Organization, Description of Business, Going Concern and Significant Risks and Uncertainties |
6 Months Ended |
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Jun. 30, 2026 | |
| Organization, Description of Business, Going Concern and Significant Risks and Uncertainties [Abstract] | |
| Organization, Description of Business, Going Concern and Significant Risks and Uncertainties |
Note 1 — Organization, Description of Business, Going Concern and Significant Risks and Uncertainties
Description of Business
Profusa, Inc. (the “Company”), originally incorporated in California on May 11, 2009, develops biointegrated sensors designed to provide continuous, clinical-grade monitoring of body chemistry for personal and medical use.
The Company’s first offering in the European Union, the Lumee™ Oxygen Platform, monitors tissue oxygen levels and is intended for applications such as peripheral artery disease, chronic wounds (including diabetic ulcers and pressure sores), and reconstructive surgery. The Company’s research and development efforts are primarily focused on the Lumee™ Glucose Platform, a continuous glucose monitor (“CGM”) consisting of a biocompatible gel injected under the skin that monitors interstitial glucose levels for several months from a single injection, offering an alternative to traditional finger-stick glucometers and short-term needle-type CGMs.
On July 11, 2025 (the “Closing Date”), NorthView Acquisition Corporation (“Northview”) consummated its business combination (the “Business Combination”) with Profusa, Inc., a California corporation (“Legacy Profusa”), pursuant to the Merger Agreement and Plan of Reorganization, dated November 7, 2022 (as amended, the “Merger Agreement”), among Northview, Legacy Profusa, and NV Profusa Merger Sub Inc., a wholly-owned Delaware subsidiary of Northview (“Merger Sub”). At closing, Merger Sub merged with and into Legacy Profusa (the “Merger”), with Legacy Profusa surviving as a wholly-owned subsidiary of Northview. In connection with the closing, Northview changed its name to “Profusa, Inc.”
Going Concern
The Company has incurred significant net operating losses from operations. As of June 30, 2026, the Company had a working capital deficit of approximately $27.3 million. For the six months ended June 30, 2026, the Company incurred a net loss of $12.2 million and used $5.2 million of cash in operating activities. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of research and development activities. The Company has been able to finance its operations primarily with the proceeds from the issuance of equity and debt instruments. Additional funds may be necessary to maintain current operations and will be required for successful product commercialization efforts.
On February 11, 2025, Northview executed a Securities Purchase Agreement (the “PIPE Subscription Agreement”) with Ascent Partners Fund LLC (“Ascent” or together with any party who may become party to the PIPE Subscription Agreement, the “PIPE Investors”). As of April 2026, the Company has remaining borrowing capacity under the PIPE Subscription Agreement of $12.2 million in principal, and issued $1.7 million of Ascent PIPE Notes. On August 12, 2026, the Company executed the 5th amendment to the Ascent Convertible Note Agreement for which the Company received an additional tranche of $0.7 million on August 13, 2026. As of the issuance date of these condensed consolidated financial statements, the Company has $9.8 million of principal available for draw down under the PIPE Subscription Agreement subject to certain conditions, which the investor may provide at its discretion.
On July 28, 2025 (the “effective date”), the Company entered into the Equity Line of Credit (“ELOC”) Securities Purchase Agreement (the “ELOC Purchase Agreement”) and the ELOC Registration Rights Agreement (the “ELOC Registration Rights Agreement”) with Ascent (the “Committed Equity Facility”). Upon the terms and subject to the satisfaction of the conditions contained in the PIPE Subscription Agreement, from and after the effective date, the Company will have the right, in its sole discretion, to sell to Ascent up to $100.0 million of shares of the Company’s common stock, subject to certain limitations set forth in the ELOC Purchase Agreement, from time to time during the term of the ELOC Purchase Agreement. Sales of common stock under the ELOC Purchase Agreement, and the timing of any such sales, are solely at the Company’s option, and the Company is under no obligation to sell any securities to Ascent under the ELOC Purchase Agreement. During the three and six months ended June 30, 2026, approximately $2.5 million and $2.9 million representing 89,806 and 93,020 shares, respectively, of the Company’s common stock were sold pursuant to the ELOC Purchase Agreement. The Company has entered into this strategic Committed Equity Facility in order to continue to fund its operating cash flows. As of the issuance date of these condensed consolidated financial statements, the Company has $86.9 million of common stock available for issuance to Ascent under the Committed Equity Facility.
Lumee Oxygen received regulatory approval in Europe through the attainment of a CE mark, which subsequently lapsed in 2020. The Company is working to obtain a renewed CE Mark for commercialization in Europe in order to generate revenues. In addition to management’s focus on commercialization, additional financing is available through the ELOC Purchase Agreement and executing remaining tranches of the PIPE Subscription Agreement which would provide an aggregate of up to an additional $12.2 million in cash for operating expenses to further the product research and development.
On September 11, 2025, Nasdaq notified the Company that it is not in compliance with the Minimum Bid Price Requirement and the Market Value of Listed Securities (“MVLS”) Requirement and provided the Company with an initial 180-day compliance period, or until March 10, 2026, to regain compliance. On October 27, 2025, Nasdaq further notified the Company that its market value of publicly held shares had been below the Market Value Requirement for the prior 30 consecutive business days and provided the Company with an initial 180-day compliance period, or until April 27, 2026, to regain compliance with the requirement.
On March 11, 2026, Nasdaq notified the Company that it had not regained compliance with the Minimum Bid Price Requirement or the MVLS Requirement by the March 10, 2026 deadline and that the Company’s securities were therefore subject to delisting from The Nasdaq Global Market on those bases. The Company appealed that determination and appeared before the Nasdaq Hearings Panel on April 21, 2026. On April 28, 2026, Nasdaq also notified the Company that it had not regained compliance with the Market Value of Publicly Held Shares (“MVPHS”) Requirement by the April 27, 2026 deadline, that this constituted an additional basis for delisting, and that the Nasdaq Hearings Panel would consider this deficiency in connection with its decision. The Company submitted its response within the required timeframe.
On May 6, 2026, Nasdaq notified the Company that the Nasdaq Hearings Panel had granted the request for continued listing on Nasdaq subject to certain conditions. As a condition to the exception, the Company was required to file an application to transfer its listing to The Nasdaq Capital Market by May 11, 2026, obtain stockholder approval for a reverse stock split by June 23, 2026 and to demonstrate compliance with the minimum bid price requirement and Nasdaq’s stockholders’ equity requirement by July 20, 2026. On July 10, 2026, Nasdaq approved the Company’s request for an extension until July 31, 2026 to demonstrate compliance. The Company was also required to promptly notify the Panel of any significant events during the exception period that could affect the Company’s compliance, and the Panel reserved the right to reconsider the terms of the exception if it determined continued listing was inadvisable or unwarranted. On May 13, 2026, the Company received Nasdaq’s notice confirming the Company’s transfer to The Nasdaq Capital Market, effective on May 15, 2026.
Pursuant to the execution of the Option Agreement described in Note 13, the Company legally issued shares of common stock and Series A Non-Voting Convertible Preferred Stock on July 31, 2026 and there are no remaining conditions that would affect the recognition of the issued equity. Therefore, the Company believes that as of July 31, 2026, it had at least $2.5 million of stockholders’ equity as required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1), which represents an alternative continued listing standard to the $35.0 million market value of listed securities requirement under Nasdaq Listing Rule 5550(b)(2). As of the date these condensed consolidated financial statements were issued, the Company was awaiting formal confirmation from Nasdaq that it had demonstrated compliance with the applicable continued listing requirement.
There can be no assurance that the Company will timely satisfy the conditions of the exception, regain compliance with Nasdaq’s continued listing standards, maintain compliance with Nasdaq’s continued listing standards thereafter, or otherwise maintain the listing of its securities on Nasdaq. If the Company does not timely regain compliance with the applicable Nasdaq listing requirements, Nasdaq may commence delisting proceedings, suspend trading in the Company’s securities, or otherwise take action that could result in the removal of the Company’s securities from Nasdaq. Any such event could materially and adversely affect the liquidity and market price of the Company’s securities, limit the Company’s ability to raise capital, and adversely affect the Company’s business, financial condition, and results of operations.
The Company’s condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, increased tariffs, cash requirements for the upcoming year, funding capacity, net working capital deficit, and future access to capital.
As of June 30, 2026, there continue to be factors which raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from the outcome of this uncertainty. |