Profusa, Inc 10-Q for FY2026 Q1
Profusa, Inc. (PFSA)
About this 10-Q
Profusa, Inc filed this 10-Q on May 15, 2026, covering the quarter ended March 31, 2026 (FY2026 Q1).
Headline figures
Quarter ended March 31, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $3.46M
- compared with a net loss of $2.72M a year earlier
- Diluted EPS
- -$2.05
- compared with -$105.09 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period
ended
OR
For the transition period from _______ to ______
Commission File No.
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The |
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
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of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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| ☒ | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check
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Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ☐ No
As of May 13, 2026, there were
Table of Contents
i
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
PROFUSA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(UNAUDITED)
| March 31, 2026 | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Digital assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Other non-current assets | ||||||||
| Right-of-use asset | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Excise tax payable | ||||||||
| Accrued expenses and other current liabilities | ||||||||
| Due to related party | ||||||||
| Convertible notes payable and loans payable at fair value | ||||||||
| Promissory notes and other | ||||||||
| Convertible and promissory notes payable to related parties | ||||||||
| PPP loan | ||||||||
| Total current liabilities | ||||||||
| Warrant liabilities at fair value | ||||||||
| Loans payable at fair value | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ Deficit: | ||||||||
| Undesignated preferred stock: $ | ||||||||
| Common stock: $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders’ deficit | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
PROFUSA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(UNAUDITED)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expenses) | ||||||||
| Loss on change in the fair value of convertible notes | ( | ) | ( | ) | ||||
| Gain on change in fair value of warrant liabilities | ||||||||
| Loss on disposal of digital assets | ( | ) | ||||||
| Interest expense (including related parties amounts of $ | ( | ) | ( | ) | ||||
| Gain on extinguishment of PPP loan | ||||||||
| Financing costs | ( | ) | ||||||
| Other income (expense) | ( | ) | ||||||
| Total other income (expense), net | ( | ) | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Net loss per share, basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted-average common shares outstanding, basic and diluted | ||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
PROFUSA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
(UNAUDITED)
| Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C/C-1 Convertible Preferred Stock | Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||||||||||||||||||||
| Balance at January 1, 2026 | — | $ | — | $ | — | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||
| Issuance of shares in connection with exercise of ELOC | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Issuance of shares in connection with the conversion of the PIPE note | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at January 1, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
PROFUSA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Noncash interest expense | ||||||||
| Gain on extinguishment of debt | ( | ) | ||||||
| Loss on change in fair value of convertible notes | ||||||||
| Stock-based compensation expense | ||||||||
| Gain on change in fair value of warrant liabilities | ( | ) | ||||||
| Loss on disposal of digital assets | ||||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Other non-current assets | ( | ) | ||||||
| Accounts payable | ||||||||
| Accrued expenses and other current liabilities | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Sale of digital assets | ||||||||
| Purchase of property, plant and equipment | ( | ) | ||||||
| Net cash provided by investing activities | ||||||||
| Cash flows from financing activities | ||||||||
| Proceeds from ELOC | ||||||||
| Repayment on convertible notes, promissory notes and loans payable | ( | ) | ||||||
| Proceeds from issuance of senior notes | ||||||||
| Payment of deferred offering costs | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash | ( | ) | ( | ) | ||||
| Cash at the beginning of the period | ||||||||
| Cash at the end of the period | $ | $ | ||||||
| Supplemental disclosures of non-cash investing and financing information: | ||||||||
| Conversion of debt to equity | $ | $ | ||||||
| Operating lease right-of-use assets obtained in exchange for operating lease liabilities | $ | $ | ||||||
| Unpaid deferred offering costs | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
PROFUSA, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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
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 March 31, 2026, the Company had a working capital deficit of approximately $
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”). Subsequent to March 31, 2026, the
Company amended the remaining borrowing capacity under the PIPE Subscription Agreement to $
5
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 $
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 2026. 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 $
On September 11, 2025, the Company received two
deficiency notices from Nasdaq for failing to maintain (i) a $
On March 11, 2026, Nasdaq notified the Company that it had not regained compliance with either the Minimum Bid Price Requirement or the MVLS Requirement by the March 10, 2026 deadline, and that its securities were therefore subject to delisting from The Nasdaq Global Market on both grounds. The Company appealed the delisting determination, and on March 19, 2026, Nasdaq notified the Company that the delisting action had been stayed pending the appeal. The Company attended its hearing before the Nasdaq Hearings Panel on April 21, 2026. The Nasdaq Hearings Panel represents an independent hearings panel of The Nasdaq Stock Market LLC that reviews, upon a company’s timely request, certain determinations by Nasdaq’s Listing Qualifications Department, including a staff delisting determination, denial of a listing application, or public reprimand letter, and may issue a decision granting continued listing relief or affirming delisting. See Note 13 for further details over the Nasdaq Hearings Panel’s decision which granted the Company a continued listing relief.
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 March 31, 2026, there continues 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.
6
Note 2 — Summary of Significant Accounting Policies
Basis of Presentation
The Company’s condensed consolidated financial statements include the accounts of Profusa and its wholly-owned subsidiary. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The financial statements include all adjustments (consisting only of normal recurring adjustments) that management believes are necessary for the fair statement of the Company’s financial information. These interim results are not necessarily indicative of results to be expected for the full fiscal year or any future interim period. The condensed consolidated balance sheet as of March 31, 2026 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. The interim condensed financial statements should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission.
Reverse Stock Split
On February 9, 2026, the Company effected a
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenue and expenses in the condensed consolidated financial statements and accompanying notes. The Company regularly assesses these estimates, including those related to accrued liabilities, valuation of the convertible notes payable and loans payable at fair value, warrants, valuation allowance for deferred tax assets, incremental borrowing rate, and valuation of stock-based awards. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations.
Segment Information
ASC 280, “Segment Reporting” (“ASC 280”), defines operating segments as components of an enterprise where discrete financial information is available that is evaluated regularly by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company operates as a single operating segment. The Company’s CODM is the chief executive officer, who has ultimate responsibility for the operating performance of the Company and the allocation of resources. The CODM uses cash flows as the primary measure to manage the business and does not segment the business for internal reporting or decision making.
7
Reclassification of Prior Period Presentation
Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassification had no impact on loss from operations, net loss, net loss per share, total assets, total liabilities, stockholders’ deficit, or cash flows.
During the three months ended March 31, 2026, the Company reclassified amounts previously presented as interest expense related to the Company’s convertible debt held at fair value to change in fair value of convertible notes in the condensed consolidated statements of operations. The Company also reclassified related party note payables from convertible notes and loans payable at fair value and promissory notes and other into convertible and promissory notes payable to related parties on the condensed consolidated balance sheets. These reclassification were not material to the condensed consolidated financial statements.
Leases
The Company determines if an arrangement is or contains a lease at inception by evaluating various factors, including if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration and other facts and circumstances. Lease classification is determined at the lease commencement date. Lease liabilities and their corresponding right-of-use (“ROU”) assets are recognized at commencement date and recorded based on the present value of lease payments over the expected lease term. The implicit rates within the Company’s operating leases are generally not determinable and therefore the Company estimates the incremental borrowing rate at the lease commencement date to determine the present value of lease payments. The determination of the incremental borrowing rate requires judgment. The Company determines the incremental borrowing rate for each lease using an estimated borrowing rate, adjusted for various factors including level of collateralization and term to align with the terms of the lease. The ROU asset also might include lease prepayments, offset by lease incentives. Certain leases include options to extend or terminate the lease. Lease terms include options to extend or terminate the lease when it is reasonably certain we will exercise that option.
The Company has made accounting policy elections to (i) not recognize ROU assets or lease liabilities for short-term leases (leases with lease terms of 12 months or less); and (ii) combine lease and non-lease components. Variable lease payments are recognized in the condensed consolidated statements of operations when incurred and include certain non-lease components, such as maintenance and other services provided by the lessor to the extent the charges are variable. The cash flow impact from the change in operating lease right-of-use asset and the operating lease liability during the three months ended March 31, 2026 is presented within the change in accrued expenses and other current liabilities on the condensed consolidated statements of cash flows.
ELOC
On July 28, 2025, the Company entered into the
ELOC Purchase Agreement and a related registration rights agreement with Ascent. Subject to the terms and conditions of the ELOC Purchase
Agreement, the Company has the right, but not the obligation, to sell up to $
The ELOC comprises a purchased put option and a forward share issuance that do not qualify for equity classification. Accordingly, the ELOC is measured at fair value, with changes between the put date and settlement date recognized in earnings. During the three months ended March 31, 2026, ELOC puts were settled within the same day, and the resulting changes in fair value were not material. Proceeds received upon the Company’s draws under the ELOC and the related share issuances are recognized in equity based on the gross proceeds received.
The Company issued warrants to purchase up to
8
Fair Value of Financial Instruments
The Company’s financial instruments consist of accounts payable, warrant liabilities, promissory notes, loans payable, convertible promissory notes and senior notes. The Company states accounts payable, promissory notes and senior notes at their carrying value, which approximates fair value due to the short time to the expected payment. See Note 3 for instruments valued under Level 3.
Ascent PIPE Notes
In connection with the Business Combination,
the Company assumed the rights and obligations under the PIPE Subscription Agreement, which provides for the issuance of Senior Secured
Convertible Promissory Notes (the “Ascent PIPE Notes”) in an aggregate principal amount of up to $
In accordance with ASC 825, the FVO is applied to all outstanding Ascent PIPE Notes as a single unit, and is irrevocable once elected. At each reporting date, the Ascent PIPE Notes are measured at fair value, with changes in fair value recognized in earnings, except for the portion attributable to instrument-specific credit risk, which is presented in other comprehensive income. During the three months ended March 31, 2026, the Company did not record any changes in fair value to other comprehensive income. As of March 31, 2026, the Ascent PIPE Notes are included in convertible notes payable and loans payable at fair value within the condensed consolidated balance sheets.
Stock-Based Compensation
Stock-based compensation expense related to stock options granted to employees and non-employees is recognized based on the grant date estimated fair values using the Black Scholes option pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Since the Company did not have sufficient historical information to develop reasonable expectations about future exercise behavior, the expected term for options issued to employees was calculated as the mean of the option vesting period and contractual term (the “Simplified Method”). The expected term for options issued to non-employees is the contractual term.
9
Recent Accounting Pronouncements
Recently issued accounting standards not yet adopted
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”). ASU 2024-03 requires disaggregated disclosure of income statement expenses for public business entities. ASU 2024-03 does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. As revised by ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, the provisions of ASU 2024-03 are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. With the exception of expanding disclosures to include more granular income statement expense categories, the Company does not expect the adoption of ASU 2024-03 to have a material effect on its condensed consolidated financial statements taken as a whole.
In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities. ASU 2025-10 established authoritative guidance for the accounting for a government grant received by a business entity, including guidance for a grant related to an asset and a grant related to income. This guidance is effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. The Company is currently evaluating the impact of the guidance on its condensed consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. ASU 2025-11 clarifies the applicability of interim reporting guidance under GAAP, provides a comprehensive list of interim disclosure requirements within Topic 270, and introduces a disclosure principle requiring entities to provide information about events and changes occurring after the end of the most recent annual reporting period that have a material impact on the entity. The ASU does not change the fundamental nature of interim reporting or expand or reduce existing interim disclosure requirements. ASU 2025-11 is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027 for public business entities, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its interim financial reporting and related disclosures.
Recently adopted accounting standards
In November 2024, the FASB issued ASU No. 2024-04, Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments. The guidance in ASU 2024-04 clarifies the requirements related to accounting for the settlement of a debt instrument as an induced conversion when changes are made to conversion features as part of an offer to settle the instrument. This ASU is effective for annual periods beginning after December 15, 2025, with early adoption permitted. The amendments may be applied either (1) prospectively to any settlements of convertible debt instruments that occur after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements, with a cumulative adjustment-effect adjustment to equity. The Company adopted ASU 2024-04 as of January 1, 2026 on a prospective basis, which did not have a material impact on the condensed consolidated financial statements.
10
Note 3 — Fair Value Measurement
Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value represents the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
| Level 1 — | Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; |
| Level 2 — | Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and |
| Level 3 — | Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. |
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The Company measures certain financial instruments at fair value using valuation techniques that require the use of observable and unobservable inputs and assumptions, including, as applicable, risk-free interest rates, expected terms, expected volatility, credit risk, market yields, conversion or exercise prices, the fair value of the Company’s common stock, and other instrument-specific terms and market inputs. The risk-free interest rate for each applicable financial instrument is based on the U.S. Treasury yield curve in effect as of the valuation date for a term commensurate with the expected term, contractual term, or estimated settlement period of the instrument, as applicable. Expected volatility, when applicable, may differ among financial instruments due to differences in expected terms, contractual maturities, settlement provisions, conversion or exercise features, valuation methodologies, market inputs, and the historical periods used to estimate volatility.
11
As of March 31, 2026 and December 31, 2025, the Company’s financial assets and liabilities measured at fair value on a recurring basis, were as follows (in thousands):
| As of March 31, 2026 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Convertible notes due to related parties held at fair value | $ | $ | $ | $ | ||||||||||||
| Loans payable at fair value | ||||||||||||||||
| Warrant liabilities - Private Placement Warrants | ||||||||||||||||
| Warrant liabilities - Representative’s Warrants | ||||||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2025 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Digital assets (Bitcoin) | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Convertible notes due to related parties held at fair value | $ | $ | $ | $ | ||||||||||||
| Loans payable at fair value | ||||||||||||||||
| Warrant liabilities - Private Placement Warrants | ||||||||||||||||
| Warrant liabilities - Representative’s Warrants | ||||||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
The key inputs into the Monte Carlo simulation model for the warrant liabilities, as affected by the Reverse Stock Split, were as follows at March 31, 2026 and December 31, 2025:
Each warrant entitles the registered holder to
purchase one seventy-fifth (1/75) of one share of our common stock at a price of $
| March 31, 2026 | December 31, 2025 | |||||||
| Input | ||||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (years) | ||||||||
| Expected volatility | % | % | ||||||
| Exercise price | $ | $ | ||||||
| Fair value of Common stock | $ | $ | ||||||
12
Warrant Liabilities
The following table provides a summary of the changes in the fair value of the Company’s Level 3 warrant liabilities that are measured at fair value on a recurring basis for the three months ended March 31, 2026 (in thousands):
| Private Placement Warrants | Representative’s Warrants | Total Level 3 Warrant liabilities | ||||||||||
| Fair value at January 1, 2026 | $ | $ | $ | |||||||||
| Gain in fair value of warrant liabilities | ( | ) | ( | ) | ( | ) | ||||||
| Fair value at March 31, 2026 | $ | $ | $ | |||||||||
Convertible notes payable, related party
The Tasly Convertible Note and the Convertible
Promissory Note - Related Party (collectively “Related Party Convertible Notes Payable”) were valued using a Probability
Weighted Expected Return Model to fair value the convertible note. The intrinsic conversion value as of March 31, 2026 was $
The following table provides a summary of the changes in the fair value of the Company’s Level 3 Related Party Convertible Notes Payable for the three months ended March 31, 2026 and 2025 (in thousands):
| Tasly Convertible Note - Related Party | Related Party Convertible Promissory Note | Total Level 3 Related Party Convertible Notes | ||||||||||
| Fair value as of January 1, 2026 | $ | $ | $ | |||||||||
| Loss on change in the fair value of related party convertible debt | ||||||||||||
| Fair value as of March 31, 2026 | $ | $ | $ | |||||||||
| Tasly Convertible Note - Related Party | ||||
| Fair value as of January 1, 2025 | $ | |||
| Loss on change in the fair value of related party convertible notes | ||||
| Fair value as of March 31, 2025 | $ | |||
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Loans Payable
The Company uses a Monte Carlo simulation model to value the Loans Payable, which represents the issued Ascent PIPE Notes. The Loans Payable were classified within Level 3 of the fair value hierarchy due to the use of unobservable inputs. Inherent in pricing models are assumptions related to expected share-price volatility, expected life and risk-free interest rate. The Company estimates the volatility of its common stock based on historical volatility that matches the expected remaining life of the loans payable. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the loans. The expected life of the loans are assumed to be equivalent to their remaining contractual term.
The key inputs into the Monte Carlo simulation model for the Loans Payable were as follows at March 31, 2026 and December 31, 2025:
| March 31, 2026 | December 31, 2025 | |||||||
| Input | ||||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (years) | ||||||||
| Expected volatility | % | % | ||||||
| Fair value of Common stock | $ | $ | ||||||
The following table provides a summary of the changes in the fair value of the Company’s Level 3 Loans Payable for the three months ended March 31, 2026 (in thousands):
| Loans Payable | ||||
| Fair value as of January 1, 2026 | $ | |||
| Repayments of debt | ( | ) | ||
| Conversion of debt to equity | ( | ) | ||
| Loss on change in the fair value of loans payable | ||||
| Fair value as of March 31, 2026 | $ | |||
The fair value of the Company’s Loans Payable settled through conversion was determined by multiplying the closing price of the Company’s common stock on the applicable conversion date by the number of shares of common stock issued upon settlement.
Loss on change in the fair value of convertible notes on the condensed consolidated statements of operations comprise of the change in fair value of the Company’s convertible notes and its related accrued interest on the convertible notes. As of March 31, 2026, the Loans Payable is due within 12 months of the balance sheet date and is therefore recorded in convertible notes payable and loans payable at fair value on the condensed consolidated balance sheets.
Digital Asset
On March 11, 2026, the Company’s management
made the determination to terminate the Company’s Bitcoin treasury reserve strategy in light of current market conditions and the
Company’s evaluation of its capital allocation priorities. During the three months ended March 31, 2026, the Company sold
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Note 4 — Balance Sheet Components
Prepaid expenses and other current assets (in thousands):
| March 31, 2026 | December 31, 2025 | |||||||
| Prepaid insurance | $ | $ | ||||||
| Prepaid expenses | ||||||||
| $ | $ | |||||||
Accrued Liabilities (in thousands):
| March 31, 2026 | December 31, 2025 | |||||||
| Accrued compensation | $ | ( | ) | $ | ( | ) | ||
| Accrued other liabilities | ( | ) | ( | ) | ||||
| $ | ( | ) | $ | ( | ) | |||
Note 5 — Debt
The following table sets forth a summary of the debt instruments and their changes during the three months ended March 31, 2026 and 2025 (in thousands):
| Loans Payable | Tasly Convertible Note - Related Party | Convertible Promissory Note - Related Party | Senior Notes | Promissory Notes | PPP Loan | D&O Insurance Financing | ||||||||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
| Debt repayments | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||
| Change in fair value | ||||||||||||||||||||||||||||
| Conversion of debt to equity | ( | ) | ||||||||||||||||||||||||||
| Debt forgiven | ( | ) | ||||||||||||||||||||||||||
| Accrued stated interest | ||||||||||||||||||||||||||||
| Balance at March 31, 2026; Current debt | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
| Accounting basis | ||||||||||||||||||||||||||||
| Interest rate | % | % | | % | | % | % | % | ||||||||||||||||||||
| Conversion price(s) per share | $ | |||||||||||||||||||||||||||
| Maturity | various | |||||||||||||||||||||||||||
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| Junior Convertible Notes | Tasly Convertible Note - Related Party | Senior Notes | Promissory Notes | PPP Loan | ||||||||||||||||
| Balance at January 1, 2025 | $ | $ | $ | $ | $ | |||||||||||||||
| Issuance of debt | ||||||||||||||||||||
| Change in fair value | ||||||||||||||||||||
| Stated interest | ||||||||||||||||||||
| Amortization of debt discount and issuance costs | ( | ) | ||||||||||||||||||
| Balance at March 31, 2025; Current debt | $ | $ | $ | $ | $ | |||||||||||||||
Convertible Notes
Loans Payable
As of March 31, 2026, the Company had issued
an aggregate principal of $
During the three months ended March 31, 2026,
the Company repaid $
The Company elected to apply the fair value option
to account for the Ascent PIPE Notes and as such, no features of the Ascent PIPE Notes are bifurcated and separately accounted for. As
of March 31, 2026, the loans payable had a fair value of $
Tasly Convertible Note - Related Party
In June 2023, the Company entered into a short-term
loan agreement with a related party for borrowings of up to $
The loans bear interest at a rate of
16
The Company elected to apply the fair value option
to account for the Tasly Convertible Note and as such, no features of the Tasly Convertible Note are bifurcated and separately accounted
for. The fair value of the Tasly Convertible Note was $
The intrinsic conversion value as of March 31,
2026 and December 31, 2025 was $
Convertible Promissory Note – Related Party
The Company now holds the convertible working
capital promissory note which was previously held by Northview Acquisition Corporation with NorthView Sponsor I, LLC, the sponsor of NorthView
(the “Sponsor”) for up to $
Junior Convertible Notes
The annual effective interest rate for the junior
convertible notes was estimated between
Senior Notes
As of March 31, 2026, the outstanding balance
of Senior Notes is less than $
17
Promissory Notes
The carrying value of the promissory notes as
of March 31, 2026 and December 31, 2025 was $
Paycheck Protection Program (“PPP”)
The Company applied for forgiveness of the 2nd
PPP Loan in December 2025 and was notified in February 2026 that the loan had been forgiven. The Company recognized a gain on the extinguishment
of the 2nd PPP Loan of $
Director and Officer (D&O) Insurance Financing
During the three months ended March 31, 2026,
the Company made aggregate payments of $
Minimum Future Payments for the Company’s Outstanding Borrowings
As of March 31, 2026, the contractual future minimum payments for the Company’s outstanding borrowing arrangements were as follows (in thousands):
| Remaining nine months of 2026 | 2027 | Total | ||||||||||
| Tasly convertible note - related party | $ | $ | $ | |||||||||
| Convertible promissory note - related party | ||||||||||||
| Loans payable | ||||||||||||
| Senior notes | ||||||||||||
| Promissory notes | ||||||||||||
| D&O financing | ||||||||||||
| Total contractual obligations | $ | $ | $ | |||||||||
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Note 6 — Commitments and Contingencies
Operating Lease Obligations
On January 27, 2026, the Company executed a 15
month lease agreement for its office and lab facilities for a total consideration of $
For the three months ended March 31, 2026, operating
lease expense and sublease income was $
For the three months ended March 31, 2025, the
Company recognized an aggregate of $
As of March 31, 2026, the operating lease
right-of-use asset of $
Contingencies and Indemnifications
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount.
Under an advisory agreement with The Benchmark
Company, LLC, the Company may be required to pay up to an additional $
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but that have not yet been made. To date, the Company has not paid any claims; however, the Company may record charges in the future as a result of these indemnification obligations.
In December 2025, the Company received a Notice
of Entry of Judgment in connection with litigation brought by a vendor with claims for breach of contract, which was ruled in favor of
the vendor. As of March 31, 2026 and December 31, 2025, the Company had accrued approximately $
In February 2026, the Company received a demand
letter from counsel for a former employee for unpaid wages of approximately $
Mayo Clinic License Agreement
On February 11, 2026, the Company entered into a know-how license agreement (the “License Agreement”), with Mayo Foundation for Medical Education and Research (“Mayo”). Pursuant to the License Agreement, Mayo granted the Company an exclusive, worldwide license, with the right to sublicense, under certain patent rights that may arise during the term of the License Agreement, and a non-exclusive, worldwide license, with the right to sublicense, to certain know-how, in each case in the fields of continuous oxygen measurement and critical limb-threatening ischemia. Mayo retains certain customary reserved rights, including rights related to educational, research and clinical programs.
19
Under the License Agreement, beginning with the first commercial sale of a licensed product, the Company is required to pay Mayo earned royalties on net sales of licensed products. The applicable royalty rates vary based on the licensed field and the type of intellectual property coverage applicable to the licensed product. The Company is also obligated to make nonrefundable milestone payments to Mayo upon the first achievement of specified commercial, regulatory and clinical events for each licensed product and to pay Mayo a percentage of certain sublicense income received by the Company. As of March 31, 2026, no commercial sales, milestone events or sublicense income had occurred under the License Agreement, and no amounts were due to Mayo.
The License Agreement contains customary provisions regarding diligence, confidentiality, use of name, representations and warranties, disclaimers, indemnification, insurance, compliance with applicable laws and termination rights. Unless earlier terminated, the License Agreement expires upon the later of the expiration of the last-to-expire licensed foreground patent right or the fifteenth anniversary of the first commercial sale of the last launched licensed product. Upon expiration of the Company’s obligation to pay earned royalties, and subject to the Company’s compliance with its obligations, the Company will have a fully paid-up license.
Note 7 - Stockholders’ Deficit
Preferred Stock
There were
Common Stock
Each share of common stock is entitled to
The Company reserved shares of common stock, as adjusted for the recapitalization and for the Reverse Stock Split, on an as-converted basis, for future issuance as follows:
| March 31, 2026 | December 31, 2025 | |||||||
| Outstanding options under 2025 Plan | ||||||||
| Issuance of options under the 2025 Plan | ||||||||
| Outstanding common stock warrants | ||||||||
| Issuance of earnout shares (1) | ||||||||
| (1) |
Note 8 - Common Stock Warrants
As of March 31, 2026 and December 31,
2025, the Company had four classes of warrants totaling
| Exercise price | Expiration date | Number of shares underlying warrants | ||||||||
| Public Warrants | $ | |||||||||
| Private Placement Warrants | $ | |||||||||
| Representative’s Warrants | $ | |||||||||
| HCW Warrants | $ | |||||||||
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Note 9 — Stock Option Plan
In 2010, Legacy Profusa adopted the 2010 Equity
Incentive Plan (the “2010 Plan”) under which
Activity under the Plan, as adjusted for the recapitalization and Reverse Stock Split is set forth below:
| Options Outstanding | ||||||||
| Stock Option Activity | Number of Options | Weighted-Average Exercise Price Per Share | ||||||
| Balances at December 31, 2025 | $ | |||||||
| Options granted | ||||||||
| Options cancelled | ( | ) | ||||||
| Balances at March 31, 2026 | $ | |||||||
Stock-Based Compensation Expense by Function
The following table is a summary of stock compensation expense by function recognized for the three months ended March 31, 2026 and 2025 (in thousands):
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| General and administrative | $ | $ | ||||||
| Research and development | ||||||||
| Total stock-based compensation | $ | $ | ||||||
Increase in stock based compensation for the three months ended March 31, 2026 is due to incremental grants issued subsequent to March 31, 2025.
21
Note 10 — Related Party Transactions
The Company has funded its operations to date
primarily through private sales of convertible preferred stock, convertible notes, loans payable and promissory notes. These investments
have included various related parties.
| Related Party | Nature of relationship | Description of investment or transaction | March 31, 2026 | December 31, 2025 | ||||||||
| Tasly | $ | $ | ||||||||||
| NVAC Sponsor I, LLC | $ | $ | ||||||||||
| The founders | $ | $ | ||||||||||
| NVAC Sponsor I, LLC | $ | $ | ||||||||||
For the three months ended March 31, 2026 and
2025, related party interest expense was $
| (1) |
| (2) |
Note 11 — Net Loss per Share Attributable to Common Stockholders
Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. In periods of net loss, the two-class method requires that losses be allocated only to common shareholders. The computation of diluted net loss per share does not include dilutive common stock equivalents in the weighted-average shares outstanding, as the inclusion of common stock equivalents would be antidilutive. The common stock equivalents consist of stock options, convertible notes and loans payable, warrants, and earn-out shares. Accordingly, for the periods presented in which the Company incurred a net loss, basic and diluted EPS are the same.
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Numerator: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Denominator: | ||||||||
| Weighted average shares used to compute basic and diluted net loss per share | ||||||||
| Net loss per share attributable to common stockholders - basic and diluted: | $ | ( | ) | $ | ( | ) | ||
22
The following outstanding shares of potentially dilutive securities, as adjusted for the recapitalization were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Convertible preferred stock | ||||||||
| Convertible notes payable | ||||||||
| Related party convertible notes payable at fair value (1) | ||||||||
| Loans payable - held at fair value (2) | ||||||||
| Warrants | ||||||||
| Options to purchase common stock | ||||||||
| Earnout shares (3) | ||||||||
| Total | ||||||||
| (1) |
| (2) |
| (3) |
Note 12 — Segments
The Company operates as
The CODM function is regularly provided with
the following significant segment expenses. Significant expenses include research and development and general and administrative expenses,
which are each separately presented in the Company’s condensed consolidated statements of operations. The CODM reviews significant
expenses within both the research and development and the general and administrative categories. Other segment items within net loss
include interest expense, loss on change in fair value of convertible notes, gain on change in fair value of warrant liabilities, loss
on disposal of digital assets, gain on extinguishment of PPP loan, financing costs and other income (expense).
23
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research personnel compensation costs, including stock-based compensation | $ | $ | ||||||
| Contract research organization and regulatory costs | ||||||||
| Administrative personnel compensation costs, including stock-based compensation | ||||||||
| Rent and office costs | ||||||||
| Legal and accounting costs | ||||||||
| Other expenses (1) | ||||||||
| Total segment expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expense): | ||||||||
| Loss on change in the fair value of convertible notes | ( | ) | ( | ) | ||||
| Gain on change in fair value of warrant liabilities | ||||||||
| Loss on disposal of digital assets | ( | ) | ||||||
| Interest expense (including related parties amounts of $ | ( | ) | ( | ) | ||||
| Gain on extinguishment of PPP loan | ||||||||
| Financing costs | ( | ) | ||||||
| Other income (expense) | ( | ) | ||||||
| Total other income (expense), net | ( | ) | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| (1) |
The Company has no significant long-lived assets recognized on the condensed consolidated balance sheets. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets.
Note 13 — Subsequent Events
The Company has evaluated its subsequent events as of March 31, 2026, through the date these condensed consolidated financial statements were issued and has determined that there are no subsequent events requiring disclosure in these condensed consolidated financial statements other than the items noted below.
During the months April and May 2026, the Company
issued
24
Related Party Convertible Promissory Note Amendments
On April 6, 2026, the Company amended the related
party convertible promissory note to update the conversion price to $
On April 24, 2026, the Company entered into a
Note Modification and Conversion Agreement with NorthView Sponsor I LLC, amending that certain Promissory Note to establish an outstanding
non-interest-bearing principal balance of $
PIPE Notes and Warrants
On April 2, 2026, the Company entered into Amendment
No. 4 to our PIPE Subscription Agreement and related Pledge Agreement with Ascent (“Amendment No. 4”). Under Amendment No.
4, the Company may request additional funding with an aggregate principal amount of up to $
Amendment No. 4 also modified certain terms of
the related Pledge Agreement, including revising the release condition to provide that the applicable release condition will be satisfied
upon payment in full, whether in cash or through conversion, of an aggregate principal amount of $
In connection with the additional closings on
April 2, 2026 and April 20, 2026, the Company issued Ascent PIPE Notes with an aggregate principal amount of $
In connection with the Ascent Warrant issuance,
the Company entered into a side letter agreement with Ascent pursuant to which Ascent waived certain defaults under the Purchase Agreement,
the number of shares issuable upon exercise of the Ascent Warrant was increased to
In connection with the Ascent Warrant issuance,
Ascent also entered into a lock-up agreement with the Company, dated as of April 20, 2026, pursuant to which Ascent agreed not to transfer
shares underlying the Ascent Warrant for
On April 29, 2026, the Company and Ascent Partners Fund LLC entered into an amendment for the Ascent Warrant, which eliminated the provisions relating to the automatic conversion or assumption of the Ascent Warrant in connection with fundamental transactions.
25
Asset Purchase Agreement
On April 1, 2026, the Company entered into a Letter of Intent (“LOI”) with Bio Insights LLC for the proposed acquisition of Bio Insight LLC’s PanOmics Assay. On April 21, 2026, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Bio Insights LLC (“Seller”), pursuant to which the Company agreed to acquire substantially all of the know-how assets related to Seller’s PanOmics Assay, an integrated NGS multi-omics analysis platform used in drug discovery and precision medicine (the “Purchased Assets”). The Purchased Assets include proprietary methodologies, data, processes, algorithms, software, databases, and related goodwill, but exclude patent rights and biological samples (which remain with Seller, subject to an exclusive sample access license granted to the Company).
The aggregate purchase price is $
The Asset Purchase Agreement contains customary representations, warranties, covenants, and indemnification provisions, including a five-year non-compete, 24-month transition assistance, and a voting agreement. The closing is subject to customary conditions, and either party may terminate if the closing has not occurred on or before September 30, 2026.
Nasdaq Letters
On April 28, 2026, Nasdaq notified the Company
that it had not regained compliance with Nasdaq Listing Rule 5450(b)(1)(C), which requires the Company to maintain a minimum market value
of publicly held shares of $
On May 6, 2026, Nasdaq notified the Company that
the Nasdaq Hearings Panel had granted the Company’s request for continued listing on Nasdaq, subject to certain conditions. The
Nasdaq Hearings Panel granted the Company an exception to cure its listing deficiencies, including noncompliance with Nasdaq Listing Rule
5550(a)(2), which requires a minimum bid price of $
On May 13, 2026, the Company received notice that it will be transferred to The Capital Market as of May 15, 2026.
26
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This discussion and analysis should be read in conjunction with our financial statements and accompanying notes included elsewhere in this report. Operating results are not necessarily indicative of results that may occur in future periods. This report includes 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 (the “Exchange Act”). We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other Securities and Exchange Commission (“SEC”) filings.
Business Overview
We are a clinical-stage digital health and medical technology company focused on developing biosensing solutions to improve health outcome for patients in a variety of different diseases and conditions. Our first product is Lumee Oxygen, which enables physicians to ascertain the extent of perfusion, or passage of blood through the circulatory system to an organ or tissue, in patients with Critical Limb Ischemia (“CLI”) both during and after endovascular revascularization procedures. Lumee Oxygen received regulatory approval in Europe through the attainment of a CE mark which subsequently lapses in 2020. The Company is working to obtain a renewed CE Mark for commercialization in Europe. In addition, prior to commercialization in the U.S., Lumee Oxygen must obtain FDA clearance or approval.
The latest version of Lumee Oxygen is called Wireless Lumee Oxygen System. It has multiple components, one of which is a microsensor that is injected into the tissue of the patient using a hypodermic needle. The sensor is designed so it does not need to be removed as it overcomes the foreign body response that usually inhibits the ability of permanent implants to function. The sensor contains no electronics, utilizing luminescence to send a light signal to a reader that is placed over the incision site, which in turn can send a signal to an app on a smartphone. We are in clinical trials for Lumee Glucose, our sensing solution being developed for use in continuous glucose monitoring (“CGM”). This system targets diabetics and pre-diabetics to allow them realtime access to their glucose data, at a price point that our management thinks is comparable or lower to existing systems.
In 2024, we started to sell our oxygen sensor for research use only applications, namely animal models and in vitro testing. Management is targeting the European market (those jurisdictions that accept CE mark) for early launch for both Lumee Oxygen and Lumee Glucose. Lumee Oxygen’s launch in Europe occurred in 2023 and Lumee Glucose launch is expected to occur in 2026, subject to regulatory approval. We have access to key opinion leaders (“KOLs”) in both Europe and the United States, who deal with peripheral arterial disease (“PAD”) and CLI.
We will sell directly to facilities based on the endorsement of these KOLs. In Germany, Austria and France, some KOLs have already used Lumee Oxygen on a trial basis. We have worked with reimbursement consultants to develop potential Category I Current Procedural Terminology (“CPT”) codes for Lumee Oxygen use. Additionally, we have entered into commercial and clinical collaboration agreements with practitioners and hospital departments in Austria, Belgium and France.
Regarding Lumee Glucose, if and when we obtain marketing authorization, we plan to embark on a dual strategy of both direct to hospital sales, for our professional-use and personal-use CGM product, and direct to pharmacy sales for our personal use product only, thereby maximizing flexibility for the consumer. By aiming for coverage under a user’s pharmacy benefit, we believe we can diversify our user base, while accounting for any risk related to unlikely delay of attainment of a category I CPT code for sensor insertion. We feel a difference between other insertable or implantable CGMs and Lumee Glucose, is that the latter can be simply inserted with a hypodermic needle and does not require a surgical implantation, similar to how pharmacists use these needles to administer flu shots and other vaccines. At the same time, physicians can still leverage existing CPT codes related to interpretation of CGM data and we have, in parallel, initiated steps for CPT codes related to our sensor insertion. We will target both public and private payors for coverage.
27
Since our launch, we have devoted significantly all of our resources to research and development, as well as all clinical study activities related but not limited to Lumee Oxygen, Lumee Glucose and prototypes for sensors of at least eight other analytes. We have also invested, on a smaller scale, in making sales of Lumee Oxygen for research- use only clients, which include entities working with animal models. Furthermore, we also performed research and development under government grants.
Significant Risks and Uncertainties
The Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.
Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company.
The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. As of March 31, 2026, the Company may be required to seek additional equity or debt financing to commercialize its products. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of, or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and results of operations.
Recent Developments
Inflation, Monetary Response, and Economic Impacts
The world economy is experiencing stubbornly high inflation, a challenge not faced for decades. Following the global financial crisis, with inflationary pressures muted, interest rates were extremely low for years and investors became accustomed to low volatility. The resulting easing of financial conditions supported economic growth, but it also contributed to a buildup of financial vulnerabilities. With inflation at multi-decade highs, monetary authorities in advanced economies are accelerating the pace of policy normalization. Policymakers have continued to tighten policy against a backdrop of rising inflation and currency pressures, albeit with notable differences across regions. Global financial conditions have tightened notably this year, leading to capital outflows. Amid heightened economic and geopolitical uncertainties, investors have aggressively pulled back from risk-taking and adjusted their investment preferences generally. Key gauges of systemic risk, such as higher dollar funding costs and counterparty credit spreads, have risen. There is a risk of a disorderly tightening of financial conditions that may be amplified by vulnerabilities built over the years.
In addition, our business, growth, financial condition or results of operations could be materially adversely affected by instability or changes in a country’s or region’s economic conditions; inflation; changes in laws or regulations or in the interpretation of existing laws or regulations, whether caused by a change in government or otherwise; increased difficulty of conducting business in a country or region due to actual or potential political or military conflict; or action by the U.S. or foreign governments that may restrict our ability to transact business in a foreign country or with certain foreign individuals or entities. A possible slowdown in global trade caused by increasing tariffs or other restrictions could decrease consumer or corporate confidence and reduce consumer, government and corporate spending in countries inside or outside the U.S., which could adversely affect our operations. Climate-related events, including extreme weather events and natural disasters and their effect on critical infrastructure in the U.S. or internationally, could have similar adverse effects on our operations, users, or third-party suppliers.
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Nasdaq Continued Listing and Reverse Stock Split
As previously disclosed, on September 11, 2025, we received written notice from the staff at Nasdaq (the “Staff”) stating that we were not in compliance with the Minimum Bid Price Requirement and the MVLS Requirement. The Staff provided us an initial compliance period of 180 calendar days, or until March 10, 2026, to regain compliance with each of the Minimum Bid Price Requirement and the MVLS Requirement.
On February 9, 2026, we effected a 1-for-75 reverse stock split of our common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock. All share and per share information has been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.
Also as previously disclosed, on October 27, 2025, we received a letter from the Staff notifying us that, for the previous 30 consecutive business days, the market value of our publicly held shares was below the Market Value Requirement. The Staff provided us with an initial period of 180 calendar days, or until April 27, 2026, to regain compliance with the Market Value Requirement.
On March 11, 2026, we were notified by Nasdaq of our continued non-compliance with both the Minimum Bid Price Requirement and the MVLS Requirement by the March 10, 2026 deadline, and that our securities were therefore subject to delisting from The Nasdaq Global Market on both grounds. We appealed the delisting determination, and attended the hearing before the Nasdaq Hearings Panel on April 21, 2026.
On April 28, 2026, Nasdaq notified us that we had not regained compliance with Nasdaq Listing Rule 5450(b)(1)(C), which requires us to maintain a minimum market value of publicly held shares of $15.0 million for continued listing on The Nasdaq Global Market (the “MVPHS Requirement”), by the applicable compliance deadline of April 27, 2026. Nasdaq further notified us that the failure to regain compliance with the MVPHS Requirement serves as an additional basis for delisting our securities from Nasdaq and that the Nasdaq Hearings Panel will consider this additional deficiency in connection with its determination regarding the our continued listing on The Nasdaq Global Market. We intend to present our views with respect to this additional deficiency to the Nasdaq Hearings Panel within the required timeframe. There can be no assurance that the Nasdaq Hearings Panel will grant our request for continued listing, that the we will regain compliance with the MVPHS Requirement within any extension period that may be granted, or that we will otherwise maintain compliance with Nasdaq’s continued listing standards.
On May 6, 2026, Nasdaq notified us that the Nasdaq Hearings Panel had granted our request for continued listing on Nasdaq, subject to certain conditions. The Nasdaq Hearings Panel granted us an exception to cure our listing deficiencies, including noncompliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5550(b)(2), which requires a minimum market value of listed securities for continued listing on The Nasdaq Capital Market. As a condition to the exception, we are required to: (i) on or before May 11, 2026, file an application with Nasdaq’s Listing Qualifications Staff to transfer our listing to The Nasdaq Capital Market; (ii) on or before June 5, 2026, obtain stockholder approval for a reverse stock split and advise the Nasdaq Hearings Panel within 24 hours if such approval is not obtained; (iii) on or before July 6, 2026, demonstrate compliance with the minimum bid price requirement; and (iv) on or before July 6, 2026, demonstrate compliance with Nasdaq’s stockholders’ equity requirement by filing a timely public disclosure describing the transactions undertaken by us to achieve compliance and demonstrate long-term compliance with the equity requirement, and by providing an indication of our equity following such transactions. The Nasdaq Hearings Panel also required us to provide prompt notification of any significant events that occur during the exception period that may affect our compliance with Nasdaq requirements. The Nasdaq Hearings Panel reserved the right to reconsider the terms of the exception based on any event, condition or circumstance that, in its opinion, would make continued listing of our securities on Nasdaq inadvisable or unwarranted. There can be no assurance that we 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 our securities on Nasdaq. On May 13, 2026, we received notice that we will be transferred to The Capital Market as of May 15, 2026.
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Mayo Clinic License Agreement
On February 11, 2026, we entered into a know-how License Agreement (the “License Agreement”) with Mayo Foundation for Medical Education and Research (“Mayo”), pursuant to which Mayo granted us an exclusive license to certain patent rights, which the parties plan to file for and obtain during the term of the License Agreement, and a non-exclusive license to specified know-how in the fields of continuous oxygen measurement and critical limb-threatening ischemia, with the right to sublicense such rights. Mayo retains customary reserved rights for educational, research and clinical programs of Mayo.
As consideration, beginning with the first commercial sale of a licensed product, we are required to pay royalties on net sales of licensed products in amounts that vary depending on the applicable field and intellectual property coverage. We are also obligated to make milestone payments upon the achievement of specified commercial, regulatory and clinical events.
In connection with the License Agreement, we will collaborate with Mayo to investigate high impact clinical applications of our technologies for new product development and commercialization.
The License Agreement contains customary provisions regarding confidentiality, representations, warranties, disclaimers and indemnifications, and termination rights. The term of the License Agreement extends for a period tied to the life of the licensed patent rights and a post-commercialization period, unless earlier terminated.
Paycheck Protection Program (“PPP”) Loan Forgiveness
We applied for loan forgiveness for the remaining PPP loan in December 2025. On February 11, 2026, we received approval for forgiveness from the Small Business Administration for the full $1.4 million principal loan balance. We recognized a gain on the extinguishment of the PPP Loan of $1.4 million within Gain on extinguishment of PPP loan during the three months ended March 31, 2026.
Sale of Digital Assets
On March 11, 2026, we made the determination to terminate our Bitcoin treasury reserve strategy in light of current market conditions and our capital allocation priorities. During the three months ended March 31, 2026, we sold 16.51 Bitcoins for an aggregate amount of $1.2 million, resulting in realized losses of $0.3 million.
Amendments on Related-party Convertible Promissory Note
On March 20, 2026, we entered into an amendment for our related-party promissory note to extend the maturity date from January 11, 2026 to December 31, 2026. On April 6, 2026, we amended the note to update the conversion price to $0.76 per share and concurrently approved the conversion of the entire outstanding principal balance of $1.9 million into 2,460,257 shares of our common stock to the holders.
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On April 24, 2026, the Company entered into a Note Modification and Conversion Agreement with NorthView Sponsor I LLC, amending that certain Promissory Note to establish an outstanding non-interest-bearing principal balance of $1.9 million, extend the maturity date to December 31, 2026, and provide the holder with the option to convert the outstanding principal into shares of the Company’s common stock. Subsequently, on April 29, 2026, the Company entered into Amendment No. 1 to the Note Modification and Conversion Agreement, adding a covenant that restricts the issuance of conversion shares in excess of 19.99% of the issued and outstanding common stock unless and until prior stockholder approval is obtained.
Amendment No. 4 on the PIPE Subscription Agreement
On April 2, 2026, we entered into Amendment No. 4 to our PIPE Subscription Agreement and related Pledge Agreement with Ascent. Under Amendment No. 4, we may request additional funding with an aggregate principal amount of up to $12.2 million, subject to the terms and conditions of the amended agreements.
Amendment No. 4 also modified certain terms of the related Pledge Agreement, including revising the release condition to provide that the applicable release condition will be satisfied upon payment in full, whether in cash or through conversion, of an aggregate principal amount of $1.7 million of notes issued in the additional closings expected to occur on or shortly after April 2, 2026. In addition, we have agreed with Ascent that any mandatory prepayment amounts received under the notes will first be applied to obligations related to such additional notes and thereafter to certain previously issued secured convertible promissory notes.
In connection with the additional closings on April 2, 2026 and April 20, 2026, we issued Ascent PIPE Notes with an aggregate principal amount of $0.6 million and $1.1 million, respectively, and a warrant to purchase 3,333,333 shares of our common stock at an initial exercise price of $0.50 per share (the “Warrant”) that is exercisable on a cash or cashless basis through April 20, 2031, and is subject to a 9.99% beneficial ownership limitation and customary anti-dilution adjustments. The notes mature on April 2, 2027 and April 20, 2027, respectively, and each bear interest at 12% per annum and is convertible into shares of our common stock, subject to the terms of the notes. The warrant contains customary terms and provisions for instruments of this nature.
In connection with the Warrant issuance, the Company entered into a side letter agreement with Ascent pursuant to which Ascent waived certain defaults under the Purchase Agreement, the number of shares issuable upon exercise of the Warrant was increased to 3,333,333 shares, and the Company agreed to provide Ascent with demand and piggyback registration rights with respect to the underlying shares.
In connection with the Warrant issuance, Ascent also entered into a lock-up agreement with the Company, dated as of April 20, 2026, pursuant to which Ascent agreed not to transfer shares underlying the Warrant for 120 days (expiring August 22, 2026), subject to customary exceptions. Any permitted transferee is required to execute a lock-up agreement on substantially similar terms.
On April 29, 2026, the Company and Ascent Partners Fund LLC entered into an amendment to an existing Warrant to Purchase Shares of common stock, which eliminated the provisions relating to the automatic conversion or assumption of the warrant in connection with Fundamental Transactions.
Subsequent to March 31, 2026 and through the date of filing, we issued 360,000 shares of our common stock in exchange for $0.4 million under the ELOC Purchase Agreement and issued 1,870,245 shares of our common stock for the settlement of $0.8 million of principal and interest on the Ascent PIPE Notes.
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Asset Acquisition
On April 1, 2026, we entered into a Letter of Intent (“LOI”) with Bio Insights LLC for the proposed acquisition of Bio Insight LLC’s PanOmics Assay. On April 21, 2026, we entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Bio Insights LLC (“Seller”), pursuant to which we agreed to acquire substantially all of the know-how assets related to Seller’s PanOmics Assay, an integrated NGS multi-omics analysis platform used in drug discovery and precision medicine (the “Purchased Assets”). The Purchased Assets include proprietary methodologies, data, processes, algorithms, software, databases, and related goodwill, but exclude patent rights and biological samples (which remain with Seller, subject to an exclusive sample access license granted to the Company).
The aggregate purchase price is $30.0 million payable through the issuance of Series A Convertible Preferred Stock (the “Preferred Stock”), convertible into common stock one year following issuance based on the closing trading price of the Company’s common stock on the date preceding closing. Issuance of the Preferred Stock and underlying conversion shares (collectively, the “Securities”) is subject to stockholder approval as required by Nasdaq Listing Rules 5635(a) and 5635(d). The Securities are subject to a five-year lock-up, with one-fourth released annually beginning on the first anniversary of issuance. Seller is also entitled to receive a royalty equal to 3% of net revenue from commercialization of the PanOmics Assay.
The Asset Purchase Agreement contains customary representations, warranties, covenants, and indemnification provisions, including a five-year non-compete, 24-month transition assistance, and a voting agreement. The closing is subject to customary conditions, and either party may terminate if the closing has not occurred on or before September 30, 2026.
Principles of Accounting and Consolidation
The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP and pursuant to applicable rules and regulations of the SEC and include all adjustments necessary for the fair presentation of our financial position as of March 31, 2026 and 2025 and the results of operations and cash flows for the periods then ended. The accompanying condensed consolidated financial statements include the accounts of Profusa Inc. and its wholly owned subsidiary, Profusa Asia Pacific Pte. Ltd (“APAC”). All intercompany balances and transactions have been eliminated in consolidation.
Components of Results of Operations
Research and Development Expenses
Research and development expenses consist primarily of personnel expenses, including salaries, benefits, and stock-based compensation, costs of consulting, supplies, depreciation and amortization and allocations of facility-related expenses. We expect our research and development expenses to increase as we increase staffing to support product development, continue our clinical trials, build prototypes, and continue to explore and develop next generation technologies.
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General and Administrative Expenses
General and administrative expenses consist of personnel expenses, including salaries, benefits, and stock-based compensation, related to executive management, finance, legal, human resource functions, and business development, contractor and professional services fees, audit and compliance expenses, insurance costs and general corporate expenses, including merger transaction costs incurred, allocated facility-related expenses and information technology costs.
Loss on Change in the Fair Value of Convertible Notes
We elected to apply the fair value option to account for (i) the convertible notes issued between June 2023 and March 2024 (the “Tasly Convertible Note”), (ii) the Ascent PIPE Notes issued during the year ended December 31, 2025 and (iii) the Northview Sponsor working capital promissory note. Loss on change in the fair value of convertible notes comprise of the change in fair value of the Company’s convertible notes and its related accrued interest on the convertible notes. These abovementioned notes were recorded at fair value at inception and are subject to remeasurement to fair value at each balance sheet date, with the change in fair value reflected in our condensed consolidated statements of operations.
Gain on Change in Fair Value of Warrant Liabilities
The change in fair value of our private and representatives warrant liabilities that we acquired as a result of our Business Combination is reflected in this financial statement line item.
Loss on Disposal of Digital Assets
The change in fair value of Bitcoins that we held during the respective periods is reflected in this financial statement line item.
Interest Expense
Interest expense consists primarily of the interest on our senior notes, promissory notes, and PPP Loans.
Gain on Extinguishment of PPP Loan
The gain on the extinguishment of our PPP loan is reflected in this financial statement line item.
Financing Costs
Financing costs consists of costs in relation to the issuance of shares under the ELOC Purchase Agreement.
Other Income (Expense)
Other income (expense) consists primarily of interest income earned from our operating cash account and a short-term sublease of a portion of our facilities.
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Results of Operations
Comparison of the three months ended March 31, 2026 and 2025
The following table sets forth our condensed consolidated statements of operations for the periods indicated (in thousands):
| Three Months Ended March 31, | Change | |||||||||||||||
| 2026 | 2025 | $ | % | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,146 | $ | 434 | $ | 712 | 164 | % | ||||||||
| General and administrative | 2,860 | 990 | 1,870 | 189 | % | |||||||||||
| Total operating expenses | 4,006 | 1,424 | 2,582 | 181 | % | |||||||||||
| Loss from operations | (4,006 | ) | (1,424 | ) | (2,582 | ) | 181 | % | ||||||||
| Other income (expenses) | ||||||||||||||||
| Loss on change in the fair value of convertible notes | (797 | ) | (156 | ) | (641 | ) | 411 | % | ||||||||
| Gain on change in fair value of warrant liabilities | 258 | — | 258 | 100 | % | |||||||||||
| Loss on disposal of digital assets | (295 | ) | — | (295 | ) | 100 | % | |||||||||
| Interest expense (including related parties amounts of $5 and $609 for the three months ended March 31, 2026 and 2025, respectively) | (18 | ) | (1,135 | ) | 1,117 | (98 | )% | |||||||||
| Gain on extinguishment of PPP loan | 1,391 | — | 1,391 | 100 | % | |||||||||||
| Financing costs | (60 | ) | — | (60 | ) | 100 | % | |||||||||
| Other income (expense) | 71 | (1 | ) | 72 | (7200 | )% | ||||||||||
| Total other income (expense), net | 550 | (1,292 | ) | 1,842 | (143 | )% | ||||||||||
| Net loss | $ | (3,456 | ) | $ | (2,716 | ) | $ | (740 | ) | 27 | % | |||||
Research and Development – Research and development expenses increased by $0.7 million, or 164%, to $1.1 million during the three months ended March 31, 2026 from $0.4 million during the three months ended March 31, 2025. The increase was driven primarily by the increase in regulatory and contract research organization (“CRO”) costs of $0.6 million and third-party consultant services of $0.1 million, respectively, which is in line with our focus on research and development to complete device functionality and reach the point of commercialization in the near future.
General and Administrative – General and administrative expenses increased by $1.9 million, or 189%, to $2.9 million during the three months ended March 31, 2026 from $1.0 million during the three months ended March 31, 2025. The increase was driven primarily by an increase in legal, accounting and other third party professional services of $1.1 million, personnel costs of $0.4 million, and an increase to insurance fees of $0.3 million.
Loss on Change in the Fair Value of Convertible Notes – Loss on change in the fair value of convertible notes increased by $0.6 million, or 411%, to $0.8 million during the three months ended March 31, 2026 from a loss of $0.2 million during the three months ended March 31, 2025. The loss recognized during the three months ended March 31, 2026 was driven by the losses on the remeasurement of the Ascent PIPE Notes of approximately $0.6 million. During the three months ended March 31, 2025, the entirety of the loss on change in the fair value of convertible notes was due to the remeasurement of the Tasly Convertible Note.
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Gain on Change in Fair Value of Warrant Liabilities – Gain on change in the fair value of warrant liabilities was $0.3 million during the three months ended March 31, 2026 due to the decline in our stock price during the same period. We acquired the warrant liabilities as a result of the Business Combination and therefore the change in fair value of warrant liabilities is only reflected in the three months ended March 31, 2026.
Loss on Disposal of Digital Assets – Loss on disposal of digital assets was $0.3 million during the three months ended March 31, 2026. We did not have any Bitcoin during the three months ended March 31, 2025.
Interest Expense – Interest expense decreased by $1.1 million, or 98%, to $18 thousand during the three months ended March 31, 2026, from $1.1 million during the three months ended March 31, 2025. The decrease was primarily due to the conversion of the entirety of our junior convertible debt and a significant portion of our senior notes at the closing of our Business Combination.
Gain on extinguishment of PPP loan – Gain on extinguishment of PPP loan increased by $1.4 million, or 100%, due to the forgiveness of our PPP loan of $1.4 million in the three months ended March 31, 2026.
Financing Costs – Increased by $0.1 million in relation to the issuance of shares under the ELOC Purchase Agreement during the three months ended March 31, 2026.
Other Income (Expense) – Other income (expense) increased by $72 thousand during the three months ended March 31, 2026 primarily due to sublease income recognized in the period.
Liquidity and Capital Resources
Sources of Liquidity
Since inception, we have incurred recurring annual losses from operations, and we expect to continue to incur losses and negative operating cash flows for the foreseeable future until we successfully commence sustainable commercial operations. For the three months ended March 31, 2026 and 2025, we incurred a net loss of $3.5 million and $2.7 million, respectively. During the three months ended March 31, 2026 and 2025, we have used $2.6 million and $0.5 million, respectively, of cash in our operating activities. We have $12.5 million of notes, loans payable and interest due within twelve months from March 31, 2026.
We have been able to finance our operations primarily with the proceeds from the issuance of equity and debt instruments. For the three months ended March 31, 2026, we obtained net cash from financing activities of $28.0 thousand, compared to $0.4 million for the same period during 2025. We held cash of $0.4 million and $1.8 million as of March 31, 2026 and December 31, 2025, respectively. Additional funds may be necessary to maintain current operations and will be required for successful product commercialization efforts. Conditions exist that raise substantial doubt about our ability to continue as a going concern within one year from the date the condensed consolidated financial statements as of and for the three months ended March 31, 2026 are issued.
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Our 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. We have reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, cash requirements for the upcoming year, funding capacity, net working capital, total stockholders’ deficit and future access to capital.
It is our expectation to continue to make substantial investments in building our European and United States commercial infrastructure and enhancing existing products and developing new ones. Furthermore, we aim to continue discussions with potential partners in Asia.
We expect that we will require additional financing to fund our operations and planned growth. We may seek to raise any additional capital through equity offerings or debt financings, additional credit or loan facilities or a combination of one or more of these funding sources. In the scenario that we are unable to acquire sufficient financing or financing on terms satisfactory to our management or Board of Directors, our ability to continue to pursue our business objectives and to respond to business opportunities, challenges or unforeseen circumstances could be significantly limited, and our business, financial condition and results of operations could be materially adversely affected. For the current period and for twelve months following the issuance of these financial statements, our risk of going concern has been mitigated but not fully alleviated by the issuance of additional Ascent PIPE Notes with an aggregate principal amount of $1.7 million subsequent to the balance sheet date, remaining borrowing capacity on the PIPE Subscription Agreement and remaining funds available under the ELOC. As of and for the three months ended March 31, 2026, there continue to be factors which raise substantial doubt about our ability to continue as a going concern.
Long-Term Liquidity Requirements
We expect our cash on hand, remaining borrowing capacity from the PIPE Investment, proceeds from the ELOC and Ascent PIPE Notes will provide sufficient funding to support initial commercial operations. Until we generate sufficient operating cash flow to cover our operating expenses, working capital needs and planned capital expenditures, or if circumstances evolve differently than anticipated, we expect to utilize a combination of equity and debt financing to fund any future capital needs. If we raise funds by issuing equity securities, dilution to stockholders may result. Any equity securities issued may also provide for rights, preferences, or privileges senior to those of holders of common stock. If we raise funds by issuing debt securities, these debt securities may have rights, preferences, and privileges senior to those of common stockholders. The terms of debt securities or borrowings could impose significant restrictions on our operations. The capital markets are currently experiencing, and may continue to experience in the future, periods of upheaval that could impact the availability and cost of equity and debt financing.
Our principal uses of cash in recent periods have been funding our research and development activities, legal and bank transaction fees, and other personnel cost. Near-term capital requirements through March 31, 2027 leading to and supporting initial commercialization are estimated to total approximately $15.9 million and include further research and development to enable us to obtain the required regulatory approvals, manufacturing, commercialization and wide-scale marketing for our Lumee Oxygen and Lumee Glucose devices. Our future capital requirements will depend on many factors, including our revenue growth rate, the timing and the amount of cash received from our customers, the expansion of sales and marketing activities, the timing and extent of spending to support development efforts. In the future, we may enter into arrangements to acquire or invest in complementary businesses, products, and technologies. For any periods after the twelve months subsequent to the filing of these financial statements as of March 31, 2026, we may be required to seek additional equity or debt financing. In the event that we require additional financing, we may not be able to raise such financing on acceptable terms or at all. If we are unable to raise additional capital or generate cash flows necessary to continue our research and development and invest in continued innovation, we may not be able to compete successfully, which would harm our business, results of operations, and financial condition. If adequate funds are not available, we may need to reconsider our production investments, the pace of our production ramp-up, expansion plans or limit our research and development activities, which could have a material adverse impact on our business prospects and results of operations.
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Cash Flow Summary
The following table summarizes our cash flows for the periods presented (in thousands):
| Three months ended March 31, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Net cash provided by (used in): | ||||||||||||
| Operating activities | $ | (2,576 | ) | $ | (537 | ) | $ | (2,039 | ) | |||
| Investing activities | 1,145 | — | 1,145 | |||||||||
| Financing activities | 28 | 365 | (337 | ) | ||||||||
| Net decrease in cash | $ | (1,403 | ) | $ | (172 | ) | $ | (1,231 | ) | |||
Operating Activities
Cash used in operating activities for the three months ended March 31, 2026 of $2.6 million was primarily driven by our net loss of $3.5 million, adjusted for non-cash charges of $0.4 million and net cash inflows of $1.2 million provided by changes in our operating assets and liabilities. Non-cash charges primarily consisted of non-cash gain on extinguishment of our PPP loan of $(1.4) million, loss on fair value of convertible notes of $0.8 million, stock-based compensation of $0.2 million, the loss on the disposal of digital assets of $0.3 million, offset by the gain on fair value of warrant liabilities of $(0.3) million. The main driver of the cash inflows from the changes in operating assets and liabilities was primarily related to an increase in accounts payable of $1.0 million and a decrease in prepaid expenses and other current assets of $0.3 million.
Investing Activities
Cash provided by investing activities was $1.1 million for the three months ended March 31, 2026 due to the sale of our Bitcoins. We did not have any investing activities in the three months ended March 31, 2025.
Financing Activities
Cash provided by financing activities was not material for the three months ended March 31, 2026, which consisted primarily of proceeds from the issuance of ELOC of $0.5 million, offset by the repayment of borrowings of $(0.4) million.
Cash provided by financing activities was $0.4 million for the three months ended March 31, 2025, which consisted primarily of proceeds from the issuance of senior notes of $0.8 million, offset by payment of deferred offering costs of $(0.4) million.
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Contractual Obligations
The following table summarizes our contractual obligations as of March 31, 2026, and the years in which these obligations are due (in thousands):
| Remaining nine months of 2026 | 2027 | Total | ||||||||||
| Tasly convertible note - related party | $ | 2,532 | $ | — | $ | 2,532 | ||||||
| Convertible promissory note - related party | 1,870 | — | 1,870 | |||||||||
| Loans payable | — | 6,977 | 6,977 | |||||||||
| Senior notes | 43 | — | 43 | |||||||||
| Promissory notes | 1,040 | — | 1,040 | |||||||||
| D&O financing | 75 | — | 75 | |||||||||
| Total contractual obligations | $ | 5,560 | $ | 6,977 | $ | 12,537 | ||||||
Critical Accounting Estimates
The accounting policies that we consider to be our most critical, that require our most subjective or complex judgments, are summarized in “Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” in our Annual Report on the Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on April 15, 2026. There have been no material changes to our critical accounting policies and significant estimates in the three months ended March 31, 2026.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Disclosure controls are procedures that are designed with the objective of ensuring that information required to be disclosed in our reports filed under the Exchange Act, such as this Report, is recorded, processed, summarized, and reported within the time period specified in the SEC’s rules and forms. Disclosure controls are also designed with the objective of ensuring that such information is accumulated and communicated to our management, including the chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management evaluated, with the participation of our principal executive officer and principal financial officer (our “Certifying Officers”), the effectiveness of our disclosure controls and procedures as of March 31, 2026, pursuant to Rule 13a-15(b) under the Exchange Act. Based upon that evaluation, our Certifying Officers concluded that, as of March 31, 2026, our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting described below. As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, we identified material weaknesses in our internal control over financial reporting. As of March 31, 2026, these material weaknesses have not been remediated.
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We do not expect that our disclosure controls and procedures will prevent all errors and all instances of fraud. Disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Further, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and the benefits must be considered relative to their costs. Because of the inherent limitations in all disclosure controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that we have detected all our control deficiencies and instances of fraud, if any. The design of disclosure controls and procedures also is based partly on 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.
Management’s Report on Internal Controls Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or because the degree of compliance with policies or procedures may deteriorate.
Under the supervision and with the participation of our management, including our Certifying Officers, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of March 31, 2026, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Based on that evaluation, our Certifying Officers have concluded that, as of March 31, 2026, our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting described below:
(i) segregation of duties in the financial statement close process,
(ii) lack of review controls and expertise to ensure accurate valuations and accounting of financial instruments, and
(iii) lack of technical accounting expertise and internal controls to ensure accurate preparation of its financial statements in accordance with GAAP including complex debt and equity instruments.
Changes in Internal Controls over Financial Reporting
There have been no changes in our internal controls over financial reporting that occurred during the three months ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, or are reasonably likely to materially affect, our internal controls over financial reporting, other than as described above.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any material legal proceedings.
Item 1A. Risk Factors.
There have been no material changes from the risk factors previously discussed in “Part I, Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (File No. 001-41177) filed with the SEC on April 15, 2026 and in the section titled “Risk Factors” in the Company’s Registration Statement on Form S-1 (File No. 333-295364) effective as of May 4, 2026.
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.
Item 5. Other Information.
During the period covered by this Quarterly Report,
none of the Company’s directors or executive officers have
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Item 6. Exhibits
EXHIBIT INDEX
| * | Filed herewith. |
| ** | Furnished herewith |
| # | Portions of the exhibit have been excluded because it is both not material and is the type of information that the registrant treats as private or confidential. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| PROFUSA, INC. | ||
| Date: May 15, 2026 | By: | /s/ Ben Hwang |
| Name: | Ben Hwang | |
| Title: | Chief Executive Officer | |
| Date: May 15, 2026 | By: | /s/ Fred Knechtel |
| Name: | Fred Knechtel | |
| Title: | Chief Financial Officer | |
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Exhibit 31.1
CERTIFICATION
PURSUANT TO RULE 13a-14 AND 15d-14
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Ben Hwang, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Profusa, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting. |
| Date: May 15, 2026 | By: | /s/ Ben Hwang |
| Ben Hwang | ||
| Chief
Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
PURSUANT TO RULE 13a-14 AND 15d-14
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Fred Knechtel, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Profusa, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting. |
| Date: May 15, 2026 | By: | /s/ Fred Knechtel |
| Fred Knechtel | ||
| Chief
Financial Officer (Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. 1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the Quarterly Report of Profusa, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ben Hwang, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 15, 2026
| /s/ Ben Hwang | ||
| Name: | Ben Hwang | |
| Title: | Chief
Executive Officer (Principal Executive Officer) | |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. 1350
(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)
In connection with the Quarterly Report of Profusa, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Fred Knechtel, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 15, 2026
| /s/ Fred Knechtel | ||
| Name: | Fred Knechtel | |
| Title: | Chief
Financial Officer (Principal Financial and Accounting Officer) | |