Picard Medical, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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Sep 30, 2025 · Filed Nov 14, 2025
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Notes to Financial Statements (Unaudited)
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| 1. | DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION AND MANAGEMENT’S PLAN |
Description of Business
Picard Systems, Inc. was originally incorporated in the state of Delaware on* April8,* 2021, for the purpose of investing in and acquiring medical device companies, including SynCardia Systems, LLC (“SynCardia”) and its fully consolidated subsidiary SynCardia Systems Europe, GmbH (“SynCardia GmbH”). On* September27,* 2021, Picard Systems, Inc. acquired all of the authorized and outstanding membership units of SynCardia and it changed its name to Picard Medical, Inc. (“PMI”, or collectively, the “Company”).
The Company is engaged in the business of designing, manufacturing, production, supply, marketing, and sale of medical device products, including the SynCardia total artificial heart for patients (“SynCardia TAH”). The SynCardia TAH is an implantable system designed to assume the full function of a failed human heart in patients suffering from advanced heart failure. SynCardia hasone operating subsidiary, SynCardia GmbH, which was formed to facilitate the sale and distribution of SynCardia’s products throughout Europe.
Basis of Presentation and Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) applicable to interim financial statements. These consolidated financial statements should be read in conjunction with the audited financial statements for the year ended* December 31, 2024*, and the related notes which provide a more complete discussion of the Company’s accounting policies and certain other information. The* December 31, 2024*, condensed consolidated balance sheet was derived from the Company’s audited financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s condensed consolidated financial position as of* September 30, 2025*, and its results of operations, changes in temporary equity and stockholders’ equity (deficit) and cash flows for thenine months ended* September 30, 2025and2024*. The results of operations for thenine months ended* September 30, 2025*, arenot necessarily indicative of the results to be expected for the year ending* December 31, 2025*, or for any other future annual or interim period.
The consolidated financial statements include the financial statements of PMI and its subsidiaries. All intercompany transactions and account balances between PMI and its subsidiaries have been eliminated in consolidation.
On* July3,* 2025, the Company completed a1 for 2.2 forward stock split of the Company’s common stock and on* July11,* 2025, the Company completed a 1.0221 for1 reverse stock split of the Company’s common stock, resulting in an overall forward stock split of1 for 2.1524. All share and per share amounts in the financial statements have been retrospectively adjusted for all periods presented to reflect the stock split. The Company’s authorized common stock has also been increased from 45,000,000 to 150,000,000 as a result of the stock split.
Going Concern, Liquidity and Management’s Plans
The Company has evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern for at leasttwelve months from the date of this report, and the near term thereafter. The Company has incurred operating losses and negative cash flows from operations for thenine months ended* September 30, 2025*, and SynCardia has a history of operating losses dating back to its inception. The Company expects that operating losses and negative cash flows from operations will continue into the foreseeable future, and the Company will need to raise additional debt and/or equity financing to fund operations until it generates positive cash flows from operations.
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| 1. | DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION AND MANAGEMENT’S PLAN (cont.) |
To date, the Company’s available liquidity and operations have been financed primarily through the issuance of common stock, preferred stock, and debt. For the year ended* December 31, 2024*, the Company raised $11.8 million, net of repayments from the issuance of debt. For thenine months ended* September 30, 2025*, the Company raised $3.7 million, net of repayments, from the issuance of debt and $17.4 million of net proceeds from the issuance of common stock. In order to proceed with the Company’s business plan, the Company will need to raise additional funds through the issuance of additional debt, equity, or other commercial arrangements, which* may**not* be available to the Company when needed or on terms that the Company deems to be favorable. To the extent the Company raises additional capital through the sale of equity, the ownership interest of its current shareholders will be diluted, and the terms of these securities* mayinclude liquidation or other preferences that adversely affect the rights of common shareholders. Debt financing and preferred equity financing, if available, mayinvolve agreements that include covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends. If the Company is unable to obtain sufficient financial resources, its business, financial condition, and results of operations maybe materially and adversely affected. The Company maybe required to delay, limit, reduce or terminate parts of its strategic business plan or future commercialization efforts. There can beno* assurance the Company will be able to obtain financing on acceptable terms. Therefore, based on the Company’s current financial condition and expected future cash flows, there is substantial doubt about the Company’s ability to continue as a going concern for at leasttwelve months from the date of these financial statements issued. The financial statements donot include any adjustments to the carrying amounts and classification of assets, liabilities and reported expenses that* may*be necessary if the Company is unable to continue as a going concern.
| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the financial statements and accompanying notes. These estimates are based on information available through the date of the issuance of the financial statements and actual results and outcomes could differ from these estimates and assumptions. Areas requiring significant estimates and assumptions by the Company include, but arenot limited to:
| ● | Provisions for income taxes and related valuation allowances and tax uncertainties; |
| ● | Recoverability of long-lived assets and their related estimated useful lives; |
| ● | Accruals for estimated liabilities; |
| ● | Valuation of inventory; |
| ● | Valuation of leased assets; |
| ● | Valuation of stock-based compensation; |
| ● | Valuation of embedded derivative liability; and |
| ● | Valuation of common and preferred stock. |
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
Foreign Currency Translation
The functional currency of the Company’s subsidiaries in Germany and Australia is their respective local currency. Assets and liabilities are translated into U.S. dollars, the reporting currency, at the exchange rate on the balance sheet date. Revenues and expenses are translated into U.S. dollars at the average rates of exchange prevailing during each reporting period. Foreign currency translation adjustments resulting from this process are reported as an element of other comprehensive income (loss), net of income taxes, on the consolidated statements of operations and comprehensive loss. Transactions executed in different currencies are translated at spot rates and resulting foreign exchange transaction gains and losses are charged to income.
Cash and Cash Equivalents
The Company considers all highly liquid debt investments with a remaining maturity of90 days or less when purchased to be cash and cash equivalents. The Company places its cash in commercial banks. Accounts in the United States are secured by the Federal Deposit Insurance Corporation (“FDIC”) up to*$250,000.* From time to time, the Company’s total deposits at commercial banks exceed the balances insured. The Company hasnot experienced any losses in these accounts and believes it isnot exposed to any significant credit risk in this area.
Financial Instruments and Concentrations of Credit and Business Risk
Financial instruments that potentially subject the Company to a concentration of credit risk principally consist of cash, cash equivalents and accounts receivable.
Fair Value of Financial Instruments
Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, accounts receivable, notes receivable, accounts payable, notes payable, derivative liabilities and accrued liabilities.
Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance also establishes athree-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity.
Thethree-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:
Level1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level2 — 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 arenot 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
Level3 — Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little orno market data.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
Embedded Derivatives
The Company reviews the terms of debt and equity financing transactions to identify whether there are any embedded derivatives that require separation from the related host financial instrument. Any such derivatives are presented at fair value in the consolidated balance sheets, with changes in fair value recorded in other income and (expense) in the consolidated statements of operations and comprehensive loss. The Company separates an embedded provision in a debt or equity contract in which (i) the economic characteristics and risks of the embedded provision arenot clearly and closely related to the economic characteristics and risks of the host instrument, (ii) the host instrument itself isnot carried at fair value in the consolidated balance sheets, and (iii) the embedded provision would meet the definition of a derivative financial instrument. The Company has identified embedded derivatives that require bifurcation from its host instrument, namely the Convertible Notes (see also Notes3 and8).
Accounts Receivable and Allowance for Credit Losses
The Company’s accounts receivable represent amounts considered to be collectible that are owed by its customers. Credit is extended based on evaluation of customers’ financial condition and, generally, collateral isnot required. An allowance for credit losses is maintained for estimated losses resulting from the inability of customers to pay. All accounts receivable are reviewed on an account-by-account basis to assess collectability. After exhausting all collection efforts on past due accounts, an account is written off against the allowance for credit losses. Any collections on accounts previously written off are recorded as income in the period of collection. The Company hasnot recorded an allowance against its receivables based on management’s estimate that the balances recorded in all periods presented are fully collectible.
Inventory, net
Inventory is stated at the lower of cost, determined using thefirst in,first out basis, or net realizable value. Inventory consists primarily of raw material components used in the manufacturing of SynCardia TAHs and related equipment as well as work-in-process inventory related primarily to SynCardia TAHs. Finished goods consist primarily of SynCardia TAHs and related equipment located at medical centers trained and certified in the implantation of the SynCardia TAH and appropriate patient aftercare (“Centers”). Work-in-process and finished goods include the cost of all direct material, labor, and overhead costs. Inventory write-downs are recorded based on excess and obsolete exposures, determined primarily by future demand forecasts. These write-downs are measured as the difference between the cost of the inventory and net realizable value based upon assumptions about future demand and charged to the provision for inventory, which is a component of cost of sales. In addition, a liability is recorded for firm, noncancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities that exceed forecasts of future demand. As of* September 30, 2025*, the Company hadno unconditional and noncancelable purchase commitments.
Property and Equipment
Property and equipment are recorded at cost, net of accumulated depreciation. Improvements, renewals, and extraordinary repairs that materially extend the useful life of the asset are capitalized; other repairs and maintenance charges are expensed as incurred.
Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Depreciation begins at the time the asset is placed in service. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operating expenses in the period realized.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
The useful lives of the property and equipment are as follows:
| TAH-Driver equipment (years) | 3 - 5 |
|---|---|
| Laboratory equipment (years) | 2 - 10 |
| Office and computer equipment (years) | 5 |
| Leasehold improvements | Shorter of remaining lease term or estimated useful life |
Intangible Assets, net
Intangible assets comprise developed technology and trade name. Intangible assets are carried at cost less accumulated amortization. Amortization is computed using the straight-line method over useful lives oftwelve years for developed technology andfive years for trade name.
Goodwill
Goodwill is subject to an annual impairment test, or earlier if indicators of potential impairment exist. The annual impairment test is performed as of* December**31* of each year. The Company has the option to perform a qualitative assessment by examining relevant events and circumstances which could have a negative impact on goodwill, including macroeconomic conditions, industry and market conditions, cost factors, overall financial performance, and other relevant events specific to the Company. If, after assessing the totality of events or circumstances described above, the Company determines that it is more likely thannot that a reporting unit’s fair value is less than its carrying value, the Company will perform a quantitative impairment test. Upon performing the quantitative impairment test, if the fair value of the reporting unit is less than its carrying amount, goodwill is impaired and the excess of the reporting unit’s carrying value over the fair value is recognized as an impairment loss; however, the loss recognized wouldnot exceed the total amount of goodwill allocated to that reporting unit. For the purpose of completing its impairment test, the Company performs either a qualitative or a quantitative analysis on a reporting unit basis. All of the goodwill is expected to be deductible for income tax purposes.
Quantitative impairment tests consider both the income approach and the market approach to estimate a reporting unit’s fair value. The income and market valuation approaches consider a number of factors that include, but arenot limited to, prospective financial information, growth rates, residual values, discount rates and comparable multiples from publicly traded companies in the Company’s industry and require it to make certain assumptions and estimates regarding industry economic factors and the future profitability of the business. As of* September 30, 2025* and* December 31, 2024*, the Company has assessedno impairment of goodwill.
Impairment of Long-Lived Assets
The Company evaluates long-lived assets, primarily property and equipment, right-of-use lease assets, developed technology and trade name, for impairment on an annual basis, or whenever events or changes in circumstances indicate that the carrying amount of an asset* may**not* be recoverable. When the Company determines that it is probable that undiscounted future cash flows willnot be sufficient to recover an asset’s carrying amount, the asset is written down to its fair value. Assets to be disposed of by sale, if any, are reported at the lower of the carrying amount or fair value less cost to sell. As of* September 30, 2025* and* December 31, 2024*, the Company has assessedno impairment of its long-lived assets.
Revenue Recognition
The Company generates revenue from the sale of its SynCardia TAH, rental of Freedom drivers, and from training and certification services, which are required before thefirst time a transplant center* may*purchase a SynCardia TAH. Revenue includes sales and services to Centers located in the United States as well as Centers domiciled in foreign countries.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
The Company recognizes revenue when it transfers control of promised goods or services to its customers, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition, the Company performs the followingfive steps:
| (i) | identification of the promised goods or services in the contract; |
| (ii) | determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; |
| (iii) | measurement of the transaction price, including the constraint on variable consideration; |
| (iv) | allocation of the transaction price to the performance obligations based on estimated selling prices; and |
| (v) | recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account. |
Product Revenues
The Company recognizes revenue when performance obligations identified under the terms of contracts with its customers are satisfied, which generally occurs, for SynCardia TAH kits, upon the transfer of control in accordance with the contractual terms and conditions of the sale. The majority of the Company’s revenue associated with SynCardia TAH kits are recognized at a point in time when the SynCardia TAH kit is shipped to the customer. The Company only offers assurance-type standard warranties that donot represent separate performance obligations. The Company records amounts billed to customers for reimbursement of shipping and handling costs within revenue. Shipping and handling costs associated with outbound freight after control over a SynCardia TAH kit has transferred to a customer are accounted for as fulfillment costs and are included in cost of revenues. Sales taxes and other usage-based taxes are excluded from revenue. The Company gives certain discounts to product distributors based on a contracted amount on the sale of its products. Discounts applied to invoices arenot associated with future purchases and solely relate to the product invoiced. As a result, the invoice and transaction price are recorded net of any discounts. The amount of consideration to which the entity will be entitled in exchange for transferring the promised goods or services to a customer is estimated using the expected value method. Product revenue is billed at the point of sale upon shipment and typically collected within30 days.
Rental Revenues
Rental revenues primarily consist of rental fees charged to customers who rent the Company’s driver. Rental revenue is earned over the period of usage which begins when a patient is discharged from a hospital and is recognized when it becomes likely that we will receive payment. Rental revenue is billed at month end and typically collected within30 days.
Professional Services Revenues
Professional services revenues primarily consist of training and certification services. The Company’s professional services revenue is recognized when the services are performed. Professional services revenue is billed upon completion of services and typically collected within30 days.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
Contracts with Multiple Performance Obligations
From time to time, the Company has contracts with customers that contain multiple performance obligations. For these contracts, the Company accounts for individual performance obligations separately if they are distinct. The Company accounts for individual goods and services separately if they are distinct performance obligations, which often requires significant judgment based upon knowledge of the products and/or services, the solution provided and the structure of the sales contract. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis for those performance obligations with stable observable prices. The Company determines the standalone selling prices based on its overall pricing objectives, taking into consideration market conditions and other factors, including the value of the contracts, pricing when certain services are sold on a standalone basis, the products sold, customer demographics, geographic locations, and the volume of services purchased. As of* September 30, 2025* and* December 31, 2024*, there wereno unsatisfied performance obligations associated with its customer contracts.
Returns
The Company doesnot offer rights of return for its products and services in the normal course of business.
Contract Balances
The Company’s contract liabilities, if any, consist of advance payments for systems as well as deferred revenue on service obligations (see Note5). As of* September 30, 2025* and* December 31, 2024*, there wasno amount of deferred revenue recorded on the Company’s consolidated balance sheets, respectively.
Practical Expedients
The Company applies a practical expedient to expense costs as incurred for costs to obtain a contract when the amortization period would have beenone year or less. These costs are recorded within selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Payment Terms
Payment terms vary by customer but typically provide for the customer to pay within30 days. Therefore, customer payment terms are for12 months or less and donot include significant financing components. The Company performs credit evaluations of customers and evaluates the need for allowances for potential credit losses based on historical experience, as well as current and expected general economic conditions.
Cost of revenues
Cost of revenues includes product costs, labor, overhead, inbound freight, and other product-related costs including maintenance costs, excess inventory, and obsolescence charges.
Shipping and Handling Fees and Costs
The Company includes shipping and handling fees billed to customers as part of net sales and shipping and handling costs associated with the outbound freight are included in cost of sales.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
Research and Development Costs
Included in research and development costs are wages, stock-based compensation and benefits of employees performing research and development, and other operational costs related to the Company’s research and development activities, including facility-related expenses, allocation of corporate costs, and external costs of outside contractors.
Comprehensive Income (Loss)
Comprehensive income (loss) consists of net income (loss), and foreign currency translation adjustments, net of tax, which are recorded within other comprehensive income (loss).
Income Taxes
The Company calculates its provision for income tax on the basis of the tax laws enacted at the balance sheet date. The Company uses an asset and liability approach for financial accounting and reporting for income taxes that allows recognition and measurement of deferred tax assets based upon the likelihood of realization of tax benefits in future years. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. Under the asset and liability approach, deferred taxes are provided for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A valuation allowance is provided for deferred tax assets if it is more likely thannot these items will either expire before the Company is able to realize their benefits, or that future deductibility is uncertain. The Company records unrecognized tax benefits, where appropriate, for all uncertain income tax positions. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period, without consideration of potential common shares.
Diluted net loss per share is calculated by dividing net loss available to common stockholders by the weighted average number of common shares outstanding plus common share equivalents from conversion of dilutive stock options using the treasury method and Series A-1 Preferred Stock and Convertible Notes using the as-converted method, except when antidilutive. In the event of a net loss, the effects of all potentially dilutive shares are excluded from the diluted net loss per share calculation as their inclusion would be antidilutive.
Stock-Based Compensation
The Company measures the fair value of all stock-based awards, including stock options, on the grant date and records the fair value of these awards to compensation expense over the service period. The Company has elected to account for forfeitures as they occur. The fair value of stock option awards is estimated using the Black-Scholes valuation model, which considers several variables and assumptions in estimating the fair value of stock-based awards. These assumptions include:
| ● | per share fair value of the underlying common stock; |
| ● | risk-free interest rate; |
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
| ● | expected term; |
| ● | expected stock price volatility over the expected term; and |
| ● | expected annual dividend yield. |
The Company calculates the expected term using the simplified method, or the arithmetic average of the original contractual term and the average vesting term, for “plain vanilla” stock option awards. The risk-free interest rate is based on the yield available on U.S. Treasuryzero-coupon issues similar in duration to the expected term of the stock-based award. The Company’s common stock isnot publicly traded; therefore, it uses the weighted average of the historic volatilities of the stock price of similar publicly traded peer companies, with extra weighting attached to those companies most similar in terms of size, financial leverage, and business activity. The Company utilizes a dividend yield of zero, as it hasno history or plan of declaring dividends on its common stock.
Leases
The Company records operating leases as right-of-use assets and operating lease liabilities in its consolidated balance sheets for all operating leases with terms exceedingone year. Right-of-use assets represent the right to use an underlying asset for the lease term, including extension options considered reasonably certain to be exercised, and operating lease liabilities represent obligations to make lease payments. Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term. To the extent that lease agreements donot provide an implicit rate, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of lease payments. The expense for operating lease payments is recognized on a straight-line basis over the lease term and is included in operating expenses in the Company’s consolidated statement of operations. The Company has elected tonot separate lease and non-lease components of its operating leases.
Segment Information
Operating segments are defined as components of an enterprise for which separate financial information is evaluated regularly by the chief operating decision maker (“CODM”) who is the Company’s chief executive officer, chief financial officer, and chief operating officer, in deciding how to allocate resources and assess the Company’s financial and operational performance. The CODM evaluates the Company’s financial information and resources and assesses the performance of these resources on a consolidated and aggregated basis. Accordingly, the Company has determined that it operates inone operating and reportable segment.
The Company internally reports the following segment financial information, on a consolidated basis, to its CODM: revenue by product and rentals, cost of revenues by product and rentals, and gross profit. Gross profit is the measure of segment profitability used by the CODM to assess performance and allocate resources and is presented on the consolidated statements of operations and comprehensive loss. The CODM also reviews the disaggregation of revenue by geography that is presented in Note5. There areno segment operating expenses that require disclosure other than the expense categories presented on the consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the consolidated balance sheets as total assets.
Reclassification
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications hadno effect on the reported results of operations.
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| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.) |
Recent Accounting Pronouncements
In* December2023,* the FASB issued ASU2023-09, Income taxes (Topic740), Improvement to income tax disclosures, which enhances the disclosures required for income taxes in the Company’s annual financial statements. This standard is effective for fiscal years beginning after* December15,* 2024, with early adoption permitted. The Company has adopted this pronouncement on* January**1,* 2025, withno material impact on the Company’s financial statements.
In* November2024,* the FASB issued ASU2024-03, Disaggregation of Income Statement Expenses (DISE), which applies to all public business entities. This standard is effective for annual reporting periods beginning after* December15,* 2026, with early adoption permitted. The Company expects to adopt this standard for the period beginning after* December**15,* 2026.
The Company has reviewed all newly issued accounting pronouncements and concluded that they either arenot applicable to the Company’s operations, orno material effect is expected on its consolidated financial statements as a result of future adoption.
| 3. | FAIR VALUE OF FINANCIAL INSTRUMENTS |
The following tables present information about the Company’s financial liabilities that are measured at fair value on a recurring basis and the fair value hierarchy of the valuation as of* September 30, 2025and December 31, 2024*.
| (in thousands) | ||||||||||||
| Quoted | ||||||||||||
| Prices in | ||||||||||||
| Active Markets | Significant | Significant | ||||||||||
| for Identical | Observable | Unobservable | ||||||||||
| Assets | Inputs | Inputs | ||||||||||
| Category Class | Total | (Level 1) | (Level 2) | (Level 3) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Derivative Liability | $ | - | $ | - | $ | - | $ | - | ||||
| Total | $ | - | $ | - | $ | - | $ | - | ||||
| (in thousands) | ||||||
|---|---|---|---|---|---|---|
| Quoted | ||||||
| Prices in | ||||||
| Active Markets · Significant · Significant | ||||||
| for Identical · Observable · Unobservable | ||||||
| Assets · Inputs · Inputs | ||||||
| Category Class · Total · (Level 1) · (Level 2) · (Level 3) | ||||||
| Derivative Liability | $6,759 | $ | - | $ | - | $6,759 |
| Total | $6,759 | $ | - | $ | - | $6,759 |
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| 3. | FAIR VALUE OF FINANCIAL INSTRUMENTS (cont.) |
The derivative liabilities relate to the embedded redemption features in connection with the convertible promissory notes. The fair value of the embedded redemption features at issuance of the convertible promissory notes and each reporting period was estimated based on significant inputsnot observable in the market, which represent Level3 measurements within the fair value hierarchy. The Company used a scenario-based model (“SBM”) and a discounted cash flow method to incorporate estimates and assumptions concerning its prospects and market indications into a model to estimate the value of the derivative liability. An SBM considers a range of various potential scenario outcomes assumed to occur with associated probabilities. Cash flow outcomes are then discounted to present value to estimate fair value. The most significant estimates and assumptions used as inputs in the SBM valuation technique impacting the fair value of the embedded redemption features are the timing and probability of a successful financing or initial public offering (“IPO”), maturity, qualified financing or change of control scenario outcomes. The calculated payments due to the holders of the convertible promissory notes were calculated with and without the embedded redemption feature and discounted to present value. The discounted cash flows were calculated using a discount rate at the issuance dates and at the reporting date, based on an assessment of the Company’s credit position and market yields of companies with similar credit risk at the date of each valuation.
The significant unobservable inputs that are included in the valuation of the derivative liabilities at issuance are as follows:
| Input Range | |
|---|---|
| Significant Unobservable Inputs: | |
| Discount rate | 18.7%-25.0% |
| Expected term (in years) | 0.1-0.06 |
| Probability scenarios: | |
| Successful financing/IPO | 27.6%-98% |
| Maturity | 0%-20% |
| Qualified Financing | 0%-3.4% |
| Change of Control | 0%-3.4% |
On* September2,* 2025 the Company successfully completed its IPO. On* September2,* 2025, $4.135 million of the2023 Convertible Notes plus $0.54 million of accrued interest were converted to a total 5,029,463 common shares, $5.7 million of the2024 Convertible Notes plus $0.34 million of accrued interest were converted to a total 6,496,363 common shares, the $3.523 million of the Nexus loan, plus $0.24 million of accrued interest was converted to 4,054,517 common shares, and $3.523 million of the Another Dimension loan, plus $0.24 million of accrued interest was converted to 4,054,517 common shares. For all convertible loans, the balance of the derivative liability was reclassed to Additional Paid In Capital and the remaining unamortized debt discount was recorded as interest expense. The following table provides a rollforward of the aggregate fair values of the derivative liabilities for thenine months ended* September 30, 2025* (in thousands):
| Embedded | ||
|---|---|---|
| Derivative | ||
| Balance as of December 31, 2024 | $6,759 | |
| Initial fair value of derivative liabilities at issuance | 4,447 | |
| Change in fair value | 7,040 | |
| Extinguishment of derivative liability | (18,246) | |
| Balance as of September 30, 2025 | $ | - |
The Company has certain non-financial assets, primarily intangible assets, and goodwill, which are measured at fair value on a nonrecurring basis and are adjusted to fair value only to the extent that an impairment charge is recognized. The Company estimates the fair value of these assets using primarily unobservable inputs; therefore, these are considered Level3 fair value measurements.
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| 4. | CERTAIN BALANCE SHEET COMPONENTS |
| (a) | Inventory, Net |
Inventory, net of provisions for potentially excess, obsolete, or impaired goods, consists of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Raw materials | $5,924 | $6,319 |
| Work in process | 2,280 | 2,764 |
| Finished goods | 1,402 | 1,443 |
| $9,606 | $10,526 | |
| Allowance for excess and obsolete inventory | (3,054) | (2,411) |
| Inventory, net | $6,552 | $8,115 |
| (b) | Property and Equipment, Net |
Property and equipment, net consists of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Equipment | $643 | $643 |
| Furniture and fixtures | 6 | 6 |
| Leasehold improvements | 101 | 101 |
| Total cost | 750 | 750 |
| Less: accumulated depreciation | (581) | (523) |
| Property and equipment, net | $169 | $227 |
Depreciation expense was $58,000, of which $16,000 was included in cost of goods sold, and $119,000, of which $13,000 was included in cost of goods sold, for thenine months ended* September 30, 2025*, and2024, respectively.
| (c) | Intangible Assets, Net |
Intangible assets consist of the following (in thousands):
| Gross · Net | |||
|---|---|---|---|
| Carrying | Accumulated | Carrying | |
| Amount | Amortization | Value | |
| Developed Technology | $760 | $(254) | $506 |
| Trade Name | 120 | (95) | 25 |
| Total | $880 | $(349) | $531 |
| Gross · Net | |||
|---|---|---|---|
| Carrying | Accumulated | Carrying | |
| Amount | Amortization | Value | |
| Developed Technology | $760 | $(206) | $554 |
| Trade Name | 120 | (78) | 42 |
| Total | $880 | $(284) | $596 |
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| 4. | CERTAIN BALANCE SHEET COMPONENTS (cont.) |
Amortization expense for thenine months ended* September 30, 2025and2024* was $65,000, of which $48,000 was included in cost of goods sold for each period.
As of* September 30, 2025*, developed technology and trade name had remaining lives of 8.0 and 1.0 years, respectively. The estimated future amortization expense for the nextfive years and thereafter is as follows (in thousands):
| September 30, | |
|---|---|
| 2025 (three months remaining) | $22 |
| 2026 | 82 |
| 2027 | 64 |
| 2028 | 63 |
| 2029 | 63 |
| Thereafter | 237 |
| Total | $531 |
| (d) | Other Accrued Liabilities |
Other accrued liabilities consist of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Accrued compensation | $1,077 | $941 |
| Accrued clinical and manufacturing expenses | 685 | 617 |
| Accrued professional and consulting services | 49 | 51 |
| Other liabilities, current portion | 6 | 493 |
| Total other accrued liabilities, current portion | 1,817 | 2,102 |
| Other liabilities, noncurrent portion | - | - |
| Total current and noncurrent other accrued liabilities | $1,817 | $2,102 |
Accrued compensation includes sales commissions, payroll, employee paid time off and employee and executive officer bonuses. Accrued clinical and manufacturing expenses represent royalties payable under aten-year worldwide licensing agreement related to intellectual property covering the design and production of valves used in the SynCardia TAH and service costs on drivers returned, mostly from customers outside the U.S. The sums due to the vendor are secured by the license agreement, which is expired. Accrued professional and consulting services represent payables related to legal, accounting, and valuation services provided in preparation of the Company’s period end reporting. At the end of2023, the Company’s management made the decision to terminate its sales and distribution agreement with State of the Art Medical Products, Inc. In connection with the termination of the agreement, the Company agreed to pay a termination penalty of $505,085, payable at $21,045 per month over a period of 24 months and a refund of $415,000 for returned inventory payable on* May**1,* 2025. Any paymentsnot paid on the due dates are subject to a monthly interest of 1%. On* September 30, 2025*$500,000 of the termination penalty has been paid. As of* September 30, 2025*, and* December 31, 2024*, the termination penalty of*$5,000* and $505,000, respectively, has been included in other accrued liabilities. As of* September 30, 2025* and* December 31, 2024*, $72,000 and $16,000 of interest for the termination penalty has been included in accounts payable. As of* September 30, 2025*, the returned inventory of $415,000 is included in accounts payable.
17
| 5. | REVENUE |
Disaggregation of Revenue
The Company believes that the nature, amount, timing and uncertainty of its revenue and cash flows and how they are affected by economic factors are most appropriately depicted by (i) geographic region, based on the shipping location of the customer, and (ii) type of product or service provided.
Total revenue based on the disaggregation criteria described above is as follows (dollars in thousands):
| Nine Months Ended September 30, | ||||
|---|---|---|---|---|
| 2025 · 2024 | ||||
| % of | % of | |||
| Revenue | revenue | Revenue | revenue | |
| Revenue by geographic area | ||||
| United States | $3,522 | 90% | $2,657 | 75% |
| Europe | 409 | 10% | 763 | 21% |
| Rest of the world | - | 0% | 135 | 4% |
| Total | $3,931 | 100% | $3,555 | 100% |
| Revenue by type | ||||
| Products | $3,859 | 98% | $3,498 | 98% |
| Rentals | 72 | 2% | 57 | 2% |
| Total | $3,931 | 100% | $3,555 | 100% |
Revenue from products includes related services, which represented less than 10% of product revenue for both periods. In thenine months ended* September 30, 2025*, sales included $485,000 or 12% of total revenue to Serbia and $3.5 million or 90% of total revenue to the United States. In thenine months ended* September 30, 2024*, sales included $494,000 or 14% of total revenue to Serbia. Customer concentrations are recorded in Note6.
Contract assets. There wereno contract assets, representing unbilled receivables where revenue has been recognized in advance of customer billings, as of* September 30, 2025* and* December 31, 2024*.
Remaining Performance Obligations. Remaining Performance Obligations (“RPO”) comprise deferred revenue plus unbilled contract revenue. As of* September 30, 2025* and* December 31, 2024*, there wasno RPO.
| 6. | CONCENTRATIONS |
Customers accounting for more than10% of revenue in any of the periods presented are summarized as follows (in thousands, except percentages):
| Nine Months Ended September 30, | ||||
|---|---|---|---|---|
| 2025 · 2024 | ||||
| Customer A | $1,944 | 49% | $1,796 | 51% |
| Customer C | $546 | 14% | $5 | 0% |
| Customer E | $485 | 12% | $494 | 14% |
As of* September 30, 2025*, Customer A accounted for $357,000 or 40%, Customer E accounted for $174,000 or 20%, Customer F accounted for $179,000 or 20%, and Customer D accounted for $182,000 or 20% of the accounts receivable balance.
18
| 6. | CONCENTRATIONS (cont.) |
As of* December 31, 2024*, Customer B accounted for $249,000 or 48% and Customer D accounted for $173,000 or 34% of the accounts receivable balance.
Concentrations of revenues derived from foreign countries are disclosed in Note5.
Long-lived assets by geographic areas as of* September 30, 2025* and* December 31, 2024*, are as follows (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| United States | $157 | $213 |
| Foreign, principally in Europe | 12 | 14 |
| Property and equipment, net | $169 | $227 |
| 7. | COMMITMENTS AND CONTINGENCIES |
| (a) | Leases |
The Company has obtained the right of use for office and manufacturing facilities under an operating lease agreement with an initial term exceedingone year and hasone operating lease agreement for office equipment with an initial term exceedingone year, andtwo with initial terms of less thanone year. At the end of* March2024,* the Company established a new financing lease for office equipment for longer thanone year. Right-of-use assets acquired under this finance lease at the time of acquisition were $177 thousand. The weighted average discount rate was 6.27% and the weighted average remaining term of this lease at* September 30, 2025* was 1.5 years. In* April2024,* the Company established a new financing lease for office equipment for longer thanone year. Right-of-use asset acquired under this finance lease at the time of acquisition was $26 thousand. The weighted average discount rate was 10.4% and the weighted average remaining term of this lease on* September 30, 2025* was 1.75 years.
Right-of-use assets acquired under finance and operating leases as of* September 30, 2025* and* December 31, 2024*, consist of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Finance leases: | ||
| Office equipment | $144 | $177 |
| Finance lease right-of-use assets, net | $144 | $177 |
| Operating Leases: | ||
| Facilities | $440 | $653 |
| Office equipment | 34 | 47 |
| Operating lease right-of-use assets, net | $474 | $700 |
The Company obtained the right of use of real estate located in Tucson, Arizona, in* February2015* under a lease that terminated on* December31,* 2022, which was subsequently renewed from* February1,* 2022, until* January31,* 2027, withno extension option. Thefirst 5.5 months of the renewed term were rent-free, and rent payments escalate annually by 2.5%. As of* September 30, 2025* and* December 31, 2024*, the weighted average discount rate for operating leases with initial terms of more thanone year was 12.0% and the weighted average remaining term of these leases was 1.21 and 1.95 years, respectively. On* October**14,* 2024 the Company established a newtwelve (12) month financing lease for equipment. Right-of-use asset acquired under this finance lease at the time of acquisition was $40,000. The lease contains a $1.00 purchase option at the end of the lease term.
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| 7. | COMMITMENTS AND CONTINGENCIES (cont.) |
The following table summarizes the Company’s undiscounted cash payment obligations for its operating and finance lease liabilities with initial terms of more thantwelve months as of* September 30, 2025* (in thousands):
| Operating · Finance | ||
|---|---|---|
| Leases · Lease | ||
| 2025 (three months remaining) | $116 | $12 |
| 2026 | 412 | 77 |
| 2027 | 35 | 27 |
| 2028 | - | - |
| Undiscounted total | 563 | 116 |
| Less: imputed interest | (55) | (8) |
| Present value of future minimum payments | 508 | 108 |
| Current portion of lease liability | (372) | (64) |
| Lease liability, net of current portion | $136 | $44 |
Certain operating lease agreements for facilities include non-lease costs, such as common area maintenance, which are recorded as variable lease costs. Cash paid for amounts included in the measurement of operating lease liabilities totaled $339,000 and $305,000 for thenine months ended* September 30, 2025* and* September 30, 2024*, respectively. Operating lease expenses for thenine months ended* September 30, 2025* and* September 30, 2024*, are summarized as follows (in thousands):
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2025 | 2024 | |
| Operating lease cost | $307 | $286 |
| Short-term lease cost | 8 | 10 |
| Variable lease cost | 51 | 9 |
| Total operating lease cost | $366 | $305 |
Cash paid under finance leases totaled $59,000 and $38,000 in thenine months ended* September 30, 2025*, and2024, respectively.
| (b) | China Corporation |
On* July**2,* 2023, the Company granted SynCardia Medical (Beijing), Inc. (“SynCardia Beijing”) exclusive distribution rights of its products in mainland China, Hong Kong, Macau, and Taiwan. Contingent on the Company becoming publicly traded on a stock exchange, it would be committed to contribute approximately $2.85 million in exchange for a 60% ownership interest and control of the board of directors of SynCardia Beijing. Should this occur, non-controlling owners would also invest approximately $2.85 million to obtain a 40% ownership interest in SynCardia Beijing and the Company would begin to consolidate its results in its consolidated financial statements.
As of* September 30, 2025,the Company hadnot* consummated the contemplated investment, and SynCardia Beijing continued to operate solely as an independent distributor. The agreement remains in effect; however, the Company is monitoring international and market conditions and intends to proceed when such conditions have stabilized and are supportive of the planned investment. Accordingly,no amounts related to this arrangement have been recognized in the Company’s condensed consolidated financial statements as of and for thethree andnine months ended* September 30, 2025.*
| (c) | Indemnifications |
In the ordinary course of business, the Company enters into agreements that* mayinclude indemnification provisions. Pursuant to such agreements, the Company mayindemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising fromthird*-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions isnot determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company currently has directors’ and officers’ insurance.
20
| 7. | COMMITMENTS AND CONTINGENCIES (cont.) |
| (d) | Litigation |
From time to time the Company* maybe involved in claims arising in connection with its business. Based on information currently available, the Company believes that the amount, or range, of reasonably possible losses in connection with any pending actions against it in excess of established reserves, in the aggregate,not to be material to its consolidated financial condition or cash flows. However, losses may*be material to the Company’s operating results for any particular future period, depending on the level of income or loss for such period.
| 8. | CONVERTIBLE NOTES |
During the period* Maythrough Septemberof2023,* the Company issued unsecured convertible notes (the*“2023* Convertible Notes”) for a total of $4.2 million, $300,000 of which is from a limited partner in Hunniwell Picard I, LLC (“Hunniwell”), which ,immediately subsequent to our IPO closing, owns a majority of the Company’s outstanding common stock, which accrue simple interest at 6% per annum commencing on the issuance date of each2023 Convertible Note. Issuance costs werenot significant and interest accrued totaled $0 and $375,000 as of* September 30, 2025* and* December 31, 2024*, respectively. The maturity date of each2023 Convertible Note istwo years after the issuance date. Each2023 Convertible Note shall be automatically converted into a number of shares of PMI’s common stock equaling the outstanding balance of the note, being the principal plus accrued interest, divided by 3.2714, on the maturity date or, if sooner, on the day before the Company becomes publicly traded on a stock exchange. The Company determined that the2023 Convertible Notes didnot contain any embedded derivatives requiring bifurcation.
In* April,** Mayand July2025,* the Company amended $4.135 million of the $4.160 million2023 Convertible Notes to extend the maturity date until* August25,* 2025, and change the automatic conversion rate to a conversion price equal to 50% (23% post split) of the lowest price per share paid by purchasers of our securities in the event we consummate an IPO (the “Amended Conversion”). On* September 9, 2025*$0.025 million of the2023 Convertible Notes plus interest was paid in cash.
The Company determined that the Amended Conversion features on the2023 Convertible Notes met the definition of embedded derivatives that were required to be bifurcated and accounted for as derivative liabilities. The Company recorded the fair value of the derivative liabilities at issuance of $3,097,542 as a debt discount to the2023 Convertible Notes and is amortized to interest expense over the term of the notes. Amortization expense for thethree andnine months ended* September 30, 2025* amounted to $1,1,459,854 and $3,097,542, respectively. The debt discount was fully amortized as of* September 2, 2025.The Company evaluated the amendment of the $4.135 million2023* Convertible Notes under the guidance in ASC470-50, Debt Modifications and Extinguishments, and determined that the amendment was substantive. The original debt and amended debt have the same principal, interest rate andno consideration was received by the debtor in exchange for the amended note, meaning the net carrying amount of the original debt is equal to the reacquisition amount of the amended debt, thereforeno gain or loss on the extinguishment accounting was recognized. As such, the embedded conversion feature is accounted for at fair value at the amendment date and changes in the fair value of the Amended Conversion option are charged to earnings. On* September, 2, 2025,$4.135 million of the2023* Convertible Notes plus $0.54 million of related interest were converted to a total 5,029,463 common shares, and the balance of the derivative liability was reclassed to Additional Paid In Capital.
Between* April2024* and* May, 2025,the Company delivered a Convertible Note Purchase Agreement (“2024* Convertible Note Agreement”) to prospective investors seeking to raise an aggregate amount of up to $15.0 million (“2024 Convertible Note”). The unsecured2024 Convertible Notes accrue simple interest at 6% per annum commencing on the issuance date of each2024 Convertible Note. The maturity date of each2024 Convertible Note issix months after the issuance date, or if sooner, on the date in which the Company consummates an IPO. Each2024 Convertible Note, together with unpaid accrued interest, shall be automatically converted into the securities issued in the IPO at a conversion price equal to 50% (23% post split) of the lowest price per share paid by the other purchasers of equity securities in the IPO (“conversion price”). Alternatively, in the event the Company consummates an equity, debt, or other financing prior to an IPO, then all principal, together with all unpaid accrued interest under the2024 Convertible Notes, shall automatically convert, in the event of an equity financing, into the securities issued at a conversion price equal to 50% (23% post-split) of the lowest price per share paid by the other purchasers of equity securities prior to such financing, or, in the event of a debt financing prior to an IPO, the terms of these2024 Convertible Notes shall be amended and restated to match the terms of such debt financing at the lender’s option. The Company has raised total principal of approximately $5.7 million as of* September 30, 2025.The Company determined that the conversion features on the2024* Convertible Notes met the definition of embedded derivatives that were required to be bifurcated and accounted for as derivative liabilities. The Company recorded the fair value of the derivative liabilities at issuance of $1,825,280 as a debt discount to the2024 Convertible Notes and is amortized to interest expense over the term of the notes. Amortization expense for thethree andnine months ended* September 30, 2025* amounted to $719,598 and$1,405,891, respectively. In* July2024,* $2.7 million of the $5.7 million2024 convertible notes were modified to reduce the conversion percentage from 80% to 50% (37% to 23% post-split). The Company evaluated the modification of the $2.7 million2024 Convertible Notes under the guidance in ASC470-50, Debt Modifications and Extinguishments, and determined that the modification wasnot substantive. Since the embedded conversion feature is accounted for at fair value both before and after modification, changes in the fair value of the conversion option are charged to earnings. On* September 2, 2025,$5.7 million of the2024* Convertible Notes plus $0.34 million of related interest were converted to a total 6,496,363 common shares, the balance of the derivative liability was reclassed to Additional Paid In Capital and the remaining unamortized debt discount was fully amortized to interest expense.
21
| 8. | CONVERTIBLE NOTES (cont.) |
On* November12,* 2024, Richard Fang, former Chief Executive Officer and current director, donated the $7.0 million aggregated convertible note, dated* July2,* 2024, and the related accrued interest, to thenot for profits organizations, Nexus Science Foundation Inc. (“Nexus”), and Another Dimension Foundation (“Another Dimension”). Under this donation, Nexus and Another Dimension will each receive 50% of the converted value in registered shares. On* September 2, 2025,*$3.5 million of the Nexus note plus $0.24 million of related interest, and $3.5 million of the Another Dimension note plus $0.24 million of related interest were converted to 4,054,517 and 4,054,517 common shares, respectively, the balance of the derivative liability was reclassed to Additional Paid In Capital and the remaining unamortized debt discount was fully amortized to interest expense.
The following table summarizes the balances of the convertible notes*(in thousands)*:
| As of | ||||
|---|---|---|---|---|
| September 30, · December 31, | ||||
| 2025 · 2024 | ||||
| 2023 Convertible Notes | $ | - | $4,160 | |
| 2024 Convertible Notes | - | 10,746 | ||
| Less: unamortized debt discount | - | (78) | ||
| Subtotal | $ | - | $14,828 | |
| Less: Current portion | - | (14,828) | ||
| Convertible notes, net of current portion | $ | - | $ | - |
| Accrued cumulative interest: | $ | - | $725 | |
| 9. | TEMPORARY EQUITY AND STOCKHOLDER’S DEFICIT |
| (a) | Redeemable Convertible Preferred Stock |
In* September**2021,* the Company amended the Articles of Incorporation to allow for the issuance of 30,000,000 shares of Series A-1 Preferred Stock (as defined below). Upon certain change in control events that are outside of the Company’s control, including sale of substantially all of the Company’s assets or the occurrence of a Deemed Liquidation Event (as defined in the Company’s amended and restated Articles of Incorporation), the holders of the shares of Series A-1 Preferred Stock* maycause redemption of the shares of the Series A-1 Preferred Stock. Accordingly, these shares are considered contingently redeemable and are classified as temporary equity on the accompanying consolidated balance sheets. The Series A-1 Preferred Stock may*be converted at the option of the holder at any time and without the payment of additional consideration by the holder into a number of fully paid and non-assessable shares of common stock based on the terms within the Articles of Incorporation.
22
| 9. | TEMPORARY EQUITY AND STOCKHOLDER’S DEFICIT (cont.) |
In* September2021,* 10,000,000 shares of Series A-1 Preferred Stock were sold for cash proceeds of $1.00 per share, and 2,065,000 shares of Series A-1 Preferred Stock were issued as conversion shares to holders of the then outstanding convertible notes at a price of $1.00 per share. In* December2022,* 5,550,000 shares of Series A-1 Preferred Stock were issued for payment in kind of notes payable at a price of $1.00 per share. In* December**2022,* 791,857 shares of Series A-1 Preferred Stock were issued for a total consideration of $2,650,000. No gain or loss is recognized on the settlement of the $5,550,000 notes as the conversion of the notes and the proceeds received of $2,650,000 were considered capital contributions to reach the $20 million capital raise provided for in the acquisition agreement with Sindex SSI Financing, LLC (“Sindex”).
Following are the rights and privileges related to the Series A-1 redeemable convertible preferred stock (the “Series A-1 Preferred Stock”):
| ● | Dividend Provision: The holders of the preferred stock in preference to the holders of common stock are entitled to receive, if and when declared by the board of directors, dividends at the rate of 12% of the original issue price, defined as $1.00, per annum. Such dividends are cumulative and compound annually. No dividends have been declared to date. In addition, the holders of the preferred stock are entitled to receive a dividend equal to any dividend paid on common stock, when and if declared by the board, on the basis of the number of common shares into which the preferred stock may be convertible. Undeclared dividends with respect to the outstanding Series A-1 Preferred Stock as of September 30, 2025 totaled $0 million, due to the Preferred Conversion described below, and as of December 31, 2024, totaled approximately $7.0 million. In the event of liquidation, dissolution or winding up of the Company, the holders of the Series A-1 Preferred Stock will be entitled to the original issue price plus accrued dividends before any funds are available to common stockholders. |
| ● | Conversion Rights: All holders of the Company’s preferred stock have a right to convert the outstanding balances of preferred shares at any time following the date of issuance into a number of fully paid common shares, as specified in the Articles of Incorporation. The conversion rate is the original issue price for the relevant shares divided by the conversion price of the relevant shares, subject to anti-dilution adjustments. In the event of a sale of shares in a public offering resulting in gross proceeds of $25 million to the Company, such conversion into common stock would be mandatory. The 18,406,857 shares of Series A-1 Preferred Stock outstanding on July 7, 2025 were converted, by the holders, into 39,618,919 shares of common stock. As of September 30, 2025, the were no outstanding Preferred Stock holders. |
| ● | Liquidation Preferences: In the event of any liquidation, dissolution, winding-up or sale or merger of the Company, whether voluntarily or involuntarily, each holder of Preferred Stock is entitled to receive, in preference to the holders of common stock, a per-share amount equal to the original issue price, plus all declared but unpaid dividends. As of September 30, 2025, the redemption preference on liquidation would be approximately $0 million, due to the Preferred Conversion described below. |
| ● | Voting Rights: Each holder of outstanding shares of Preferred Stock is entitled to the number of votes equal to the number of whole shares of Common Stock into which the shares of Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Holders of Preferred Stock vote together with the holders of Common Stock on an as-converted-to-Common-Stock-basis and not as a separate class. |
Preferred Conversion: On* July 7, 2025,*Hunniwell exercised the option to convert all of its Series A-1 Preferred Stock to 39,619,919 shares of common stock. At the time of conversion,no dividends were declared or paid.
| (b) | Common Stock |
The Company is authorized to issue 150,000,000 shares of common stock, $0.0001 par value per share. The voting, dividend and liquidation rights of the common stock are subject to and qualified by the rights, powers, and preferences of the holders of the Series A-1 Preferred Stock. The Company shallnot declare or pay a dividend on any share of Preferred Stock without also declaring or paying a dividend on any share of common stock that is equal to the dividend declared and or paid on the share of Preferred Stock divided by the number of shares of common stock into which such share of Preferred Stock is then convertible.
The holders of common stock are entitled toone vote per share at all meetings of stockholders, provided that they* may**not* vote to amend the Certificate of Incorporation relating to the terms of any outstanding series of Preferred Stock if the holders of that series are entitled to vote thereon. The number of authorized shares of common stock* mayonly be changed by the affirmative vote of the holders of a majority of shares outstanding. There areno* sinking fund provisions applicable to the common stock.
23
| 9. | TEMPORARY EQUITY AND STOCKHOLDER’S DEFICIT (cont.) |
The Company had shares of common stock reserved for issuance as follows:
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Conversion of Convertible Notes | - | 1,386,344 |
| Options issued and outstanding | 7,647,597 | 7,210,742 |
| Available for future grants of equity awards | 746,763 | 1,183,618 |
| Total | 8,394,360 | 9,780,704 |
| (c) | US Unicorn Agreement |
On* August 19, 2024,the Company entered into an Acceleration Program Participation Agreement (the “Participation Agreement”), a memorandum of understanding (the “MOU”), a Share Issuance Agreement (the “Share Issuance Agreement”) and a side letter (the “Side Letter,” and, together with the Participation Agreement, the MOU and the Share Issuance Agreement, the “Unicorn Agreements”) with the US Unicorn Foundation, Inc. (“Unicorn”) to provide advisory services in relation to the Company’s planned IPO listing (“Listing”). More specifically, Unicorn will make its best effort to raise, $5 million in capital for the pre-IPO financing round, and connect the Company with underwriters that could support the Listing, as well as other Listing related services in exchange for 2% of Company equity due on signing of the Unicorn agreement, followed by an additional 3% of Company equity if a follow-on financing is completed within12* months of the Listing. The Side Letter also provides that if the Company doesnot complete an IPO within12 months from the date of the agreement or if the Company abandons its pursuit of an initial public offering, Unicorn shall promptly return the Unicorn Shares to the Company. On* August**25,* 2024, the Company issued 1,342,650 shares at a fair value of $0.80 per share to Unicorn in satisfaction of the 2% of Company equity due on signing of the Unicorn agreement. On* July 21, 2025,the Company sent a notice of termination to Unicorn to terminate Unicorn Agreements. On August 22, 2025,*the 1,342,650 shares were returned and were then cancelled by the Company.
| (d) | Common Stock Issuance |
In* March**2025,* the Company entered into subscription agreements with certain investors for the sale of 352,852 shares of the Company’s common stock at a price of $1.42 per share for total consideration of $500,000.
In* April**2025,* the Company entered into subscription agreements with certain investors for the sale of 695,277 shares of the Company’s common stock at a price of $1.42 per share for total consideration of $1.0 million.
On* July**7,* 2025, Hunniwell exercised the option to convert all of its Series A-1 Preferred Stock to 39,618,919 shares of common stock. At the time of conversion, no dividends were declared or paid.
In* July 2025,the Company received $0.75 million fromthree* investors for the purchase of 568,184 shares of common stock at a price of $1.32 per share.
(e)Completion of Initial Public Offering (“IPO”)
On* September 2, 2025,the Company completed its IPO of 4,250,000 shares of common stock at a price of $4.00 per share for gross proceeds to the Company of $17 million. In connection with the IPO, the2023* Convertible Notes,2024 Convertible Notes and Another Dimension and Nexus notes were automatically converted into 19,634,860 shares of common stock. The offering cost of the IPO included approximately $4.16 million in underwriter commissions , legal expenses and other related offering costs resulting to net proceeds to the Company of $12.859 million.
On* September 9, 2025,*the Company completed the closing of the underwriter over allotment for 637,500 shares of common stock at a price of $4.00 per share for gross proceeds to the Company of $2.6 million. The offering costs of this closing were $0.2 million in underwriter commissions and expenses, for net proceeds to the Company of $2.35 million.
| 10. | SHARE BASED COMPENSATION |
On* September**26,* 2021, the Company’s board of directors approved the adoption of the2021 Equity Incentive Plan (the*“2021* Plan”), under which the Company is authorized to issue incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, other stock awards and performance awards that* may*be settled in cash, stock, or other property.
The aggregate number of shares of common stock authorized for issuance under the2021 Plan is 8,394,360 shares, which* maybe increased through an amendment to the2021* Plan adopted by the board of directors. The number of shares authorized is subject to standard adjustments in the event of a stock split, stock dividend or other extraordinary dividend, or other similar change in the Company’s common stock or capital structure. Awards that expire or are cancelled generally become available for issuance again under the2021 Plan. Awards have a maximum term often years from the grant date and vest over four years, but* mayvest over varying periods, as specified by the Company’s board of directors for each grant. In October, 2025,the Company amended the2021* Plan as described in the below footnote**15.* Subsequent Events.*
24
| 10. | SHARE BASED COMPENSATION (cont.) |
A summary of stock option transactions for thenine months ended* September 30, 2025* is as follows:
| Weighted | |||
|---|---|---|---|
| Shares | Number of | Average | |
| Available | Options | Exercise | |
| For Grant | Outstanding | Price | |
| Balance at December 31, 2024 | 1,094,024 | 7,300,336 | $0.49 |
| Granted | (764,980) | 764,980 | $2.11 |
| Forfeited | 128,309 | (128,309) | $0.23 |
| Cancelled | 289,410 | (289,410) | $0.41 |
| Balance at September 30, 2025 | 746,763 | 7,647,597 | $0.66 |
As of* September 30, 2025*, there were 7,647,597 options outstanding, with a weighted average exercise price of $0.66, a weighted average remaining term of 7.36 years, and an aggregate intrinsic value of $60.0 million. Of these,4,930,433 were vested, with a weighted average exercise price of $0.43, a weighted average remaining term of 6.81 years and an aggregate intrinsic value of $39.8 million. The options vest over a period of 4 years.
The aggregate intrinsic value represents the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of* September 30, 2025*, which, based on the active market for the Company’s common stock, was valued at*$8.50* per share, which would have been received by the option holders had all their in-the-money options been exercised and sold as of that date. No options have been exercised since the2021 Plan’s adoption.
On* May 30, 2025,the Company granted 764,980 stock options with a post stock split exercise price of $2.11 and a term of 10 years. The options vest over a period of 4 years. The Company measures the fair value of all stock-based awards on the grant date and records the fair value of these awards to compensation expense over the vesting period. The fair market value of the May 30, 2025*stock-based awards was determined using the Black-Scholes option pricing model which used the following assumptions:
| Stock Price | $1.42 |
|---|---|
| Expected dividend yield | 0% |
| Expected stock price volatility | 189% |
| Risk-free interest rate | 4.69% |
| Expected term (years) | 6.08 |
Total stock-based compensation recognized for options was as follows (in thousands):
| Nine Months Ended | ||
|---|---|---|
| September 30, | September 30, | |
| 2025 | 2024 | |
| Cost of revenue | $42 | $9 |
| Research and development | 15 | 10 |
| Selling, general and administrative | 471 | 641 |
| Total stock-based compensation | $528 | $660 |
As of* September 30, 2025*, the unrecognized stock-based compensation cost related to outstanding stock options that are expected to vest was$1,923,000 which the Company expects to recognize over an estimated weighted average period of 2.76 years.
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| 11. | INCOME TAXES |
The primary differences between the federal statutory income tax rate and the Company’s effective tax rate are due to permanent differences such as meals and entertainment expenses that are non-deductible for tax, state income taxes, the net change in valuation allowance, and other non-taxable items.
The tax effects of temporary differences and carryforwards that gave rise to significant portions of the deferred tax assets and liabilities for thenine months ended* September 30, 2025and2024*, were net operating loss carryforwards, accruals and reserves, credits, fixed assets, and other items.
At* December 31, 2024*, a full valuation allowance was provided for the tax benefits that* may**not* be realized and is still in effect at* September 30, 2025*. Management believes, based on a variety of factors, it is more likely thannot that the deferred income tax assets willnot be fully realized.
| 12. | NET LOSS PER SHARE |
Basic and diluted net loss per share are shown in the consolidated statements of operations and comprehensive loss.
No adjustment has been made to the net loss for charges related to the2023 Convertible Notes,2024 Convertible Notes or Series A-1 Preferred Stock as the effect would be anti-dilutive due to the Company’s net loss. The following outstanding stock options and shares issuable upon conversion of the Convertible Notes and the Series A-1 Preferred Stock werenot considered in the computation of diluted net loss per share attributable to holders of common stock as they had antidilutive effects for thenine months ended* September 30, 2025and2024*:
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2025 | 2024 | |
| Common shares issuable upon exercise of common stock options | 7,647,597 | 7,670,413 |
| Common shares issuable upon conversion of Convertible Notes | - | 1,367,908 |
| Shares issuable upon conversion of Series A-1 Preferred Stock | - | 39,618,919 |
| Total common shares excluded from denominator for diluted earnings per share computation | 7,647,597 | 48,657,240 |
| 13. | RETIREMENT PLANS |
The Company maintains a401(k) Plan for the benefit of eligible employees in the United States. The401(k) Plan includes a cash or deferred arrangement pursuant to Section401(k) of the Internal Revenue Code sponsored by the Company to provide eligible employees an opportunity to defer compensation and have such deferred amounts contributed to the401(k) Plan on a pre-tax basis, subject to certain limitations. The Company, at the discretion of the Board of Directors,* maymake contributions of cash to match deferrals of compensation by participants in the401*(k) Plan. To date, the Company has madeno matching contributions to the401(k) Plan.
| 14. | RELATED PARTY TRANSACTIONS |
Versa Capital Management, LLC (“Versa”) shares common ownership with Sindex, which owned 100% of the outstanding membership interest of SynCardia prior to the acquisition by PMI. To enable Versa to pay transaction costs on behalf of SynCardia in conjunction with PMI’s acquisition, on* September**27,* 2021, PMI advanced $100,000 to Versa under an unsecured promissory note (the “Versa Note”) which accrues interest at 8% per annum, compounding annually, repayable within18 months. The balance receivable under the Versa Note, including accrued interest, was $137,000 as of* September 30, 2025,and $112,000 as of September 30, 2024.This note receivable hasnot* been collected. The Versa Note is included within the caption “Due from related parties” within current assets.
On* January11,* 2024, the Company borrowed $1.0 million from Fang Family Fund, LLC, an entity affiliated withone of its executive directors. This loan was consolidated in a convertible note on* July2,* 2024 (“FFF Convertible Note”) as described below.
On* February6,* 2024, the Company borrowed $450,000 from Fang Family Fund, LLC, an entity affiliated withone of its executive directors, under an interest-free loan which was repaid on* February8,* 2024.
On* February21,* 2024, the Company borrowed $450,000 from Fang Family Fund, LLC, an entity affiliated withone of its executive directors. This loan was consolidated in a convertible note on* July2,* 2024 (“FFF Convertible Note”) as described below.
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| 14. | RELATED PARTY TRANSACTIONS (cont.) |
On* March11,* 2024, the Company borrowed $500,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors, under an interest-free loan which was repaid on* May17,* 2024.
On* March28,* 2024, the Company borrowed $500,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors. This loan was consolidated in a convertible note on* July2,* 2024 (“FFF Convertible Note”) as described below.
On* April10,* 2024, the Company borrowed $500,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors. This loan was consolidated in a convertible note on* July2,* 2024 (“FFF Convertible Note”) as described below.
On* April17,* 2024, the Company borrowed $200,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors, under an interest-free loan which was repaid on* May17,* 2024.
On* June5,* 2024, the Company borrowed $500,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors. This loan was consolidated in a convertible note on* July2,* 2024 (“FFF Convertible Note”) as described below.
On* June25,* 2024, the Company borrowed $350,000 from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors, under an interest-free loan, repayable aftersix months or, if sooner, on a date withintwo months of the loan execution date in on which $1,000,000 in external funding is received. On* November18,* 2024, $172,450 of this loan has been repaid. On* May 6, 2025,$90,000 of this loan has been repaid. On September 3, 2025*the $87,500 remaining balance on this loan was repaid.
Effective* July2,* 2024, all loans outstanding as of* June20,* 2024, from Richard Fang, Fang Family Fund, LLC and Fang Family Fund II, LLC, were consolidated intoone loan with a total principal amount of approximately $7.0 million. This loan accrues simple interest at the rate of 6% per annum, and is repayable aftersix months, unless amended. However, in the event of an initial public offering, while the loan remains outstanding, all principal, together with all unpaid accrued interest, would be automatically converted into common stock of the Company at a 77% discount to the lowest price per share paid by the other purchasers of the equity securities in the initial public offering. The Company evaluated the modification of the notes under ASC470-50, Debt Modifications and Extinguishments, and determined that the notes were extinguished due to the addition of a substantive conversion option. There wasno gain or loss from the debt extinguishment. The Company determined that the conversion feature on the convertible note met the definition of an embedded derivative that was required to be bifurcated recorded the fair value of the derivative liability at issuance of approximately $2.0 million as a debt discount to this convertible note and is amortized to interest expense over the term of the notes. Amortization expense for thenine months ended* September 30, 2025* amounted to $22,000. On* November12,* 2024, Richard Fang, former Chief Executive Officer and current director, has donated the $7.0 million aggregated convertible note, dated* July2,* 2024, and the related accrued interest, to the unrelatednot-for-profit organizations, Nexus Science Foundation Inc. (“Nexus”), and Another Dimension Foundation (“Another Dimension”). Under this donation, Nexus and Another Dimension will each receive 50% of the converted value in registered shares. On* September 2, 2025,the Nexus note and the Another Dimension note were converted, see also**8. Convertible Notes.*
On* July**9,* 2024, we borrowed $580,000 from Fang Family Fund II, LLC, an entity affiliated withone of our executive directors, under a loan which bears interest at the LIBOR rate, compounding monthly, repayable aftersix months or, if sooner, on the date in which $5 million in external funding is received. We have amended this loan to reflect the change to SOFR from LIBOR. This loan plus accrued interest of $31,918 was repaid on* September 4, 2025.*
On* August**7,* 2024, we borrowed $110,000 from Fang Family Fund II, LLC, an entity affiliated withone of our executive directors, under an interest-free loan, repayable aftersix months or, if sooner, on the date on which we go public through a successful IPO or receives $5 million in external funding. This loan was repaid on* September 4, 2025.*
On* August**21,* 2024, we borrowed $350,000 from Fang Family Fund II, LLC, an entity affiliated withone of our executive directors, under an interest-free loan, repayable aftersix months or, if sooner, on the date on which we go public through a successful IPO or receives $5 million in external funding. This loan was repaid on* September 4, 2025.*
On* September**17,* 2024, we borrowed $450,000 from Fang Family Fund II, LLC, an entity affiliated withone of our executive directors, under an interest-free loan, this is a short-term loan and shall become due in full and repaid upon our receipt of the same amount of funds or greater within atwo-month (60 days) period after receiving the subject loan from an external investor (not a related party). If we are unable to repay the loan within atwo-month period after receiving this short-term loan, the Fang Family Fund II, LLC will be entitled to all proceeds from sales until the loan is repaid. This loan was repaid on* September 4, 2025.*
As of* September 30, 2025,the Company determined that it overpaid interest on the above Fang Family loans of $134,712 and recognized this amount as a receivable reported in “Due from related parties” in the consolidated balance sheet as of September 30, 2025.*
Senior Secured Notes:
On various dates in* Januaryand June**2025,* the Company borrowed $1.75 million from Fang Family Fund II, LLC, an entity affiliated withone of its executive directors, under a loan agreement which bears 6% interest per annum. The principal and accrued interest of this Note will be due and payable by the Company in cash at any time before or aftertwelve (12) months from the date of the transfer of funds (the “Maturity Date”) at the Company’s written election or upon written demand by the Holder. Notwithstanding the foregoing sentence, the Company* may,with the written consent of Holder, elect to extend the Maturity Date. Under these notes, the Company unconditionally grants, assigns, and pledges to the Holder a continuing security interest in all of the Company’s right, title, and interest in all currently existing and hereafter acquired or arising Collateral to secure prompt repayment of any and all sums due under this note. On September 4, 2025*the $1.75 million loan plus $0.05 million in interest has been paid.
On* July1,* 2025, the Company amended a $250,000 related party working capital loan, issued on* August20,* 2024, and issued a $93,633 loan to Hunniwell for travel expense reimbursements and a $187,190 loan to Daniel Teo, for severance from prior employment, under the same terms as the Senior Secured Notes. Under the Senior Secured Notes, the Company unconditionally grants, assigns, and pledges to the Holder a continuing security interest in all of the Company’s right, title, and interest in all currently existing and hereafter acquired or arising Collateral to secure prompt repayment of any, and all sums due under the Senior Secured Notes. On* July1,* 2025, the Company extended the maturity date of the Senior Secured Notes to* October15,* 2025. On* September 9, 2025,*the $250,000 related party working capital loan plus $15,781 interest, the $93,633 Hunniwell travel expense reimbursement loan plus $5,237 interest ,and the $187,190 severance loan plus $2,042 interest have been paid.
On* July8,* 2025 the Company borrowed $425,000 from Fang Family Fund I, LLC, an entity affiliated withone of its executive directors, under a loan agreement which bears 6% interest per annum. The principal and accrued interest of this Note will be due and payable by the Company in cash on* October15,* 2025 (the “Maturity Date”) at the Company’s written election or upon written demand by the Holder. Notwithstanding the foregoing sentence, the Company* may,with the written consent of Holder, elect to extend the Maturity Date. Under these notes, the Company unconditionally grants, assigns, and pledges to the Holder a continuing security interest in all of the Company’s right, title, and interest in all currently existing and hereafter acquired or arising Collateral to secure prompt repayment of any and all sums due under this note. On September 4, 2025*the $425,000 loan plus $4,533 interest has been paid.
On* August18,* 2025 the Company borrowed $450,000 from Fang Family Fund I, LLC, an entity affiliated withone of its executive directors, under a loan agreement which bears 6% interest per annum. The principal and accrued interest of this Note will be due and payable by the Company in cash on* October15,* 2025 (the “Maturity Date”) at the Company’s written election or upon written demand by the Holder. Notwithstanding the foregoing sentence, the Company* may,with the written consent of Holder, elect to extend the Maturity Date. Under these notes, the Company unconditionally grants, assigns, and pledges to the Holder a continuing security interest in all of the Company’s right, title, and interest in all currently existing and hereafter acquired or arising Collateral to secure prompt repayment of any and all sums due under this note. On September 4, 2025*the $450,000 loan plus $1,200 interest has been paid.
The term Collateral in the above loans refers to all assets of the Company, including without limitation all of the Company’s right, title, and interest in assets, whether now owned or hereafter acquired or arising and wherever located.
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| 15. | SUBSEQUENT EVENTS |
In connection with the issuance of the consolidated financial statements for thenine months ended* September 30, 2025*, the Company has evaluated subsequent events through the date the consolidated financial statements were issued.
Amended Incentive Plan:
On* October 10, 2025,the Company’s stockholders approved an amendment to the Company’s2021* Equity Incentive Plan (the “Amended Incentive Plan”) to (i) increase the aggregate number of shares of Common Stock available under the2021 Equity Incentive Plan to a total of 18,000,000 shares, (ii) include warrant as a type of awards issuable under the Amended Incentive Plan, and (iii) to ratify the2021 Equity Incentive Plan.
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.