Preferred Stock. Those shares of common stock were registered for resale on an effective registration statement on Form S- 1.
All of the Series A Convertible Preferred Stock were converted as follows:
|
Date of Conversion |
Series A Shares Converted |
Common Shares Issued |
|||
|
July 5, 2023 |
|
|
|||
|
July 24, 2023 |
|
|
|||
|
January 24, 2024 |
|
|
|||
|
July 1, 2024 |
|
|
|||
|
July 11, 2024 |
|
|
|||
|
July 22, 2024 |
|
|
|||
|
July 23, 2024 |
|
|
Each share of Series A Convertible Preferred Stock was convertible into approximately
As of September 30, 2025 and December 31, 2024, the Company had no shares of Series A Convertible Preferred Stock outstanding.
Series B Convertible Preferred Stock
On
May 12, 2025,
pursuant to the
May 2025
PIPE Financing, the Company issued
Subject to certain ownership limitations as described below, the Series B Convertible Preferred Stock was convertible into an aggregate of
The holders could convert all of the Series B Convertible Preferred Stock upon the date stockholder approval was obtained (“Stockholder Approval”). Stockholder Approval was obtained on
July 25, 2025.
Prior to Stockholder Approval, the Series B Convertible Stock could only be converted into up to
Holders of Series B Convertible Preferred Stock are entitled to receive dividends and distributions on shares of Series B Convertible Preferred Stock equal to, on an as-if-converted-to-common stock basis, and in the same form as dividends and distributions actually paid on shares of common stock.
The Series B Convertible Preferred Stockholders do not have a preference upon any liquidation, dissolution, or winding-up of the Company. In the event of certain restructuring or disposal events, then upon any subsequent conversion of the Series B Convertible Preferred Stock, for each convertible share that would have been issuable upon conversion immediately prior to the event, the holders shall receive the number of shares of common stock of the successor entity and any alternate consideration given to common stockholders. The conversion price shall be adjusted to apply to such alternate consideration based on the amount of alternate consideration issuable for one share of common stock. If holders of common stock are given any choice as to the securities, cash, or property received for alternate consideration, the holders of Series B Convertible Preferred Stock shall be given the same choice.
The Series B Convertible Preferred Stock includes certain contingent payment provisions that should be bifurcated and accounted for as a derivative under ASC 815. The estimated fair value of these embedded derivatives was deemed to be de minimis at issuance and at September 30, 2025 .
Except as otherwise required by law, the Series B Convertible Preferred Stock do not have any voting rights.
Series B Convertible Preferred Stock were converted as follows:
|
Date of Conversion |
Series B Shares Converted |
Common Shares Issued |
|||
|
June 11, 2025 |
|
|
As of
September 30, 2025
, the Company had
The
2018
Equity Incentive Plan (the
"2018
Plan") was replaced by the
2023
Equity Incentive Plan (the
"2023
Plan"), as described below. As of
September 30, 2025
, stock options outstanding under the
2018
Plan were eliminated following the reverse stock split at
1
-for-
2018 Employee Stock Purchase Plan
In
April 2024,
the Company formally terminated the
2018
Employee Stock Purchase Plan (the “ESPP”). Since inception through termination, the Company issued
2020 Inducement Equity Incentive Plan
The Company adopted the
2020
Inducement Equity Incentive Plan (the
“2020
Plan”) in
March 2020
and terminated it in
April 2024.
On adoption,
2023 Equity Incentive Plan
For the
nine
months ended
September 30, 2025
, the Committee approved
the grant of
|
For the Nine Months Ended |
||||||||
|
September 30, |
||||||||
|
2025 |
2024 |
|||||||
|
Risk-free interest rate |
|
% |
|
% | ||||
|
Volatility |
|
% |
|
% | ||||
|
Expected dividend yield |
|
% |
|
% | ||||
|
Expected life (in years) |
|
|
||||||
Options with Performance-Based Vesting Conditions
|
For the Nine Months Ended |
||||||||
|
September 30, |
||||||||
|
2025 |
2024 |
|||||||
|
Risk-free interest rate |
|
% |
|
|||||
|
Volatility |
|
% |
|
|||||
|
Expected dividend yield |
|
% | — | |||||
|
Expected life (in years) |
|
— | ||||||
The following is a summary of stock option activity for the 2023 Plan options for the nine months ended September 30, 2025 :
|
Weighted |
Weighted |
|||||||||||||||
|
Average |
Average |
Aggregate |
||||||||||||||
| Stock | Exercise | Remaining | Intrinsic Value | |||||||||||||
|
Options |
Price |
Life |
(in thousands) |
|||||||||||||
|
Outstanding at December 31, 2024 |
|
$ |
|
|
$ |
|
||||||||||
|
Options exercised |
|
|
— | — | ||||||||||||
|
Options granted |
|
|
— | — | ||||||||||||
|
Cancelled/forfeited |
(
|
) |
|
— | — | |||||||||||
|
Outstanding at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
|
Vested and expected to vest at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
|
Exercisable at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
The weighted-average grant-date fair value of the
2023
Plan options granted during the
nine
months ended
September 30, 2025
and
2024
was $
Non-Plan Options Issued
On
January 6, 2025,
the Board approved and issued a total of
The Non-Plan Options issued for the nine months ended September 30, 2025 and 2024 were valued using the Black-Scholes model based on the following assumptions on the date of issue:
|
For the Nine Months Ended |
||||||||
|
September 30, |
||||||||
|
2025 |
2024 |
|||||||
|
Risk-free interest rate |
|
% |
|
% | ||||
|
Volatility |
|
% |
|
% | ||||
|
Expected dividend yield |
|
% |
|
% | ||||
|
Expected life (in years) |
|
|
||||||
The following is a summary of stock option activity for the Non-Plan options for the nine months ended September 30, 2025 :
|
Weighted |
Weighted |
|||||||||||||||
|
Average |
Average |
Aggregate |
||||||||||||||
| Stock | Exercise | Remaining | Intrinsic Value | |||||||||||||
|
Options |
Price |
Life |
(in thousands) |
|||||||||||||
|
Outstanding at December 31, 2024 |
|
$ |
|
|
$ |
|
||||||||||
|
Options exercised |
|
|
— | — | ||||||||||||
|
Options granted |
|
|
— | — | ||||||||||||
|
Cancelled/forfeited |
(
|
) |
|
— | — | |||||||||||
|
Outstanding at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
|
Vested and expected to vest at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
|
Exercisable at September 30, 2025 |
|
$ |
|
|
$ |
|
||||||||||
The weighted-average grant-date fair value of the Non-Plan options granted during the
nine
months ended
September 30, 2025
and
2024
was $
Restricted Stock Awards
A summary of the restricted stock award activity for the nine months ended September 30, 2025 is presented below.
|
Weighted |
||||||||
|
Average |
||||||||
| Restricted | Grant Date | |||||||
|
Stock Awards |
Fair Value |
|||||||
|
Outstanding at December 31, 2024 |
|
$ |
|
|||||
|
Granted |
|
|
||||||
|
Vested |
(
|
) |
|
|||||
|
Cancelled/forfeited |
|
|
||||||
|
Outstanding at September 30, 2025 |
|
$ |
|
|||||
Stock-based compensation expense is recorded in selling, general and administrative expenses in the condensed consolidated statements of operations. Stock-based compensation expense for the
three
and
nine
months ended
September 30, 2025
was
$
Total unrecognized estimated stock-based compensation expense by award type and the remaining weighted average recognition period over which such expense is expected to be recognized at September 30, 2025 was as follows:
|
Unrecognized Expense (in thousands) |
Remaining Weighted Average Recognition Period |
|||||||
|
Stock options (Non-Plan Options) |
$ |
|
|
|||||
|
Stock options (2023 Plan Options) |
$ |
|
|
|||||
|
Restricted stock awards |
$ |
|
|
|||||
Note 14. Asset Acquisitions
On
January 24, 2025,
the Company acquired
On May 5, 2025, Cardionomix acquired certain assets from Cardionomic. The assets primarily related to Cardionomic’s CPNS System, which represents a novel technology for the late-stage treatment of acute decompensated heart failure.
The acquisition was accounted for as an asset acquisition consisting primarily of an IPR&D Asset (the CPNS System). The Company issued
See Note 7, Notes Payable for additional information on the Note Payable.
Note 15. Income Taxes
The provision for income taxes for interim periods is determined using an estimated annual effective tax rate. The effective tax rate may be subject to fluctuations during the year as new information is obtained, which may affect the assumptions used to estimate the annual effective tax rate, including factors such as valuation allowances against deferred tax assets, the recognition or de-recognition of tax benefits related to uncertain tax positions, if any, and changes in or the interpretation of tax laws in jurisdictions where the Company conducts business.
For the
three
and
nine
months ended
September 30, 2025
, the Company recorded federal income tax provision
of $
The Company has no open income tax audits with any taxing authority as of September 30, 2025 .
Note 16. Commitments and Contingencies
In the normal course of business, the Company is at times subject to pending and threatened legal actions. In management’s opinion, any potential loss resulting from the resolution of these matters will not have a material effect on the results of operations, financial position or cash flows of the Company.
As of September 30, 2025 , the Company had no outstanding litigation.
Note 17. Related Parties
Prior to the Merger, David A. Jenkins, the Company’s current Executive Chairman of the Board and Chief Executive Officer, and Old Catheter’s Chairman of the Board of Directors, and his affiliates held approximately $
In addition to the shares described above that were issued in connection with the Notes, Mr. Jenkins and his affiliates received
Mr. Jenkins’ daughter, the Company’s non-executive Chief Operating Officer, received options to purchase
On
May 1, 2024,
Marie-Claude Jacques, the Company’s then Chief Commercial Officer, received a non-plan option to purchase
During the year ended
December 31, 2024,
the Company entered into various short-term promissory notes with various related parties (the “Related Party Notes”). These Related Party Notes had a maturity date of
August 30, 2024
and interest rates of
The related parties and the amounts owed to each related party as of September 30, 2025 are summarized in the following table (in thousands):
|
Related Party |
Issuance Date |
Principal Amount |
Interest Accrued |
||||||
|
David Jenkins |
|
$ |
|
$ |
|
||||
|
FatBoy Capital |
|
$ |
|
$ |
|
||||
|
FatBoy Capital |
|
$ |
|
$ |
|
||||
|
FatBoy Capital |
|
$ |
|
$ |
|
||||
|
Jenkins Family Charitable Institute |
|
$ |
|
$ |
|
||||
|
David Jenkins |
|
$ |
|
$ |
|
||||
|
Lifestim, Inc. |
|
$ |
|
$ |
|
||||
On
September 3, 2024,
the Jenkins Family Charitable Institute also invested approximately $
On
October 28, 2024,
the Jenkins Family Charitable Institute exercised all
On
January 6, 2025,
Philip Anderson, the Company's Chief Financial Officer, received a non-plan option to purchase
In
February 2025,
Catheter formed its subsidiary Cardionomix. The capitalization structure of the newly formed entity included
On
June 20, 2025,
Catheter formed a new subsidiary, KardioNav. The capitalization structure of the newly formed entity include
Note 18. Subsequent Events
Increase in the Number of Authorized Shares of Common Stock
On
October 10, 2025,
at a special meeting of stockholders of the Company, the stockholders approved an amendment to the Amended and Restated Certificate of Incorporation of the Company, to effect an increase to the Company’s authorized common stock, from
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Special Note Regarding Forward Looking Statements
This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available. This section should be read in conjunction with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report. The statements contained in this Quarterly Report that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements can be identified by words such as “believe,” “anticipate,” “may,” “might,” “can,” “could,” “continue,” “depends,” “expect,” “expand,” “explore,” “forecast,” “intend,” “predict,” “plan,” “pursue,” “pursuit,” “rely,” “should,” “will,” “may,” “seek,” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. Statements concerning current conditions, operations or activities may also be forward-looking if they imply a continuation of current conditions, operations or activities. These statements include, but are not limited to, our descriptions of possible sources of financing that we are exploring, expectations regarding our operating businesses, including statements regarding our plans for conducting research and development with respect to, as well as securing appropriate FDA registrations and approvals of our products, including but not limited to those of our Cardionomix and KardioNav subsidiaries, as well as express and implied statements regarding our ability to continue as a going concern, sustain operations, and remain listed on the NYSE American, our expectations with respect to our timing and need for future financing, expectations regarding clinical studies of LockeT and the data they are expected to provide, including the impact of such data on marketing and FDA submissions, and our expectations with respect to our business strategy to become a leading medical device company in the field of cardiac electrophysiology, and to provide patients, hospitals, and physicians with novel technologies and solutions to improve the lives of patients with cardiac arrhythmias, and our aim to establish our products as integral tools used by cardiac electrophysiologists and their colleagues during ablation treatment of ventricular arrhythmias by reducing procedure time, patient complications and increasing procedural success, and possible sale of the QHS Notes. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements.
These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including, but not limited to, those described in Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2024, as well as those described below. To the extent that any risk factor set forth below is inconsistent with or expands upon a risk factor set forth in the 10‑K, the risk factor described below supersedes the prior disclosure. These risks include, but are not limited to, that: if we pursue a strategic transaction, such as a crypto treasury strategy, it may change the primary focus of our business, and our management team could be diverted from pursuing our present core business and from obtaining regulatory approval for our products in development; we will be unable to develop the assets acquired in by KardioNav and Cardionomix unless we are able to obtain additional financing in sufficient amounts to fund our current business, any future businesses we may enter into and to fund our products in development, which financing may not be available on acceptable terms or at all, and could require significant changes in our management and business focus, the results of anticipated trials may not turn out as we currently expect and future trials may not occur on the time tables we expect or may be more costly than anticipated, or may be abandoned due to lack of financing or changes in our business focus, we will be required to raise additional funds to finance our operations and continue as a going concern , and we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us or could require changes to governance or operations, and we may require additional funds sooner than our current expectations and we may be required to significantly dilute our existing stockholders in order to raise sufficient operating funds assuming that we are able to raise funds at all, which is uncertain; our stockholder equity is near the minimum level prescribed by the NYSE American and if we are unable to maintain minimum listing requirements, we are liable to be delisted from the NYSE American; our common stock may be subject to extreme market volatility and trading patterns and may experience rapid and substantial increases or decreases unrelated to our operating performance or prospects, or macro or industry fundamentals, which could occur for a number of reasons including but not limited to analyst recommendations, changes in our industry or the overall markets, significant acquisitions or other strategic transactions by or involving us or our subsidiaries, among other reasons; our operating business has a history of losses, is expected to incur additional losses, and may never achieve profitability; our past performance may not be a reliable indicator of future performance, including but not limited to in the event of a strategic transaction; historical trends should not be used to anticipate results or trends in future periods; our ability to increase our at-the-market offering availability in the future is subject to obtaining necessary approvals, certifications, legal opinions and accounting comfort letters, and there is no guaranty that we can do so successfully; we have identified material weaknesses in our internal control over financial reporting and these material weaknesses could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; compliance with Sarbanes-Oxley Act Section 404 could have a material adverse impact on our business; we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals or engage in a strategic transaction which realigns our business focus; our VIVO launch plans require significant investment in infrastructure and sales representatives; our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators; we have entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales; royalty agreements with respect to LockeT, the surgical vessel closing pressure device, will reduce any future profits from this product; if we experience significant disruptions in our information technology systems, our business may be adversely affected; litigation and other legal proceedings may adversely affect our business; if we make acquisitions or divestitures, we could encounter difficulties that harm our business, and entering into a strategic transaction could materially alter our business model and focus; failure to attract and retain sufficient qualified personnel could also impede our growth; our revenues may depend on our customers’ receipt of adequate reimbursement from private insurers and government sponsored healthcare programs; we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do; our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms; if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant operating revenue, if any; the recent coronavirus outbreak (“COVID-19”) adversely affected our financial condition and results of operations and we cannot provide any certainty as to whether there will be future impacts from COVID-19 or another pandemic; a variety of risks associated with marketing our products internationally could materially adversely affect our business; the impact of the military conflicts in Ukraine and Israel, and the actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our supply chain; if the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates; we may be adversely affected by product liability claims, unfavorable court decisions or legal settlements; our ability to use our net operating loss carryforwards may be limited; we are subject to pervasive and continuing regulation by the FDA and other regulatory agencies; our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business; changes in trade policies among the United States (“U.S.”) and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products; increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results; product clearances and approvals can often be denied or significantly delayed, although we have obtained regulatory clearance for our VIVO and LockeT products in the U.S. and certain non-U.S. jurisdictions; our current business plans for our current operating business include expanding uses for our products, which if implemented would require additional clearances; even after clearance is obtained, our products remain subject to extensive regulatory scrutiny; reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our products; our business may be adversely affected by changes and uncertainty in the health care industry including health care public‑policy developments; if we or our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, or any applicable state equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer; if any of our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions; healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets; if we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our existing products and any products we may develop, and our technology may be adversely affected; and there is no guarantee that we will be able to sell the QHS Notes, and any short-term sale may produce proceeds that are less than the market or stated value of such assets and less than the proceeds that could have been obtained if they were liquidated in the ordinary course. If we enter into a strategic transaction, such as a merger, acquisition or crypto treasury policy, we may become subject to additional risks in addition to those described above, which risks would be identified and disclosed in conjunction with consummating any such transaction. There is no guarantee that we will be able to identify and enter into any such strategic transaction.
The forward-looking statements in this report and identified above reflect our beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report and are subject to risks and uncertainties including those described in the cautionary statements above. Given these risks and uncertainties, you should not place undue reliance on the forward-looking statements. We qualify all of the forward-looking statements in this Quarterly Report by these cautionary statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events or otherwise.
This Quarterly Report also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.
References to “we”, “us”, “our”, "Catheter" and “the Company” refer to Catheter Precision, Inc.
Overview
Catheter Precision, Inc. was incorporated in California on September 4, 2002, and reincorporated in Delaware in July 2018. Catheter was initially formed to develop, commercialize, and market its advanced excimer laser-based platform for use in the treatment of vascular and dermatological immune-mediated inflammatory diseases. On January 9, 2023, the Company merged with the former Catheter Precision, Inc. (“Old Catheter”), a privately held Delaware corporation (the “Merger”), which became a wholly owned subsidiary of the Company. Our current activities primarily relate to Old Catheter’s historical business, which comprises the design, manufacture and sale of new and innovative medical technologies focused on the field of cardiac electrophysiology (EP).
On February 17, 2025, the Company formed a new subsidiary, Cardionomix, Inc. ("Cardionomix"), to acquire certain assets previously held by Cardionomic, Inc. ("Cardionomic"), a third-party entity that had ceased operations. We own 82% of Cardionomix’s issued and outstanding common stock. Our Chief Executive Officer and Chairman of the Board and certain of his affiliates own 12%, while the remaining 6% of the outstanding common stock was issued to certain third parties as finder's fees for the asset acquisition (see Note 2, Summary of Significant Accounting Policies in the condensed consolidated financial statements included elsewhere in this Quarterly Report). On May 5, 2025, Cardionomix acquired certain assets primarily related to the Cardiac Pulmonary Nerve Stimulation ("CPNS") System previously held by Cardionomic (see Note 14, Asset Acquisition in the consolidated financial statements included elsewhere in this Quarterly Report). The CPNS System is a novel technology for the late-stage treatment of acute decompensated heart failure by stimulating the autonomic cardiac nerves to restore autonomic balance. The CPNS System is in development and has yet to obtain regulatory approval.
On June 20, 2025, the Company formed a new subsidiary, KardioNav, Inc. ("KardioNav"), to pursue the advancement, development, and commercialization of certain intellectual property assigned to KardioNav. The Company transferred certain intellectual property related to the VIVO System to KardioNav, while Chelak iECG, Inc. ("Chelak"), an unrelated third party, transferred certain patents related to a medical device designed to interface with implanted cardiac devices to KardioNav. KardioNav intends to integrate the VIVO mapping intellectual property with Chelak's assigned patents to develop a system that interfaces with implanted cardiac devices to enable improved pre-ablation mapping and more precise localization of arrhythmogenic tissue. Research and development activities in animals and humans have begun. The Company owns 57% of the subsidiary's issued and outstanding common stock, while Chelak owns 33% of the subsidiary’s issued and outstanding common stock. The Company's Chief Executive Officer and Chairman of the Board of Directors and certain of his affiliates own the remaining 10% of the subsidiary’s issued and outstanding common stock. See Note 2, Summary of Significant Accounting Policies in the condensed consolidated financial statements included elsewhere in this Quarterly Report.
One of our two primary products is the View into Ventricular Onset (“VIVO” or “VIVO System”), which is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures.
We have received FDA clearance to market and promote the VIVO System in the U.S. as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias. VIVO allows for the acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. To date, VIVO has been utilized in more than 1,000 procedures in the U.S. and EU by over 30 physicians, with no reported device-related complications.
We have been cleared to label the VIVO System with the CE Mark in the EU and certain other countries. The CE Mark designation, which affirms the product’s conformity with European health, safety, and environmental protection standards, allows us to market that product in countries that are members of the EU and the European Free Trade Association. Catheter has commenced limited sales of the VIVO System in Europe and the UK through independent distributors. Catheter’s international distributors are supported by two EU-based full-time consultants.
Our second and newest primary product, LockeT® (“LockeT”), is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. LockeT is a sterile Class I product that was registered with the FDA in the U.S. We recognized our first sale of LockeT in May 2024. In September 2024, we received notification of the issuance of our first LockeT patent in the country of China and we also completed a Middle East distribution agreement for LockeT.
In April 2025, we received notification of the issuance of our first LockeT patent in the U.S. by the United States Patent and Trademark Office. In April 2025, Catheter also obtained the CE Mark approval for LockeT, permitting the marketing and sale of LockeT in the European Union, Switzerland and Turkey. Since receipt of the CE Mark, we have signed agreements with new distributors in the United Kingdom, Italy, Spain, Portugal, Switzerland, the Middle East, South Africa and Brunei.
Clinical studies for LockeT began during the year ended December 31, 2023. The current studies are planned to show the product’s effectiveness and benefits, including faster wound closure and patient ambulation/discharge, potentially resulting in higher procedural volumes and lower costs for the healthcare provider and/or insurance payor. These clinical studies are intended to provide crucial data for marketing and to expand our indications for use with the FDA. For more information about our clinical studies, refer to Item 1, Business in our Form 10-K.
Our business strategy is to become a leading medical device company in the field of cardiac electrophysiology, and we are dedicated to developing and delivering electrophysiology products to provide patients, hospitals, and physicians with novel technologies and solutions to improve the lives of patients with cardiac arrhythmias. We aim to establish our products as integral tools used by cardiac electrophysiologists and their colleagues during ablation treatment of ventricular arrhythmias by reducing procedure time, patient complications and increasing procedural success.
Recent Developments
PeriKard Asset Acquisition
On January 14, 2025, we entered into a Membership Interest Purchase Agreement ("Agreement”) with Cardiofront, LLC (“Seller”) to purchase the issued and outstanding membership interests of PeriKard, LLC, a wholly-owned subsidiary of Seller. The primary purpose of the acquisition was to purchase patented technology for commercialization within the broader cardiac treatment and electrophysiology industry. Pursuant to the Agreement, we issued 14,473 shares of our common stock valued at $113 thousand to the Seller in exchange for 100% of the membership interests of PeriKard, LLC. Furthermore, we may be obligated to make royalty payments equal to 10% of net sales of the pericardial access kit for five years following the closing date. The PeriKard pericardial access kit is a medical procedure kit and method for draining fluid from an organ. The technology is in development and has not been commercialized. This transaction closed on January 24, 2025.
The acquisition was accounted for as an asset acquisition consisting primarily of a single patent for pericardial access technology. The patent was determined to be in-process research and development ("IPR&D") with no alternative future use, and accordingly, we recognized $119 thousand, consisting of $113 thousand of stock consideration and $6 thousand of direct transaction costs, as acquired in-process research and development in the condensed consolidated statements of operations for the nine months ended September 30, 2025. As of September 30, 2025, we have not recognized a liability for the contingent royalty payments because they are currently not probable or reasonably estimable.
Cardionomic Asset Acquisition
On May 5, 2025, Cardionomix acquired the CPNS System. As consideration to Cardionomic, we issued 52,631 shares of our restricted common stock valued at $0.3 million, and Cardionomix issued a promissory note valued at $1.3 million (“Note Payable”). The Note Payable was issued with a principal balance of $1.5 million and stated interest of 4% per annum with no interest or principal payable until the maturity date, which is three years following the date of issuance. The acquisition was accounted for as an asset acquisition consisting primarily of the CPNS System, which was deemed to be an IPR&D Asset with no alternative future use. Accordingly, we recognized $1.9 million, consisting of $0.3 million of stock consideration, $1.3 million of note payable, and $0.3 million of direct transaction costs, as acquired in-process research and development in the condensed consolidated statement of operations for the nine months ended September 30, 2025.
The minority equity interest holders are presented as non-controlling interests in the accompanying condensed consolidated balance sheets, statements of operations, and statements of stockholders’ equity as of and for the nine months ended September 30, 2025.
May 2025 PIPE Financing
We determined that the Series L and Placement Agent Warrants do not require liability classification pursuant to ASC 480. Furthermore, the Series L and Placement Agent Warrants do not have any net cash settlement provisions that would preclude equity classification under ASC 815-40. Accordingly, the Series L and Placement Agent Warrants were recorded to additional paid-in capital in the condensed consolidated balance sheets.
See Note 11, Equity Offerings in the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information on the provisions for the Series L and Placement Agent Warrants. See Note 12, Preferred Stock in the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information on the Series B Convertible Preferred Stock issued in connection with the May 2025 PIPE Financing.
In addition, we entered into a registration rights agreement with the investors requiring the registration for resale the shares of common stock issuable upon the conversion of the Series B Convertible Preferred Stock and Series L Warrants. The registration statement became effective on May 30, 2025. Subject to specified exceptions, failure to maintain the registration statement shall lead to an obligation to pay to the investors cash liquidated damages equal to 2% of each investor’s subscription amount for then outstanding securities for every 30-day period the lapse continues, with unpaid amounts accruing interest at 18% per annum after a specified grace period.
During the nine months ended September 30, 2025, we issued 115,912 shares of common stock upon the conversion of 771 shares of our Series B Convertible Preferred Stock.
At the Market Offering Agreement
On May 19, 2025, we entered into an At Market Offering Agreement (“ATM Agreement”) with Ladenburg. Based on the original prospectus supplement filed by the Company, under the ATM Agreement, we could offer and sell up to $1.3 million of shares of common stock, par value $0.0001 per share, through Ladenburg. On June 13, 2025, the Company filed a prospectus supplement increasing the aggregate amount available to be sold to $3.2 million under the ATM ("Shares"). On August 7, 2025, the Company filed a prospectus supplement, which supersedes and replaces the prospectus supplement dated June 13, 2025, increasing the aggregate amount of shares available to be sold to $4.3 million. The Shares have been and will continue to be issued pursuant to the Company's previously filed and effective Registration Statement on Form S-3 (File No. 333-284217), which was initially filed with the Securities and Exchange Commission on January 10, 2025 and declared effective on January 22, 2025.
We have no obligation to sell, and Ladenburg is not obligated to buy or sell, any of the shares under the ATM Agreement and may at any time suspend offers under the ATM Agreement. The ATM Agreement will terminate upon the earlier of (i) the issuance and sale of all of the shares through Ladenburg on the terms and subject to the conditions set forth in the ATM Agreement or (ii) termination of the ATM Agreement as otherwise permitted thereby. The ATM Agreement may be terminated at any time by either party upon five (5) business days’ prior notice, or by Ladenburg at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.
On June 20, 2025, the Company formed KardioNav to pursue the advancement, development, and commercialization of certain intellectual property assigned to KardioNav. The Company transferred certain intellectual property related to the VIVO System to KardioNav, while Chelak, an unrelated third party, transferred certain patents related to a medical device designed to interface with implanted cardiac devices to KardioNav. KardioNav intends to integrate the VIVO mapping intellectual property with Chelak's assigned patents to develop a system that interfaces with implanted cardiac devices to enable improved pre-ablation mapping and more precise localization of arrhythmogenic tissue. Research and development activities are in the planning phase for this medical device. The Company owns 57% of the subsidiary's issued and outstanding common stock, while Chelak owns 33% of the subsidiary’s issued and outstanding common stock. The Company's Chief Executive Officer and Chairman of the Board of Directors and certain of his affiliates own the remaining 10% of the subsidiary’s issued and outstanding common stock.
The minority equity interest holders are presented as non-controlling interest in the accompanying condensed consolidated balance sheet, statement of operations, and statement of stockholders’ equity as of and for the nine months ended September 30, 2025. See Note 2, Summary of Significant Accounting Policies in the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
Components of our Results of Operations for the Three and Nine Months Ended September 30, 2025 and 2024
Revenues
Our current activities primarily relate to the design, manufacture and sale of new and innovative medical technologies in the field of cardiac electrophysiology. Our two primary products are (i) the VIVO System and (ii) the LockeT device.
The VIVO System provides 3D cardiac mapping to aid with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to electrophysiology studies. Customers also have the option to purchase software upgrades in advance at contract inception. We invoice the customer for VIVO System and related software upgrade services after physical possession and control of VIVO System has been transferred. Subsequent renewals for software upgrade services are invoiced at inception of the renewed term. The timing of payment for the corresponding invoices depends on the credit terms identified in each contract. We recognize revenues for VIVO System at the point in time that the product is delivered to the customer. We recognize revenues for software upgrade services evenly over time over the term of the contract. We did not recognize any revenues for software upgrade services for the three and nine months ended September 30, 2025 and 2024.
LockeT is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure. We recognize sales of LockeT at the point in time that the product is delivered to the customer.
We are a business that has operations within multiple countries. During the three and nine months ended September 30, 2025, approximately 24% and 17%, respectively, of our sales were derived from customers outside of the United States. During the three and nine months ended September 30, 2024, approximately 35% and 52%, respectively, of our sales were derived from customers outside of the United States.
Cost of revenues
Cost of revenues for product sales consists primarily of component costs, labor costs, and manufacturing overhead incurred to produce our products and support production.
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses consist of employee-related costs, including salaries, benefits and stock-based compensation expenses. Other SG&A expenses include amortization of intangible assets, depreciation of fixed assets, professional services fees, including legal, audit and tax fees, insurance fees, general corporate expenses and facility-related expenses.
Research and development expenses
Research and development (“R&D”) expenses are expensed as incurred and include research grants paid to other parties, product development, costs of clinical studies to support new products and product enhancements, including expanded indications, supplies used for internal R&D and clinical activities, and costs for outside consultants who assist with technology development and clinical affairs.
Acquired in-process research and development expenses
Assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as IPR&D. Acquired IPR&D that has no alternative future use as of the acquisition date is recognized as research and development expense as of the acquisition date.
Results of Operations for the Three and Nine Months Ended September 30, 2025 and 2024
The following table sets forth the results of the Company's operations for the periods presented (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
|
2025 |
2024 |
Change |
2025 |
2024 |
Change |
|||||||||||||||||||
|
Revenue |
$ | 226 | $ | 96 | $ | 130 | $ | 581 | $ | 271 | $ | 310 | ||||||||||||
|
Cost of revenues |
18 | 10 | 8 | 43 | 31 | 12 | ||||||||||||||||||
|
Selling, general and administrative expenses |
2,953 | 2,882 | 71 | 9,319 | 8,251 | 1,068 | ||||||||||||||||||
|
Research and development expenses |
276 | 63 | 213 | 534 | 181 | 353 | ||||||||||||||||||
|
Acquired in-process research and development expenses |
— | — | - | 1,967 | — | 1,967 | ||||||||||||||||||
|
Change in fair value of royalties payable due to related parties |
726 | (1,233 | ) | 1,959 | (2,104 | ) | (2,823 | ) | 719 | |||||||||||||||
|
Change in fair value of trading debt securities |
107 | — | 107 | 117 | — | 117 | ||||||||||||||||||
|
Other (expense) income, net (1) |
(78 | ) | (28 | ) | (50 | ) | (174 | ) | — | (174 | ) | |||||||||||||
|
Income tax benefit (provision) |
(78 | ) | — | (78 | ) | 1,596 | — | 1,596 | ||||||||||||||||
(1) Constitutes the operating activities within other income (expense), net in the consolidated statements of operations, except for the change in fair value of royalties payable due to related parties and change in fair value of trading debt securities that are presented separately in the table above.
Revenues
The increase in revenues of approximately $130 thousand for the three months ended September 30, 2025 as compared to the corresponding period in the prior year was due to an increase of $92 thousand and $38 thousand in LockeT and VIVO System sales, respectively. The increase in revenues of approximately $310 thousand for the nine months ended September 30, 2025 as compared to the corresponding period in the prior year was due to an increase of $322 thousand in LockeT sales, partially offset by a $12 thousand decrease in VIVO System sales. The increase in LockeT sales is primarily the result of our sales team's efforts to effectively prove the procedural efficiency, cost-effectiveness and improved patient experience resulting from the use of LockeT compared with incumbent or competing closure devices to prospective new hospital customers. Accordingly, we have entered into long-term contracts with a number of those hospitals, which has resulted in receiving initial and repeat orders as the LockeT devices are used and consumed in clinical procedures. The nine-month period to date decrease in VIVO System sales was primarily driven by an overall reduction in VIVO patch sales in the European Union ("EU"), which accounted for the majority of product sales in 2024. This decline was primarily attributable to reduced sales efforts resulting from changes in commercial leadership and the prolonged medical leave of a key EU-based sales consultant throughout 2024 and during the nine months ended September 30, 2025.
Cost of revenues
The increase in cost of revenues of approximately $8 thousand and $12 thousand for the three and nine months ended September 30, 2025, respectively, as compared to the corresponding period in the prior year was primarily due to an increase in LockeT sales, partially offset by higher product margins for LockeT devices. We submitted larger consolidated purchase orders, received larger volume-based, supplier discounts, and achieved a higher product margin for LockeT devices for the three and nine months ended September 30, 2025 as compared to the corresponding period in the prior year.
Selling, general and administrative expenses
The increase in selling, general and administrative expenses of approximately $0.1 million for the three months ended September 30, 2025 as compared to the corresponding period in the prior year was due to an increase in professional fees of $0.2 million and an increase in stock-based compensation expense of $0.1 million, partially offset by a decrease in salaries and benefits of $0.2 million. The increase in professional fees primarily relates to an increase in accounting and audit fees, while the increase in stock-based compensation expense primarily relates to an increase in plan and non-plan options granted to certain employees and directors. The decrease in salaries and benefits was primarily due to the departure of the Chief Commercial Officer at the end of the second quarter of 2025 as well as the termination of two employees during the three months ended September 30, 2025 as compared to the corresponding period in the prior year. None of the terminated employees have been replaced.
The increase in selling, general and administrative expenses of approximately $1.1 million for the nine months ended September 30, 2025 as compared to the corresponding period in the prior year was due to an increase in salaries and benefits of $0.7 million, an increase in stock-based compensation expense of $0.2 million, and an increase in professional fees of $0.2 million. The increase in salaries and benefits was primarily due to an increase in headcount of sales employees in the second quarter of 2024 that worked for the Company for the entirety of 2025. Additionally, the CFO position that had been vacant for most of 2024 was filled in January 2025. The increase in salaries and benefits is partially offset by the departure of certain employees in 2025 that have not been replaced during the nine months ended September 30, 2025. The increase in stock-based compensation expense primarily relates to an increase in plan and non-plan options granted to certain employees and directors, while the increase in professional fees primarily relates to an increase in accounting and audit fees.
Research and development expenses
The increase in research and development expenses of approximately $0.2 million for the three months ended September 30, 2025, as compared to the corresponding period in the prior year, was primarily due to an increase in professional fees o f $0.1 million and an increase in salaries and benefits of $0.1 million.
The increase in research and development expenses of approximately $0.4 million for the nine months ended September 30, 2025, as compared to the corresponding period in the prior year, was primarily due to an increase in professional fees of $0.2 million and an increase in salaries and benefits of $0.2 million. The increase in professional fees primarily relates to research and development activities led by Chelak, which was engaged by KardioNav to develop a system that interfaces with implanted cardiac devices to enable improved pre-ablation mapping and more precise localization of arrhythmogenic tissue. The increase in salaries and benefits primarily relates to a full-time employee, who is solely tasked with research and development activities, and who was hired in January 2025.
Acquired in-process research and development expenses
The increase in acquired in-process research and development expenses of approximately $2.0 million for the nine months ended September 30, 2025 as compared the corresponding period in the prior year primarily relates to two of the asset acquisitions completed in 2025. On January 24, 2025, we acquired 100% of the membership interests of Perikard, LLC for $119 thousand. Since the acquired assets were deemed to be IPR&D with no alternative future use, we recognized total acquisition costs of $119 thousand as acquired in-process research and development in the condensed consolidated statements of operations for the nine months ended September 30, 2025. On May 5, 2025, we acquired certain assets primarily related to Cardionomic’s CPNS System, which were also deemed to be IPR&D assets with no alternative future use. Accordingly, we recognized $1.9 million as acquired in-process research and development in the condensed consolidated statements of operations for the nine months ended September 30, 2025.
Change in fair value of royalties payable due to related parties
At each reporting period, the fair value of the royalties payable due to related parties is calculated using the discounted cash flow method. The change in fair value of royalties payable due to related parties decreased approximately $2.0 million and $0.7 million for the three and nine months ended September 30, 2025, respectively, as compared to the corresponding period in the prior year. The decrease primarily reflects lower projected LockeT sales growth and a reduction in the discount rate which decreased to 19.5%.
Change in fair value of trading debt securities
The change in fair value of trading debt securities of $107 thousand and $117 thousand for the three and nine months ended September 30, 2025, respectively, as compared to the corresponding periods in the prior year, relate primarily to the QHSLab Notes, which were received as consideration for the Series B Convertible Preferred Stock and Series L Warrants issued on May 12, 2025.
Other (expense) income, net
The increase in other expense, net of $50 thousand and $174 thousand for the three and nine months ended September 30, 2025, respectively, as compared to the corresponding periods in the prior year, primarily relates to an increase in interest expense incurred in connection with the note payable issued by Cardionomix on May 5, 2025 and the short-term note payables issued by KardioNav on July 11, 2025.
Income tax benefit (provision)
The increase in income tax provision of approximately $78 thousand for the three months ended September 30, 2025 and an increase in income tax benefit of $1.6 million for the nine months ended September 30, 2025, as compared to the corresponding periods in the prior year primarily relates to changes in the estimated amount of net operating losses that are not subject to limitations under Section 382 of the Internal Revenue Code .
Liquidity and capital resources
As of September 30, 2025, we had cash and cash equivalents of $1.1 million and an accumulated deficit of $303.8 million. For the nine months ended September 30, 2025, net cash used in operating activities was $6.8 million. We have incurred recurring net losses from operations and negative cash flows from operating activities since inception.
On May 12, 2025, we raised gross proceeds of $1.5 million in cash and acquired $0.9 million in trading debt securities, before deducting placement agent fees and offering expenses of $0.4 million, in connection with the May 2025 PIPE Financing. Through September 30, 2025, we raised gross proceeds of $4 million, before deduction of commissions and offering expenses of $0.3 million, in connection with the ATM. See Note 11, Equity Offerings in the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information on the financing events.
We expect operating losses and negative cash flows to continue for the foreseeable future unless our sales and gross profit increase sufficiently to cover our operating expenses. We expect our current operating expenses to remain relatively fixed for the near term, absent entering into a transformative strategic transaction. We believe that our current cash on hand of $377 thousand as of November 5, 2025 will not be sufficient to fund our current operations, and if we are unable to secure additional financing we will be unable to fund planned expenditures and meet obligations through the end of the fourth quarter. Further, we have outstanding short-term notes that will become due and payable within the next twelve months, including notes to related parties which come due in January of 2026, and in July of 2026. Therefore, even if we obtain financing in the fourth quarter, depending upon the amount of any financing we do obtain, we may continue to experience insufficient liquidity for the foreseeable future. We are currently evaluating potential means of raising cash, as described below, to fund our operations and to pay our debts as they come due. If we are unable to do so, we will be required to reduce our spending to align with expected revenue levels and cash reserves, although there can be no guarantee that we will be successful in doing so. If we are unable to do so, we will be required to suspend a portion or all of our operations and/or potentially seek relief from our creditors. We may not be able to secure financing in a timely manner or on favorable terms, if at all.
As described above and previously disclosed, the Company remains committed to the aggressive and creative pursuit of financing, despite great challenges to securing capital on our preferred terms. Any assets that are liquidated to meet our current urgent liquidity needs may produce proceeds that are less than the market or stated value of such assets and less than the proceeds that could have been obtained if they were liquidated in the ordinary course. Due to the challenging economic environment, we have explored and continue to explore a wide variety of possible capital-raising and strategic transactions, including but not limited to private equity offerings, registered issuances, credit facilities, and convertible debt, or sale of the QHS Notes, as well as other innovative and specialty finance strategies such as a crypto asset treasury policy or business combination. There is no guarantee that we will succeed in securing the financing or other strategic transaction needed to sustain the Company or that any such transaction will be on our preferred terms.
As a result of these factors, we have concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date the condensed consolidated financial statements for the quarter ended September 30, 2025 are issued. The Company’s condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Cash Flows for the Nine Months Ended September 30, 2025 and 2024 (in thousands)
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Nine Months Ended September 30, |
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2025 |
2024 |
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Net cash provided by (used in): |
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|
Operating activities |
$ | (6,784 | ) | $ | (6,407 | ) | ||
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Investing activities |
(51 | ) | (67 | ) | ||||
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Financing activities |
5,037 | 4,177 | ||||||
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Net change in cash and cash equivalents |
$ | (1,798 | ) | $ | (2,297 | ) | ||
Net cash used in operating activities
During the nine months ended September 30, 2025, net cash used in operating activities of $6.8 million primarily related to the net loss of $11.8 million. This was partially offset by an increase in operating assets and liabilities of $0.8 million and non-cash adjustments related to change in fair value of royalties payable due to related parties of $2.1 million and acquired in-process research and development of $2.0 million.
During the nine months ended September 30, 2024, net cash used in operating activities of $6.4 million primarily related to the net loss of $11.0 million, partially offset by an increase in operating assets and liabilities of $0.2 million and non-cash adjustments primarily consisting of change in fair value of royalties due to related parties of $2.8 million and depreciation and amortization of $1.6 million.
Net cash used in investing activities
During the nine months ended September 30, 2025, net cash used in investing activities of $51 thousand consisted of purchases of property and equipment of $17 thousand and purchases of acquired in-process research and development of $34 thousand.
During the nine months ended September 30, 2024, net cash used in investing activities of $67 thousand consisted of purchases of property and equipment.
Net cash provided by financing activities
During the nine months ended September 30, 2025, net cash provided by financing activities of $5.0 million consisted of net proceeds from issuance of common stock and other equity-classified instruments of $4.9 million, and proceeds from the issuance of notes payable of $0.3 million, partially offset by $0.2 million in payments on notes payable.
During the nine months ended September 30, 2024, net cash provided by financing activities of $4.2 million primarily consisted of proceeds from issuance of common stock and other equity-classified instruments of $2.6 million and proceeds from the issuance of notes payable due to related parties of $1.5 million.
Off-balance sheet arrangements
We have not engaged in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, as a part of our ongoing business. Accordingly, we did not have any off-balance sheet arrangements during any of the periods presented.
The Company ’ s Critical Accounting Estimates
The information set forth below relates to the Company’s critical accounting policies and estimates. The discussion and analysis of our financial position and results of operations is based on our condensed consolidated financial statements included elsewhere in this Quarterly Report, which have been prepared in accordance with U.S. GAAP.
The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. We regularly evaluate estimates and assumptions related to asset acquisitions, including the provisions for legal contingencies, income taxes, deferred income tax asset valuation allowances, royalties payable due to related parties, trading debt securities, share based compensation, evaluation of impairment of long-lived assets, valuation of long-lived assets and their associated estimated useful lives, and revenues. Our estimates are based on current facts, historical experience and 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 may differ from these estimates under different assumptions or conditions and any such differences may be material.
We believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.
Accounting for long-lived assets - estimated useful lives
Intangible assets acquired from business combinations are initially measured at their estimated fair values and are then amortized on a straight-line basis over their estimated useful lives. Management evaluates whether events or circumstances have occurred that indicate the remaining useful life or carrying value of the amortizing intangible assets should be revised and adjusted, if necessary.
Accounting for impairment of long-lived assets
The Company periodically reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that such assets might be impaired and the carrying value of the long-lived assets may not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and the expected undiscounted future cash flows attributable to the asset are less than the carrying amount of the asset, an impairment loss equal to the excess of the assets carrying value over its fair value is recorded in the Company’s condensed consolidated statements of operations at that date.
Trading Debt Securities
The Company holds Level 3 trading debt securities that are measured at fair value with changes in fair value recognized in earnings. Because there is no observable market for these notes and their fair value depends on multiple, significant unobservable inputs, determining fair value requires significant judgment and could materially affect the Company’s results of operations. The fair value of the trading debt securities is determined using a probability weighted expected return model (“PWER model”) that values the trading debt securities based on the discounted cash flows of two potential settlement outcomes: (i) the trading debt securities will be converted into and settled in shares of common stock of QHSLab, Inc. and (ii) the trading debt securities’ principal and accrued interest will be paid. Aside from the probability of the two potential settlement outcomes, the fair value measurement incorporates several significant unobservable inputs, including the recovery rate, simulated conversion price, credit-risk adjusted discount rate, expected equity volatility, and expected term.
Royalties payable
The Company is obligated to pay royalties related to the sales of LockeT and AMIGO System under various royalty agreements executed by Old Catheter. The Company recognizes a liability for royalty fees incurred and payable based on actual sales of products under current portion of royalties payable due to related parties in the condensed consolidated balance sheets. The Company recognizes a liability for future, estimated royalty payments at fair value under current portion of royalties payable due to related parties and royalties payable due to related parties in the condensed consolidated balance sheets if it is payable within the next 12 months and under royalties payable due to related parties in the condensed consolidated balance sheets if it is payable 12 months after the balance sheet date. The royalties payable due to related parties are remeasured at each reporting period. Changes in fair value of royalties payable due to related parties are recorded on the condensed consolidated statements of operations in the period in which they occur.
The fair value measurement of royalties payable due to related parties includes significant unobservable inputs that are not supported by any market data. Royalties payable due to related parties equal the present value of estimated future royalty payments. The Company applies an internally developed, revenue adjusted discount rate (“RADR”) to discount back the forecasted royalty payments. The RADR is based on the Company’s weighted average cost of capital (“WACC”) adjusted for the product revenue’s risk profile. The risk-free rate used to determine the cost of equity for the RADR is adjusted to be commensurate with the term of the royalty agreements. Furthermore, the Beta and Risk Premium used to determine the cost of equity are also adjusted to reflect the product revenue's volatility. All other inputs for the RADR and the Company’s WACC are the same.
New Accounting Pronouncements
See Note 2 in the condensed consolidated financial statements included elsewhere in this Quarterly Report for a description of new accounting pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial position, and cash flows as applicable.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Executive Chairman of the Board and Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2025. Our objective in designing our disclosure controls and procedures is that they provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based upon this evaluation, due to the existence of the material weaknesses found in our internal controls over financial reporting described below, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2025, our disclosure controls and procedures were not effective at the reasonable assurance level. As disclosed in our Form 10-K for the year ended December 31, 2024, for the reasons set forth therein, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and procedures were not effective at the reasonable assurance level. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. In preparation of our financial statements for the period covered by this report, we identified material weaknesses in internal control over financial reporting related to our control environment that existed as of September 30, 2025, as described below. Specifically, we identified material weaknesses with respect to (1) the lack of segregation of duties, (2) the lack of designed and operating review controls with respect to oversight of the financial reporting process, and (3) review of work performed by service providers with regards to (i) management's provision of inputs for valuations to a third-party provider and (ii) the Section 382 calculation in the tax provision in that the Company's provision did not reference the correct dates when determining ownership changes resulting in material changes in the amount of expiring net operating losses available to be utilized. Notwithstanding the identified material weaknesses, management believes that the Financial Statements and related financial information included in this Quarterly Report fairly present, in all material respects, our balance sheets, statements of operations, shareholders’ equity and cash flows as of and for the periods presented.
Remediation Plan
Management has developed and implemented a remediation plan. The material weaknesses will not be considered remediated until management designs and implements effective controls that operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. The Company will monitor the effectiveness of its remediation plan and will make changes management determines to be appropriate. Anticipated remediation measures include continuing assessment of the need to expand the Company’s current accounting and financial reporting teams to include individuals with requisite experience to meet the requirements associated with the increasing operations of a publicly traded company, establishment of policies and procedures to ensure full review and sign offs with respect to the inputs sent to third-party service providers as well as the reports and documentation upon the completion of their work prior to any adjustments being made to the financial statements, and establishment of policies and procedures to review the inputs to fair value and tax provision calculations as well as the outputs impacting the balance at each reporting period. In January 2025, we hired a new Chief Financial Officer and established additional controls intended to eliminate the disclosed material weaknesses.
Changes in Internal Control over Financial Reporting
There have been no changes in the Company’s internal control over financial reporting during the quarter ended September 30, 2025, which were identified in connection with management's evaluation required by paragraph (d) of Rule 13a-15 under the Securities Exchange Act of 1934, as amended, and that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Reference is made to the information disclosed under Item 3 — " Legal Proceedings " in our Annual Report on Form 10-K for the year ended December 31, 2024.
Not required.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
During the three months ended September 30, 2025 , director or officer, as defined in Rule 16a - 1 (f) under the Securities Exchange Act of 1934, as amended, of the Company adopted or terminated a "Rule 10b5 - 1 trading arrangement" or "non-Rule 10b5 - 1 trading arrangement," as each term is defined in Item 408 (a) of Regulation S-K.
On July 11, 2025, two short term promissory notes of $150 thousand each were issued by the Company’s majority-owned subsidiary KardioNav to David Jenkins, the Company's Chairman of the Board and Chief Executive Officer, and Lifestim, Inc., a company controlled by Mr. Jenkins, in exchange for an aggregate loan of $300 thousand. The promissory notes have a maturity date of July 11, 2026, and interest rates of 4.2% per annum, with all principal and interest payable upon maturity. As of September 30, 2025, $300 thousand of principal was outstanding on the notes.
The notes, including all principal and interest, accelerate and become immediately due and payable upon the occurrence of certain customary events of default, including failure to pay amounts owed when due, material breach of the Company’s representations or warranties (unless waived by the holders or cured within 10 days following notice), certain events involving the discontinuation of the Company’s business and/or certain types of proceedings involving insolvency, bankruptcy, receivership and the like.
|
S-1/A |
333-262195 |
4.9 |
2/3/2022 |
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| 8-K | 001-38677 | 4.1 | 7/22/2022 | |||||||
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8-K |
001-38677 |
4.4 |
2/9/2022 |
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10-Q |
001-38677 |
4.7 |
8/15/2022 |
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|
8-K |
001-38677 |
4.2 |
9/6/2024 |
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8-K |
001-38677 |
4.3 |
9/6/2024 |
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|
8-K |
001-38677 |
4.1 |
10/25/2024 |
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8-K/A |
001-38677 |
4.2 |
11/4/2024 |
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| 4.22 | Form of Underwriters' Warrant offered in September 2024 | S-1 | 333-279930 | 4.17 | 6/26/2024 | |||||
| 4.23 | Form of Warrant Agency Agreement dated as of September 3, 2024 entered into by and between the Registrant and Equiniti Trust Company, LLC | 8-K | 001-38677 | 4.5 | 9/6/2024 | |||||
| 4.24 | Form of Series L Warrant offered in May 2025. | 8-K | 001-38677 | 4.1 | 5/13/2025 |
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101.INS* |
Inline XBRL Instance Document |
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101.SCH* |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL* |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF* |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB* |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE* |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104* |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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* |
Filed herewith. |
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@ |
The information in this exhibit is furnished and deemed not filed with the Securities and Exchange Commission for purposes of section 18 of the Exchange Act of 1934, as amended (Exchange Act), and is not to be incorporated by reference into any filing of Catheter Precision, Inc. under the Securities Act of 1933, as amended (Securities Act), or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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.
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CATHETER PRECISION, INC.
(Registrant) |
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Date: November 13, 2025 |
By: |
/s/ David A. Jenkins |
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David A. Jenkins Executive Chairman of the Board and Chief Executive Officer (Principal Executive Officer) |
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Date: November 13, 2025 |
By: |
/s/ Philip Anderson |
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Philip Anderson |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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