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EBR Systems, Inc.

For the period ended Jun 30, 2025. Filed Aug 12, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 12, 2025

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

Notes to the Unaudited Condensed Consolidated Financial Statements

Note 1 - Business and organization

Business overview

EBR Systems, Inc. and subsidiaries (collectively, “EBR”, “we”, “our” or the “Company”) is a United States based medical device company that developed the WiSE CRT System (“WiSE”), an implantable cardiac device able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of leads. This implantable device delivers left-ventricle endocardial pacing for cardiac resynchronization therapy (“CRT”), without the use of wires or leads going into the heart. On April 11, 2025, the Company received notification that the U.S. Food and Drug Administration (“FDA”) has completed its review of the premarket approval application (“PMA”) and approved WiSE for commercial distribution in the United States.

The Company completed its initial public offering of CDIs (“CHESS Depositary Interests”) and began trading on the Australian Securities Exchange (“ASX”) on November 24, 2021, under the symbol “EBR”.

The Company operates wholly owned foreign subsidiary entities in Australia, EBR Systems (AUST) Pty Ltd (“EBR-AU”), and the United Kingdom, EBR Systems (UK) Limited (“EBR-UK”), which establish clinical trials in Australia and the United Kingdom, respectively, and work on intellectual property development. EBR-AU was incorporated on February 23, 2017, and EBR-UK was incorporated on July 31, 2015.

Note 2 - Summary of significant accounting policies

Basis of presentation

These unaudited condensed consolidated financial statements as of June 30, 2025, and for the three and six months ended June 30, 2025 and 2024, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Certain information and note disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and the notes thereto for the year ended December 31, 2024.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the included disclosures are adequate, and the accompanying unaudited condensed consolidated financial statements contain all adjustments which are necessary for a fair presentation of our unaudited condensed consolidated financial position as of June 30, 2025, unaudited condensed consolidated results of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024, and unaudited condensed consolidated cash flows for the six months ended June 30, 2025 and 2024. The unaudited condensed consolidated results of operations for the three and six months ended June 30, 2025, are not necessarily indicative of the consolidated results of operations that may be expected for the year ending December 31, 2025.

Liquidity

The accompanying unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. For the six months ended June 30, 2025 and 2024, the Company incurred a net loss of $22,521,711 and $20,644,691, respectively. During the six months ended June 30, 2025 and 2024, the Company had negative cash flows from operations of $25,040,233 and $20,386,338, respectively. The Company has incurred operating losses and negative cash flows from operations since inception and anticipates such conditions to continue in the foreseeable future. As of June 30, 2025, the Company had working capital of $80,657,255 and accumulated deficit of $375,979,392. The Company continues to face risks similar to those of other companies of similar size in its industry, including, but not limited the need for successful commercialization of products, the need for additional capital, or financing, to fund operating losses, protection of proprietary technology, and dependence on key individuals. The Company has funded its operations through the issuance of common stock and debt instruments, as further discussed in Note 7, “Notes payable” and Note 9, “Common stock” below.

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates, judgments, and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant estimates and assumptions made by management include the fair value of stock-based awards issued, capitalized pre-launch inventory, and the valuation allowance on deferred taxes.

Fair Value Measurements

The Company measures certain assets and liabilities at fair value, which is defined as the price that would be received from the sale of an asset or paid to transfer a liability on the measurement date in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability. The fair value measurement guidance establishes a fair value hierarchy which requires the Company to maximize the use of observable inputs when measuring fair value. The following levels of inputs may be used to measure fair value:

·Level 1: Valuation techniques in which all significant inputs are unadjusted quoted prices from active markets for assets or liabilities that are identical to the assets or liabilities being measured.
·Level 2: Valuation techniques in which significant inputs include quoted prices from active markets for assets or liabilities that are similar to the assets or liabilities being measured and/or quoted prices for assets or liabilities that are identical or similar to the assets or liabilities being measured from markets that are not active. Also, model-derived valuations in which all significant inputs are observable in active markets are Level 2 valuation techniques.
·Level 3: Valuation techniques in which one or more significant inputs are unobservable. Such inputs reflect our estimate of assumptions that market participants would use to price an asset or liability.

Foreign currency translation

The functional currencies of our foreign subsidiaries are their local currencies. Accordingly, the Company translates the foreign currency financial statements into US Dollars using the reporting period-end or average exchange rates. Assets and liabilities of these subsidiaries were translated at exchange rates as of the balance sheet dates. Expenses are translated at average rates in effect for the periods presented. The cumulative translation adjustment is included in the accumulated other comprehensive income within stockholders’ equity. Gains and losses arising from the settlement and remeasurement of monetary assets and liabilities denominated in currencies other than the functional currency are included in “loss on foreign currency” in the period in which they occur.

Employee benefits

Employees that satisfy certain eligibility requirements, including requirements related to age and length of service, are eligible to participate in the EBR Systems, Inc. 401(k) Plan (“Plan”). The Plan is intended to qualify as a tax-qualified 401(k) plan so that contributions to the Plan, and income earned on such contributions, are not taxable to participants until withdrawn or distributed from the Plan. Under the Plan, each employee is fully vested in his or her deferred salary contributions. Employee contributions are held and invested by the plan’s trustee as directed by participants. Effective January 1, 2025, the Company began a matching contribution under the Plan. The Company matches 100% of employee contributions to the Plan up to 3% of eligible compensation, with a maximum annual match of $5,000 per employee. Matching contributions vest 25% after one year of service and are fully vested after two years of service. For the three months ended June 30, 2025 and 2024, the Company match expense was $104,040 and $0, respectively. For the six months ended June 30, 2025 and 2024, the Company match expense was $242,370 and $0, respectively.

Cash and cash equivalents

Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash. Cash equivalents are reported at fair value.

Restricted cash

The restricted cash, noncurrent balance of $2,603,568 as of June 30, 2025, relates to cash deposits restricted under letters of credit issued on behalf of the Company in support of indebtedness to creditors incurred in the ordinary course of business. There was no restricted cash as of December 31, 2024.

Marketable securities

Marketable securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes, and corporate debt securities. Marketable securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive income.

On a quarterly basis, the Company reviews its available-for-sale debt securities for credit-related impairment. An investment security is deemed impaired if the fair value of the investment is less than its amortized cost. For available-for-sale debt securities in an unrealized loss position, the Company evaluates at the individual security level whether the decline in fair value has resulted from credit losses or other factors. In making this assessment the Company considers the issuer of the securities and their creditworthiness, any changes to the rating of the security and any adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss exists, an allowance for credit losses is recorded with an offsetting entry to earnings. Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive income.

The Company typically invests in highly-rated securities and generally limits the amount of credit exposure to any one issuer. Additionally, the Company does not intend to sell the impaired securities, and it is not more likely than not that the Company will be required to sell the investments before recovery of the amortized cost bases. Unrealized losses during the three and six months ended June 30, 2025 and 2024 were primarily the result of market conditions, such as increasing interest rate movements, unusual market volatility, or industry-related events. Since the fluctuation in fair value is due to changes in market conditions and not credit quality, and because the Company does not intend to sell the investments and it is more likely than not that the Company will not be required to sell the investments before recovery of their amortized cost bases, the Company concluded that an allowance for credit losses was not required as of June 30, 2025.

Interest and dividends on available-for-sale securities are included in other income and expense. See Note 3, “Cash, cash equivalents, restricted cash, and marketable securities” for additional disclosure on marketable securities.

Concentration of credit risk

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company’s cash and cash equivalents are primarily held at U.S. financial institutions that management believes are of high credit quality. Such deposits exceed federally insured limits.

Accounts and other receivables and allowance for credit losses

Trade receivables represent amounts due from customers for the sale of our product. Non-trade receivables are recorded from amounts due to the Company from contract manufacturers. Unbilled reimbursements represent reimbursement of clinical trial expenses for which reimbursements have not been billed. Reimbursement for leasehold improvements represent allowable costs and fees that will be reimbursed by the landlord in according to the lease agreement. See Note 5, “Condensed consolidated balance sheet components” for additional information on accounts and other receivables.

Trade accounts receivable are recorded at the invoiced amount, net of allowances for credit losses for any potential uncollectible amounts. The allowance for credit losses is based on our assessment of the collectability of accounts. Management regularly reviews the adequacy of the allowance for credit losses on a collective basis by considering the age of each outstanding invoice, each customer’s expected ability to pay and collection history, current market conditions, and reasonable and supportable forecasts of future economic conditions to determine whether the allowance is appropriate. Accounts and other receivables are written-off and charged against an allowance for credit losses when the Company has exhausted collection efforts without success. During the three and six months ended June 30, 2025 and 2024, the Company recorded no provision for credit losses. As of June 30, 2025 and December 31, 2024, the outstanding trade accounts receivable balance was $259,199.

Inventory

Inventory is comprised of raw materials, work-in-progress and finished goods. Inventory is stated at the lower of cost (determined using the first-in, first-out method) or net realizable value. Net realizable value is determined as the estimated selling price in the ordinary course of business.

Pre-launch inventory costs associated with products that have not yet received regulatory approval are capitalized if there is probable future commercial use and future economic benefit. If future commercial use and future economic benefit are not considered probable, then costs associated with pre-launch inventory that has not yet received regulatory approval are expensed as research and development expense during the period the costs are incurred. The determination to capitalize is based on the particular facts and circumstances relating to the product. Capitalization of such pre-launch inventory begins when the Company determines that (i) positive clinical trial results have been obtained in order to support regulatory approval is probable; (ii) uncertainties regarding regulatory approval have been significantly reduced; and (iii) it is probable that these capitalized costs will provide future economic benefit, in excess of capitalized costs. Pre-launch inventory was recorded at the lower of cost (determined using the first-in, first-out method) and net realizable value.

On April 11, 2025, the Company received notification from the FDA that WiSE had been approved for commercial distribution in the United States. At that time, the Company began presenting pre-launch inventory as inventory in the unaudited condensed consolidated financial statements and accompanying notes.

Property and equipment

Property and equipment is carried at acquisition cost less accumulated depreciation. The cost of normal, recurring, or periodic repairs and maintenance activities related to property and equipment are expensed as incurred.

Depreciation is computed using the straight-line method based on the estimated useful lives of the related assets. The estimated useful lives by asset classification are generally as follows:

Schedule of estimated useful lives
Equipment3 - 5 years
Computer software3 years
Leasehold improvementsLesser of 15 years or the remainder of the lease

Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for potential impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that carrying value exceeds fair value. Fair value is determined using various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, depending on the nature of the asset. For the three and six months ended June 30, 2025 and 2024, the Company did not recognize any impairment charges associated with long-lived assets.

***Leases ***

At the inception of a contract, the Company determines whether the contract is or contains a lease based on all relevant facts and circumstances. Leases with a term greater than 12 months are recognized on the balance sheet date as right of use (“ROU”) assets and current and noncurrent lease liabilities, as applicable. The Company has elected not to recognize on the balance sheet leases with terms of 12 months or less. The Company includes lease option extensions in the assessment of the lease arrangement when it is reasonably certain the option will be exercised.

Lease liabilities and the corresponding right of use assets are recorded based on the present value of lease payments to be made over the lease term. The discount rate used to calculate the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right of use asset may be required for items such as initial direct costs or incentives received. Lease payments on operating leases are recognized on a straight-line basis over the expected term of the lease. Lease payments on financing leases are recognized using the effective interest method. See Note 6, “Leases” for additional disclosure on leases.

For all asset classes of its leases, the Company has elected to account for the lease and non-lease components together for existing classes of underlying assets.

Revenue recognition

In accordance with Accounting Standards Codification 606Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when control is transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for the goods or services. To recognize revenue, the Company applied the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied.

The Company recognizes all of its revenue from contracts with customers at a point in time. As the majority of revenue consists of sales of WiSE and battery replacements, where the Company’s sales representative provides assistance at the point of implantation at hospitals or medical facilities, the Company recognizes revenue upon completion of the procedure. The Company also generates a small portion of its revenue from the sale of surgical tool kits that are ordered in advance of a procedure. As the performance obligation is the delivery of the product, the Company recognizes revenue for the surgical tool kits upon shipment to the customers. For all performance obligations, the standalone selling price is directly observable as these goods are sold separately by the Company. Sales prices are specified in the executed customer contract and purchase order prior to the transfer of control to the customer. The Company’s standard payment terms are generally net 30 days.

The following table summarizes revenue from contracts with customers disaggregated by product for the three and six months ended June 30, 2025 and 2024:

Schedule of disaggregated revenue
Three Months Ended · Six Months Ended
June 30, · June 30,
2025 · 2024 · 2025 · 2024
Revenue:
WiSE CRT System$146,070$-$146,070$-
Surgical tool kits3,424-3,424-
Battery replacements20,210-20,210-
Total revenue$169,704$-$169,704$-

Cost of goods sold

The Company purchases components and materials from third-party suppliers and manufacturers. Cost of goods sold consists primarily of costs related to materials, manufacturing overhead costs, reserves for excess, and obsolete and non-sellable inventories. Manufacturing overhead costs includes the cost of material procurement and operations and quality supervision and management personnel, including employee compensation, stock-based compensation, supplies, and travel. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs, such as shipping and handling costs.

Warranty

The Company has a warranty program that offers a warranty on the battery, electrode and transmitter (“Warranty Parts”) of the WiSE for a period of three years commencing on the date of implant. In the event the Warranty Parts function in a manner inconsistent with their intended operation and performance due to the quality of materials or workmanship, and should such an event occur with the three-year period commencing on the implantation date, the Company will provide the customer a replacement at no additional cost. The warranty is not priced or sold separately. It is intended to safeguard the customer against defects, and it does not provide incremental service to the customer. As such, it is considered an assurance type warranty and is not accounted as a service type warranty, which could represent a separate performance obligation. The warranty is accounted for as an accrued warranty reserve. The current portion is included within “Accrued expenses and other liabilities”, and the long-term portion is included within “Other liabilities” in our unaudited condensed consolidated balance sheets. See Note 5, “Condensed consolidated balance sheet components” for additional disclosure on accrued warranty reserves.

Research and development

Research and development costs are expensed when incurred. Research and development costs include operating expenses for the Company’s engineering and product management functions supporting research, new development, and related product enhancement. Additionally, costs incurred in connection with preclinical development, clinical testing, as well as costs associated with the regulatory and FDA approval process are also included as a component of research and development expense.

***Selling, general and administrative ***

Selling, general and administrative includes operating expenses incurred in our executive, finance, legal, sales, marketing, and other administrative functions, as well as losses on the disposal of property and equipment.

Stock-based compensation

The Company recognizes stock-based compensation expense related to employees over the requisite service period based on the grant-date fair value of the awards. The fair value of options granted is estimated using the Black-Scholes option valuation model. The Company recognizes the grant-date fair value of an award as compensation expense on a straight-line basis over the requisite service period, which typically corresponds to the vesting period for the award. The Company elects to account for forfeitures as they occur and, upon forfeiture of an award prior to vesting, the Company reverses any previously recognized compensation expense related to that award. See Note 11, “Stock-based compensation” for additional details.

Other income

The Company periodically receives reimbursements of clinical trial expenses, which are recorded as other income in the accompanying unaudited condensed consolidated statements of operations. During the three months ended June 30, 2025 and 2024, the Company recordedno other income. During the six months ended June 30, 2025 and 2024, the Company recorded reimbursements of $0 and $8,843, respectively.

Income taxes

The asset and liability approach is used for the financial reporting for income taxes. Deferred income balances reflect the effects of temporary differences between the financial reporting and income tax bases of the Company’s assets and liabilities and are measured using enacted tax rates expected to apply when taxes are actually paid or recovered. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses, or NOLs, and research and development credit carryforwards and are measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse.

Income tax expense during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items that are recorded in the interim period. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgement including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in various jurisdictions, permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, and additional information becomes known, or as the tax environment changes.

***Earnings per share ***

Basic income or loss per share is determined by dividing net income or loss by the weighted-average common shares outstanding during the period. Diluted income or loss per share is determined by dividing net income by diluted weighted-average shares outstanding during the period. Diluted weighted-average shares reflect the dilutive effect, if any, of potential common shares. To the extent their effect is dilutive, employee equity awards and other commitments to be settled in common stock are included in the calculation of diluted income or loss per share based on the treasury stock method. Potential common shares are excluded from the calculation of dilutive weighted-average shares outstanding if their effect would be anti-dilutive at the balance sheet date based on a treasury stock method or due to a net loss.

Recently issued accounting pronouncements

In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures”. The ASU focuses on income tax disclosures around effective tax rates and cash income taxes paid. ASU 2023-09 is effective for public filers for fiscal years beginning after December 15, 2024. The adoption of ASU 2023-09 will be reflected in the Company’s annual financial statements for the year ending December 31, 2025 and is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03,Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. In January 2025, the FASB issued an update 2025-01 “*Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date”,*which revises the effective date of ASU 2024-03 to clarify that all public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact of this standard on its disclosures.

Note 3 – Cash, cash equivalents, and marketable securities

Cash, cash equivalents, and marketable securities consisted of the following at June 30, 2025 and December 31, 2024:

Schedule of cash and cash equivalents
June 30, 2025December 31, 2024
Cash and cash equivalents:
Cash$993,266$3,210,556
Money market funds44,000,1583,706,990
Total cash and cash equivalents$44,993,424$6,917,546
Marketable securities, short-term:
Asset backed securities$2,004,057$2,002,957
Commercial paper7,118,2901,156,709
Corporate bonds12,313,21323,951,700
US Treasury securities15,269,30426,635,045
Total marketable securities, short-term$36,704,864$53,746,411
Marketable securities, long-term:
Asset backed securities$2,308,013$2,305,317
Corporate bonds592,0582,386,774
US Treasury securities-611,859
Total marketable securities, long-term$2,900,071$5,303,950
Total cash, cash equivalents, and marketable securities$84,598,359$65,967,907

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within our unaudited condensed consolidated balance sheets as of June 30, 2025 and June 30, 2024, to the total of such amounts as presented in the unaudited condensed consolidated statements of cash flows:

Schedule reconciliation of cash, cash equivalents, and restricted cash
June 30, 2025June 30, 2024
Cash and cash equivalents$44,993,424$8,364,623
Restricted cash, noncurrent2,603,568-
Total cash, cash equivalents, and restricted cash$47,596,992$8,364,623

During the six months ended June 30, 2025, marketable securities were sold or matured for proceeds of $29,120,614 with a realized gain of $8,265. During the six months ended June 30, 2024, marketable securities were sold or matured for proceeds of $34,125,676 withno gain or loss realized. See Note 4, “Fair value measurements” for additional information regarding the fair value of cash equivalents and marketable securities.

The following tables summarizes the unrealized gains and losses related to the Company’s available-for-sale marketable securities, by major security type, as of June 30, 2025 and December 31, 2024:

Schedule of unrealized gains and losses
Amortized Cost · Unrealized Gains · Unrealized (losses) · Fair Value
Marketable securities:
Asset backed securities$4,311,329$741$-$4,312,070
Commercial paper7,120,934164(2,808)7,118,290
Corporate bonds12,906,2993,658(4,686)12,905,271
US Treasury securities15,277,487268(8,451)15,269,304
Total marketable securities$39,616,049$4,831$(15,945)$39,604,935
Amortized Cost · Unrealized Gains · Unrealized (losses) · Fair Value
Marketable securities:
Asset backed securities$4,304,662$3,612$-$4,308,274
Commercial paper1,161,157-(4,448)1,156,709
Corporate bonds26,341,01919,868(22,413)26,338,474
US Treasury securities27,235,91626,291(15,303)27,246,904
Total marketable securities$59,042,754$49,771$(42,164)$59,050,361

The following table shows the unrealized losses and fair values for those marketable securities that were in an unrealized loss position as of June 30, 2025 and December 31, 2024, aggregated by major security type and the length of time the marketable securities have been in a continuous loss position:

Schedule of marketable securities
In Loss Position for Less Than 12 Months · In Loss Position for 12 Months or Greater · Total
Fair Value · Unrealized Losses · Fair Value · Unrealized Losses · Fair Value · Unrealized Losses
Commercial paper$5,371,323$(2,808)$-$-$5,371,323$(2,808)
Corporate bonds8,239,843(4,686)--8,239,843(4,686)
US Treasury Securities14,255,994(8,451)--14,255,994(8,451)
Total$27,867,160$(15,945)$-$-$27,867,160$(15,945)
In Loss Position for Less Than 12 Months · In Loss Position for 12 Months or Greater · Total
Fair Value · Unrealized Losses · Fair Value · Unrealized Losses · Fair Value · Unrealized Losses
Commercial paper$1,156,709$(4,448)$-$-$1,156,709$(4,448)
Corporate bonds13,839,116(22,413)--13,839,116(22,413)
US Treasury Securities14,094,715(15,303)--14,094,715(15,303)
Total$29,090,540$(42,164)$-$-$29,090,540$(42,164)

The contractual maturities of the Company’s marketable securities as of June 30, 2025, were as follows:

Schedule of contractual maturities
Fair Value
One year or less$36,704,864
One year to two years592,058
Two years to three years2,308,013
Total minimum payments$39,604,935

Note 4 – Fair value measurement

Management’s assessment of the significance of a particular input to the fair value measurement requires judgement and may affect the valuation of financial assets and liabilities and their placement within the fair value hierarchy, as discussed in Note 2, “Summary of significant accounting policies”. At June 30, 2025 and December 31, 2024, the fair value measurement of the Company’s financial assets measured on a recurring basis were as follows:

Schedule of fair value, liabilities measured on recurring basis
Level 1 · Level 2 · Level 3 · Total
Cash equivalents:
Money market funds$44,000,158$-$-$44,000,158
Marketable securities:
Asset backed securities-4,312,070-4,312,070
Commercial paper-7,118,290-7,118,290
Corporate bonds-12,905,271-12,905,271
US Treasury securities-15,269,304-15,269,304
Total$44,000,158$39,604,935$-$83,605,093
Level 1 · Level 2 · Level 3 · Total
Cash equivalents:
Money market funds$3,706,990$-$-$3,706,990
Marketable securities:
Asset backed securities-4,308,274-4,308,274
Commercial paper-1,156,709-1,156,709
Corporate bonds-26,338,474-26,338,474
US Treasury securities-27,246,904-27,246,904
Total$3,706,990$59,050,361$-$62,757,351

In the Company’s unaudited condensed consolidated balance sheets, the carrying values of accounts and other receivables, other assets, accounts payable and accrued expenses approximated their fair values due to the nature and relatively short maturities. The fair value of debt approximates its carrying value as it is variable rate debt or has relatively short maturities.

Note 5 – Condensed consolidated balance sheet components

Accounts and other receivables, net

Accounts and other receivables includes amounts due from sales of Company’s product to customers, sales of materials to contract manufacturers, reimbursements of clinical trial expenses incurred, and reimbursements for leasehold improvements. Accounts and other receivables, net were as follows as of June 30, 2025 and December 31, 2024:

Schedule of non trade receivables
June 30, · December 31,
2025 · 2024
Trade receivables$259,199$-
Non-trade receivables421,428433,051
Unbilled reimbursements-8,388
Reimbursement for leasehold improvements1,417,255-
Accounts and other receivables2,097,882441,439
Less: provision for credit losses--
Accounts and other receivables, net$2,097,882$441,439

During the three and six months ended June 30, 2025 and 2024, the Company recordedno provision for credit losses.

Inventory

Inventory consisted of the following as of June 30, 2025, and pre-launch inventory consisted of the following at December 31, 2024:

Schedule of inventory consisted
June 30,December 31,
20252024
Raw materials$1,152,705$2,842,540
Work in process4,585,803-
Finished goods1,707,179-
Inventory$7,445,687$2,842,540
Inventory – current$5,133,867$1,391,008
Inventory – noncurrent$2,311,820$1,451,532

Property and equipment, net

Property and equipment consisted of the following as of June 30, 2025 and December 31, 2024:

Schedule of property and equipment, net
June 30,December 31,
20252024
Equipment$3,642,868$3,433,881
Computer software913,120574,780
Leasehold improvements547,259513,727
Construction in progress1,746,607-
Total property and equipment6,849,8544,522,388
Less: accumulated depreciation and amortization(3,841,107)(3,727,429)
Total property and equipment, net$3,008,747$794,959

As of June 30, 2025, construction in progress pertains to tenant improvements for the Company’s new corporate headquarters, laboratory, and manufacturing facility in Santa Clara, California. Depreciation and amortization expense for the three months ended June 30, 2025 and 2024 was $118,466 and $182,441, respectively. Depreciation and amortization expense for the six months ended June 30, 2025 and 2024 was $197,261 and $395,532, respectively.

In June 2025, the Company retired certain programmer equipment and recorded loss on disposal of fixed assets of $35,153 for the three and six months ended June 30, 2025. The loss on disposal of fixed assets is included as a part of selling, general and administrative expenses in the unaudited condensed consolidated statement of operations.

There wereno impairments recorded during the three and six months ended June 30, 2025 and 2024.

Accrued expenses and other liabilities

Accrued expenses and other liabilities consisted of the following at June 30, 2025 and December 31, 2024:

Schedule of accrued expenses and other liabilities
June 30,December 31,
20252024
Accrued compensation and related liabilities$2,715,202$3,116,301
Accrued development expenses392,747482,417
Accrued warranty reserves425,616692,404
Accrued other expenses334,0354,719
Accrued expenses and other liabilities$3,867,600$4,295,841

Changes in accrued warranty reserves were as follows for the three and six months ended June 30, 2025 and 2024:

Schedule of warranty
Three Months Ended · Six Months Ended
June 30, · June 30,
2025 · 2024 · 2025 · 2024
Beginning of period$525,901$789,931$692,404$826,924
Warranty reserve accrued during the period17,109-17,109-
Settlement of warranty claims(107,208)(40,356)(273,711)(77,349)
End of period$435,802$749,575$435,802$749,575
Warranty reserve - current$425,616$749,575$425,616$749,575
Warranty reserve - noncurrent$10,186$-$10,186$-

Note 6 – Leases

The Company has an operating lease for its corporate headquarters and laboratory space, located in Sunnyvale, California. The initial lease expired June 30, 2024, with an option to extend the lease an additional sixty-months, which was used in the calculation of the right of use operating lease asset and operating lease liability. The Company held no other lease agreements at December 31, 2024. In January 2024, the Company signed an addendum to the operating lease, extending the expiration of the lease through June 30, 2025, and adjusting the monthly rent from $35,606 per month to $50,000 per month. The January 2024 lease remeasurement resulted in a $1,169,822 reduction in the right of use operating lease asset and corresponding reduction to operating lease liability. In March 2024, the Company signed an additional addendum to the operating lease, extending the expiration of the lease through December 31, 2025. The March 2024 lease remeasurement resulted in a $261,012 increase in the right of use operating lease asset and corresponding increase in operating lease liability. In July 2024, the Company signed an additional addendum to the operating lease, extending the expiration of the lease through December 31, 2026. The July 2024 lease remeasurement resulted in a $498,013 increase in the right of use operating lease asset and corresponding increase in operating lease liability. In April 2025, the Company signed an addendum to lease additional office space on a short-term basis in an adjacent office space. The Company accounted for the modification as a separate contract, and will recognize associated lease payments in net income over the lease term.

In January 2025, the Company executed an operating lease for its new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California. The term of the lease commenced on January 17, 2025, the date on which the landlord made the property available to the Company for the purpose of constructing leasehold improvements that will remain the property of the Company during lease term. As a result of entering into this lease agreement, the Company recorded a right-of-use asset and corresponding lease liability of $12,837,535, net of the tenant improvement allowance of $4,090,880 on the commencement date. The lease payments begin on the later of: (i) June 1, 2025; or (ii) the date the tenant improvements are deemed complete, which is expected to be January 2026. The monthly base rent payment is $52,000 in year one; $80,340 in year two; $110,334 in year three; $145,282 in year four; and increasing 3% annually thereafter. The lease provides for a term of 132 months and includes an option to extend the lease for an additional five years, which was used in the calculation of the right of use asset and lease liability, as the Company is reasonably certain that the option will be exercised. The Company determined the probability of the exercise of a lease extension option based on its long-term strategic business outlook, significant leasehold improvements that are expected to have significant economic value to the Company, and costs relating to signing a new lease, among other factors.

Amounts reported in the unaudited condensed consolidated balance sheets for operating leases in which the Company is the lessee as of June 30, 2025 and December 31, 2024, were as follows:

Schedule of operating leases
June 30,December 31,
20252024
Right of use operating lease asset$13,183,580$929,243
Lease liability, current846,721522,525
Lease liability, noncurrent14,766,626574,777
Weighted-average remaining lease term15.58 years2.00 years
Weighted-average discount rate6.45%10.00%

The following table presents the components of lease costs in our unaudited statements of operations for three and six month ended June 30, 2025 and 2024:

Schedule of lease costs
Three Months Ended · Six Months Ended
June 30,June 30,
2025202420252024
Operating lease costs$579,610$114,988$1,151,836$215,971
Variable lease costs33,00033,61966,00064,330
Short-term lease costs3,560-12,532-
Total lease expense$616,170$148,607$1,230,368$280,301

Future lease payments for non-cancellable operating leases, net of the tenant improvement allowance as of June 30, 2025, were as follows:

Schedule of non-cancellable operating leases
Years Ending December 31,
2025 (remaining six months)$300,000
20261,224,000
2027964,080
20281,324,003
20291,743,384
Thereafter25,484,420
Total undiscounted lease payments31,039,887
Less: effects of discounting(11,335,660)
Less: tenant improvement allowance(4,090,880)
Total operating lease liabilities$15,613,347

**Note 7 - Notes payable **

At June 30, 2025 and December 31, 2024, notes payable consisted of the following:

Schedule of notes payable
June 30, · December 31,
2025 · 2024
Notes payable, current
Current portion of notes payable$-$37,286
Notes payable, noncurrent
Long-term portion of notes payable41,800,00041,800,000
Less: unamortized deferred loan costs(418,112)(523,291)
Less: unamortized discount(810,447)(1,013,104)
Notes payable, noncurrent, net$40,571,441$40,263,605
Total notes payable, net$40,571,441$40,300,891

The following table presents information regarding the Company’s notes payable principal repayment obligations as of June 30, 2025:

Schedule of maturities notes payable
Years Ending December 31,
2025 (remaining six months) · $ · -
2026-
202741,800,000
Total minimum payments$41,800,000

Runway Growth Finance Corp

On June 30, 2022, the Company entered into a loan and security agreement with Runway Growth Finance Corp. The debt is secured against substantially all assets of the Company, except for the Company’s intellectual property but includes all proceeds from the sale of intellectual property. As of June 30, 2025 and December 31, 2024, the outstanding principal balance was $41,800,000.

Interest on the term loan accrues on the principal amount outstanding at a floating per annum rate equal to the greater of the rate of interest noted in The Wall Street Journal Money Rates section, as the “Prime Rate” or 4.00% plus a margin of 4.9% and is payable monthly in arrears and shall be computed on the basis of a 360-day year for the actual number of days elapsed. The Company is required to make interest only payments from July 2022 to May 2027. The note payable has a maturity date of June 15, 2027, at which time any unpaid interest, outstanding principal balance, and a final payment of 4.5% of the original principal amount borrowed shall be due in full. If the Company repays the loan prior to maturity, the Company will be required to pay a prepayment fee of 0.5% - 1% of the outstanding principal balance. The Company is also required to pay a 3% success fee of the funded principal amount of the term loan at the time of a liquidity event, as defined in the loan and security agreement. The success fee is enforceable within 10 years from the execution date of the agreement.

The Company has accounted for the final payment of $1,800,000 as a discount of the note that will be amortized over the life of the loan using the effective interest method. Amortization of the discount was $102,014 and $100,725 for the three months ended June 30, 2025 and 2024, respectively. Amortization of the discount was $202,657 and $201,201 for the six months ended June 30, 2025 and 2024, respectively. This amount was recorded as additional interest expense in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2025 and December 31, 2024, the note has been shown net of unamortized discounts of $810,447 and $1,013,104, respectively.

The Company incurred loan costs of $998,393, which are being amortized over the life of the loan using the effective interest method. Amortization of loan costs was $52,913 and $52,499 for the three months ended June 30, 2025 and 2024, respectively. Amortization of loan costs was $105,179 and $104,931 for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025 and December 31, 2024, the note has been shown net of unamortized loan costs of $418,112 and $523,291, respectively.

The Company is subject to customary financial and reporting covenants under the loan and security agreement. As of June 30, 2025 and December 31, 2024, the Company was in compliance with all debt covenants.

Bank of America Leasing & Capital, LLC

In March 2024, the Company entered into an equipment purchase agreement for the purchase of software totaling $82,029. The purchase agreement requires 11 equal payments of $7,457 beginning July 1, 2024, through May 1, 2025. As of June 30, 2025 and December 31, 2024, the outstanding principal balance was $0 and $37,286, respectively, and was included in the current portion of notes payable in the unaudited condensed consolidated balance sheets.

**Note 8 – Convertible preferred stock **

As of June 30, 2025 and December 31, 2024,10,000,000 shares of convertible preferred stock were authorized, of whichno shares were issued or outstanding.

**Note 9 – Common stock **

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Company’s board of directors. As of June 30, 2025 and December 31, 2024, no dividends have been declared.

As of June 30, 2025 and December 31, 2024,600,000,000 shares were authorized, of which 449,552,201 shares and 371,076,200 shares, respectively, were outstanding.

The Company completed its initial public offering and began trading on the Australian Securities Exchange (“ASX”) on November 24, 2021, under the symbol “EBR”. The ASX uses an electronic system called CHESS for the clearance and settlement of trades on the ASX. The State of Delaware does not recognize the CHESS system of holding securities or electronic transfers of legal title to shares. To enable companies to have their securities cleared and settled electronically through CHESS, CHESS depository instruments called CDIs are issued. CDIs are units of beneficial ownership in shares and are traded in a manner similar to shares of Australian companies listed on the ASX. The legal title to the shares is held by a depository, CDN, which is a wholly owned subsidiary of the ASX, and is an approved general participant of ASX Settlement.

In May 2025, the Company completed an institutional placement of 55,900,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $33,468,468, net of $2,497,592 of related issuance costs. In June 2025, the Company completed a non-underwritten rights offering to existing stockholders, or Securities Purchase Plan, and issued an additional 20,000,000 CDIs representing the same number of common stock at $0.64 per share, for proceeds of $12,760,947, net of $101,053 of related issuance costs.

Additionally, the Company has reserved the following shares of common stock for issuance as of June 30, 2025:

Schedule of common stock
Conversion of Common Stock warrants19,789,379
2013 Equity Incentive Plan16,571,305
Amended 2021 Equity Incentive Plan37,104,519
Outside of Amended 2021 Equity Incentive Plan1,061,195
Total shares of Common stock reserved for issuance74,526,398

Note 10 – Warrants

Equity classified common stock warrants

The Company has issued warrants to purchase shares of its common stock, which are exercisable any time at the option of the holder until their expiration date. As of June 30, 2025, the weighted-average exercise price of outstanding warrants was $0.57 with a weighted-average remaining contractual life of 4.78 years.

The following warrants were outstanding as of June 30, 2025 and December 31, 2024:

Schedule of warrants outstanding
Shares of Common Stock Issuable for Outstanding Warrants as of
Warrant IssuanceJune 30, 2025December 31, 2024Exercise PriceExpiration Date
October 6, 2015309,278309,278$0.82October 6, 2025
June 30, 201636,38536,385$0.82June 30, 2026
October 30, 20171,950,6071,950,607$0.41October 29, 2027
February 28, 2018234,176234,176$0.82February 28, 2028
August 26, 20194,438,3474,438,347$0.59August 26, 2029
March 13, 20204,423,3894,423,389$0.59March 13, 2030
March 25, 2020441,500441,500$0.14March 24, 2030
February 12, 20211,732,1231,732,123$0.59February 12, 2031
June 25, 20212,887,5182,887,518$0.59June 25, 2031
August 16, 2021224,269224,269$0.59June 25, 2031
October 4, 20213,111,7873,111,787$0.59October 4, 2031
Total19,789,37919,789,379

Note 11 – Stock-based compensation

The Company and its stockholders adopted an equity incentive plan (the “2013 Plan”) in 2013, which reserved shares of the Company’s common stock for the granting of incentive and nonqualified stock options to employees, directors, and consultants. On October 14, 2021, the Company replaced the 2013 Plan with the 2021 Equity Incentive Plan (“2021 Plan”) in connection with its initial public offering, which was then amended by the Board of Directors and approved by the stockholders on March 18, 2025 and May 21, 2025, respectively. Under the amended 2021 Plan,37,104,519 shares of common stock are reserved. The Company may grant options to purchase common stock, stock appreciation rights, restricted stock awards and other forms of stock-based compensation. Stock options generally vest over four years and expire no later than 10 years from the date of grant. The Board of Directors has the authority to select the employees to whom options are granted and determine the terms of each option, including: i) the number of shares of common stock subject to the option; ii) when the option becomes exercisable; iii) the option exercise price, which must be at least 100% of the fair market value of the common stock as of the date of grant; and iv) the duration of the option, which may not exceed 10 years.

As of June 30, 2025, options to purchase a total of 29,210,639 shares of common stock remained outstanding and 7,893,880 shares remain available for grant under the amended 2021 Plan and 1,061,195 remained outstanding outside of the amended 2021 Plan. As of June 30, 2025, options to purchase a total of 16,571,305 shares of common stock remained outstanding under the 2013 Plan. As of June 30, 2025, no shares of common stock remain available for grant under the 2013 Plan.

Stock option activity for the six months ended June 30, 2025, was as follows:

Schedule of stock option activity
SharesWeighted Average Exercise PriceWeighted- Average Remaining Contractual Life (in years)
Outstanding at December 31, 202441,918,671$0.386.88
Granted8,434,8510.88
Cancelled(934,382)0.54
Exercised(2,576,001)0.17
Outstanding at June 30, 202546,843,139$0.487.10
Vested and expected to vest at June 30, 202546,843,139$0.487.10
Exercisable at June 30, 202527,030,350$0.325.67

The fair value of the options granted to employees is estimated on the grant date using the Black-Scholes option valuation model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the volatility of the Company’s common stock, an assumed risk-free interest rate and expected dividends. The Company uses the simplified calculation of expected life and volatility is based on an average of the historical volatilities of the common stock of several publicly traded entities with characteristics similar to those of the Company. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option. The Company uses the straight-line method for expense attribution. The weighted-average grant-date fair values of stock options granted during the six months ended June 30, 2025 and 2024, was $0.56 per share and $0.39 per share, respectively.

The following assumptions were used to calculate the grant-date fair value of employee stock options granted during the six months ended June 30, 2025 and 2024:

Schedule of assumptions used
Six Months Ended June 30,
20252024
Expected term (in years)5.53 - 6.087.00
Expected volatility65.27% - 67.80%66.49% - 67.34%
Expected dividend yield0.00%0.00%
Risk-free interest rate3.93% - 4.47%4.28% - 4.71%

The following table presents classification of stock-based compensation expense within theaccompanying unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024:

Schedule of stock-based compensation expense
Three Months Ended · Six Months Ended
June 30,June 30,
2025202420252024
Research and development$263,599$189,089$507,211$328,024
Selling, general and administrative440,520233,447701,622451,681
Total$704,119$422,536$1,208,833$779,705

At June 30, 2025, there was $8,970,897 of unamortized stock-based compensation cost, related to unvested stock options which is expected to be recognized over a weighted-average period of 3.03 years.

Note 12 – Income taxes

During the three and six months ended June 30, 2025 and 2024, the Company doesnot have an income tax benefit or expense. The Company has historically incurred net operating losses and maintains a full valuation allowance against its net deferred tax assets. Valuation allowances are recorded when the expected realization of the deferred tax assets does not meet a “more likely than not” criterion. Realization of the Company’s deferred tax assets are dependent upon the generation of future taxable income, the amount and timing of which are uncertain.

The Company’s effective tax rate was 0% for the three and six months ended June 30, 2025 and 2024. The difference between the effective tax rate and the federal statutory rate of 21% was primarily due to the full valuation allowance recorded on the Company’s net deferred tax assets, state and foreign tax benefit, research and development tax credit, and other non-deductible expenses.

During the six months ended June 30, 2025, there wereno material changes to the Company’s uncertain tax positions.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We are currently assessing its impact on our consolidated financial statements.

Note 13 – Net loss per share

The following tables sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2025 and 2024:

Schedule of basic and diluted net loss per share
Three Months Ended June 30,Six Months Ended June 30,
2025202420252024
Numerator – basic & diluted:
Net loss attributable to common stockholders, basic and diluted$(11,967,441)$(11,494,688)$(22,521,711)$(20,644,691)
Denominator:
Weighted-average number of shares outstanding, basic and diluted395,862,055308,101,693384,266,036307,762,783
Net loss per share attributable to common stockholders, basic and diluted$(0.03)$(0.04)$(0.06)$(0.07)

The following potentially dilutive shares have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to the Company’s net loss:

Schedule of anti-dilutive shares
June 30,
20252024
Outstanding warrants19,789,37919,789,379
Outstanding stock options46,843,13939,953,154
Total dilutive shares66,632,51859,742,533

Note 14 - Segment information

An operating segment is defined as a component of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s Chief Executive Officer is the CODM. The CODM reviews financial information on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. The Company’s only product is its WiSE CRT System. Thus, the total Company’s consolidated results represent only the results of the WiSE CRT System Segment. The Company currently conducts its operations primarily in the U.S. Operations in countries outside of the U.S. are limited to Australia and Europe and are not significant. Business activity conducted in the U.S and in our international locations is similar in nature and economic characteristics and are consolidated for reporting purposes. As such, management has determined that the Company operates as one operating and reportable segment that is currently focused exclusively on the sales and marketing activities of the Company’s WiSE CRT System.

The Company’s CODM uses revenue and net loss at the consolidated level as the primary measures of the segment’s performance. Segment revenue derived from sales to customers in the United States was $149,494 for the three and six months ended June 30, 2025. The UK revenue was $20,210 for the three and six months ended June 30, 2025. There was no segment revenue recorded during the three and six months ended June 30, 2024. Significant expenses within net loss include costs of goods sold, research and development, and selling general and administrative expenses. Other segment items within net loss include interest income, interest expense, and other (expense) income. In addition to the segment’s expenses that are presented on the unaudited condensed consolidated statement of operations, the information about the segment’s expenses is disaggregated into significant expenses, which are not separately presented on the Company’s unaudited condensed consolidated statement of operations, as included below.

The table below reports information about the segment loss for the three and six months ended June 30, 2025 and 2024:

Schedule of segment information
Three Months Ended · Six Months Ended
June 30, · June 30,
2025 · 2024 · 2025 · 2024
Revenue$169,704$-$169,704$-
Cost of goods sold85,275-85,275-
Gross profit84,429-84,429-
Operating expenses:
Research and development:
Personnel-related expenses4,665,3254,431,8328,848,2308,292,659
Clinical expenses568,117546,066960,721837,724
Quality assurance and regulatory approval expense83,49663,281170,251124,248
Contract manufacturing, materials and components529,7811,992,2111,260,4003,723,549
Facility-related and other expenses104,839438,214130,638894,703
Total research and development expenses5,951,5587,471,60411,370,24013,872,883
Selling, general and administrative expenses:
Personnel-related expenses2,814,9741,203,5315,114,8092,283,553
Professional services expenses1,032,4201,452,9652,116,8191,955,199
Corporate expense638,688447,0001,216,781960,232
Facility-related and other expenses778,723166,8251,179,400244,452
Total selling, general and administrative expense5,264,8053,270,3219,627,8095,443,436
Total operating expenses11,216,36310,741,92520,998,04919,316,319
Loss from operations(11,131,934)(10,741,925)(20,913,620)(19,316,319)
Other (expense) income:
Interest expense(1,430,947)(1,530,447)(2,828,022)(3,034,144)
Interest income613,990778,9401,247,0831,698,924
Other (expense) income, net (a)(18,550)(1,256)(27,152)6,848
Total other (expense) income(835,507)(752,763)(1,608,091)(1,328,372)
Loss before income taxes(11,967,441)(11,494,688)(22,521,711)(20,644,691)
Income tax expense----
Net loss$(11,967,441)$(11,494,688)$(22,521,711)$(20,644,691)
(a)Other (expense) income includes loss on foreign currency and reimbursements of clinical trial expenses.

Note 15 – Commitments and contingencies

Purchase commitments

The Company purchases raw materials, manufacturing equipment, and various services from a variety of vendors. During the normal course of business, in order to manage manufacturing lead times and help ensure an adequate supply of certain items, we enter into agreements with suppliers that either allow us to procure goods and services when we choose or that establish purchase requirements over the term of the agreement. In certain instances, our purchase agreements allow us to cancel, reschedule, or adjust our purchase requirements based on our business needs prior to firm orders being placed. Consequently, only a portion of our purchase commitments are firm and noncancelable. As of June 30, 2025, the Company’s obligations under such arrangements were approximately $13,500,000.

Contingencies

The Company is party to various legal proceedings from time to time. A liability is accrued when a loss is both probable and can be reasonably estimated. Management believes that the probability of a material loss with respect to any currently pending legal proceeding is remote. However, litigation is inherently uncertain, and it is not possible to definitively predict the ultimate disposition of any of these proceedings. The Company does not believe that there are any pending legal proceedings or other loss contingencies that will, either individually or in the aggregate, have a material adverse impact on the Company’s unaudited condensed consolidated financial statements.

Note 16 – Related party transactions

In June 2025, we issued 20,000,000 shares of common stockat $0.64 per share in connection with a non-underwritten rights offering to existing stockholders, or Securities Purchase Plan. Dr. Bronwyn Evans, a member of our Board of Directors, participated in the Securities Purchase Plan and purchased 30,000 CDIs for the aggregate purchase price of $19,293.

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