UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from ___________ to ___________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
| State or Other Jurisdiction of Incorporation or Organization |
I.R.S. Employer Identification No. |
|
| Address of Principal Executive Offices | Zip Code | |
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| Smaller reporting company | |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
Number of shares of common stock outstanding as of August 3, 2026 was
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In particular, statements contained in this Quarterly Report on Form 10-Q, including but not limited to, statements regarding the sufficiency of our cash, our ability to finance our operations and business initiatives and obtain funding for such activities; our future results of operations and financial position, business strategy and plan prospects, or costs and objectives of management for future acquisitions, are forward looking statements. These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “seeks,” “goals,” “estimates,” “predicts,” “potential” and “continue” or similar words. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.
NOTE REGARDING COMPANY REFERENCES
Throughout this Quarterly Report on Form 10-Q, “Lakewood-Amedex,” the “Company,” “we,” “us” and “our” refer to Lakewood-Amedex Biotherapeutics Inc.
FORM 10-Q
TABLE OF CONTENTS
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PART I - FINANCIAL INFORMATION
Item 1. Condensed Unaudited Financial Statements
LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
CONDENSED BALANCE SHEETS
| As of June 30, 2026 |
As of December 31, 2025 |
|||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Investments | ||||||||
| Interest receivable | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use asset | ||||||||
| Property and equipment, net | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Accrued interest – related parties | ||||||||
| Operating lease liability – current portion | ||||||||
| Notes payable – related parties | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability, net of current portion | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Series A convertible preferred stock, voting, $ | ||||||||
| Series B convertible preferred stock, voting, $ | ||||||||
| Series C convertible preferred stock, voting, $ | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock, | ( | ) | ( | ) | ||||
| Total stockholders’ equity (deficit) | ( | ) | ||||||
| Total liabilities and stockholders’ equity (deficit) | $ | $ | ||||||
The accompanying notes are an integral part of these condensed financial statements.
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LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
CONDENSED STATEMENTS OF OPERATIONS
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Depreciation | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income | ||||||||||||||||
| Total other income (expense), net | ( | ) | ( | ) | ( | ) | ||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Basic and diluted net loss per common share | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | ||||||||||||||||
The accompanying notes are an integral part of these condensed financial statements.
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LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (UNAUDITED)
| Series A Preferred Stock |
Series B Preferred Stock |
Series C Preferred Stock |
Common Stock | Additional Paid-in |
Accumulated | Treasury Stock | Total Stockholders’ Equity |
|||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Shares | Amount | (Deficit) | ||||||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2026 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series C Preferred Stock, net of issuance costs of $ | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series A Preferred Stock | ( | ) | ( | ) | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Conversion of Series B Preferred Stock into common stock | - | - | ( | ) | ( | ) | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Series B Preferred Stock accumulated dividends accrued | - | - | - | - | - | - | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Conversion of accrued Series B Preferred Stock dividends into common stock | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||
| Conversion of convertible notes and accrued interest into common stock | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series C Preferred Stock for common stock | - | - | - | - | ( | ) | ( | ) | ( | ) | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Stock issued for professional services | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2026 | $ | $ | $ | $ | $ | $ | ( | ) | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed financial statements.
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LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
CONDENSED STATEMENTS OF CASH FLOWS
| For the Six Months Ended June 30, |
||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Stock-based compensation | ||||||||
| Amortization of right-of-use asset | ||||||||
| Issuance of common stock for professional services | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | ( | ) | ||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses and other current liabilities | ||||||||
| Accrued interest - related parties | ||||||||
| Operating lease liability | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of investments | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of Series C Convertible Preferred Stock, net of issuance costs of $ | ||||||||
| Proceeds from notes payable - related parties | ||||||||
| Proceeds from notes payable – other | ||||||||
| Repayment of notes payable - related parties | ( | ) | ||||||
| Repayment of notes payable - other | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash and cash equivalents | ||||||||
| Cash and cash equivalents - beginning of period | ||||||||
| Cash and cash equivalents - end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid during the six months ended for: | ||||||||
| Interest | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Conversion of convertible notes payable into common stock | $ | $ | ||||||
| Conversion of convertible notes payable accrued interest into common stock | $ | $ | ||||||
The accompanying notes are an integral part of these condensed financial statements.
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LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
Notes to Condensed Financial Statements (Unaudited)
NOTE 1 – ORGANIZATION, BASIS OF PRESENTATION AND LIQUIDITY
Lakewood-Amedex Biotherapeutics Inc. (“Lakewood-Amedex” or the “Company”) is a Nevada corporation headquartered in University Park, Florida. The Company was originally incorporated on July 11, 2006 under the name Nu Pharmas, Inc. and redomiciled from Delaware to Nevada in June 2025.
The Company is a clinical-stage biotechnology company focused on the development of novel antimicrobial therapeutics for the treatment of serious infectious diseases, including infections caused by antibiotic-resistant bacteria. The Company’s product candidates are designed for localized delivery to the site of infection for the treatment of both acute and chronic infectious diseases.
As of June 30, 2026, the Company owned 71 issued patents and had 30 pending patent applications covering its product candidates and related technologies.
The Company’s lead product candidate, Nu-3 (Bisphosphocin® gel formulation), is being developed as a topical antimicrobial therapy for the treatment of infections in diabetic foot ulcers. The Company has completed a Phase 1 safety study and an exploratory Phase 2 clinical trial of Nu-3 and is preparing to start a Phase 2a dose-comparison clinical study to evaluate dosing and administration for the treatment of mildly infected diabetic foot ulcers (“iDFU”). The Company is also continuing preclinical development activities for additional antimicrobial product candidates.
On April 23, 2026, the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol LABT.
Liquidity and Going Concern Considerations
The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, the accompanying financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The Company incurred a net loss of approximately $
During the quarter ended June 30, 2026, the Company completed the issuance of
On April 23, 2026, the Company completed its direct listing on the Nasdaq Capital Market. In connection with the listing, all outstanding convertible promissory notes with an aggregate principal balance of approximately $
5
Management believes that the net proceeds from the Series C Financing, together with the elimination of outstanding debt obligations through the automatic conversions completed in connection with the Nasdaq listing, have significantly strengthened the Company’s balance sheet and improved its near-term liquidity. Based on its current operating plan, management believes these actions are expected to provide sufficient liquidity to fund operations into the first quarter of 2027.
The Company will require additional capital to fund operations beyond that period and to execute its long-term business plan. Accordingly, management intends to pursue additional capital through one or more equity financings, debt financings, strategic partnerships, licensing arrangements, government grants or other financing alternatives. There can be no assurance that such financing will be available on acceptable terms, or at all.
The Company’s Nasdaq listing also provides management with increased access to the public capital markets, which management believes enhances the Company’s ability to pursue future financing opportunities.
Because the Company will require additional financing within one year after the date these condensed financial statements are issued and such financing is not considered probable under the provisions of ASC 205-40, management has concluded that its plans do not alleviate the substantial doubt about the Company’s ability to continue as a going concern.
Interim Financial Information
The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual financial statements.
The condensed balance sheet as of June 30, 2026 and the condensed statements of operations, stockholders’ equity (deficit) and cash flows for the three and six months ended June 30, 2026 and 2025 are unaudited. The balance sheet as of December 31, 2025 has been derived from the audited financial statements as of that date but does not include all disclosures required by U.S. GAAP for annual financial statements. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and related notes as of and for the year ended December 31, 2025 included in the Company’s Registration Statement on Form S-1, as amended.
In the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the Company’s financial condition as of June 30, 2026 and results of its operations and cash flows for the interim periods presented. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the full year ending December 31, 2026 or for any future interim period.
Comparative Amounts
Certain share and per share amounts presented in these condensed financial statements have been retroactively adjusted to reflect the
Upon review of the comparative period amounts, Management determined that the Company had not appropriately reflected the retroactive effect of its one-for-5.92 reverse stock split, which was effective on September 29, 2025, in its previously issued financial statements for the three and six months ended June 30, 2025.
Accordingly, the comparative June 30, 2025 information presented herein has been revised to reflect the reverse stock split on the correct retroactive basis. The correction had no impact on the Company's previously reported total assets, total liabilities, stockholders' equity (deficit), net loss, or cash flows. The correction affected common shares outstanding, loss per share, weighted-average shares outstanding, and certain related equity disclosures. See the additional disclosures in Note 2, "Net Loss per Common Share."
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NOTE 2 –SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of the accompanying unaudited condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the accompanying condensed financial statements and related disclosures. Significant estimates include, but are not limited to, the valuation of stock-based compensation awards, the assessment of deferred tax assets and related valuation allowances, lease-related assumptions, including the determination of the incremental borrowing rate used in measuring lease liabilities and right-of-use assets, and other estimates and assumptions used in the preparation of the accompanying condensed financial statements.
Management bases its estimates on historical experience and on various other factors believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Management reviews its estimates on an ongoing basis, and revisions are recognized in the period in which the facts and circumstances giving rise to the revisions become known.
Concentrations of Credit Risk
The Company maintains cash balances with financial institutions and invests a portion of its excess cash in certificates of deposit that are presented as investments in the accompanying condensed balance sheet. Cash deposits and investments may, from time to time, exceed federally insured limits.
The Company’s investment policy is designed to preserve principal by diversifying investments among multiple financial institutions, with individual certificates generally limited to approximately the applicable Federal Deposit Insurance Corporation (“FDIC”) insurance limits. Management periodically monitors the creditworthiness of the financial institutions holding the Company’s deposits and issuing its certificates of deposit and believes that the Company is not exposed to significant concentrations of credit risk.
Fair Value Measurements
The Company follows the provisions of ASC 820, Fair Value Measurement, which establishes a framework for measuring fair value and expands disclosures about fair value measurements. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
ASC 820 establishes a three-level hierarchy for inputs used in measuring fair value:
| ● | Level 1 – Quoted prices in active markets for identical assets or liabilities. |
| ● | Level 2 – Observable inputs other than quoted prices included within Level 1, including quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets in inactive markets, and other observable market data. |
| ● | Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. |
The carrying amounts of cash and cash equivalents, interest receivable, accounts payable, accrued expenses and other current liabilities approximate fair value because of the short-term nature of these instruments.
At June 30, 2026, the Company held approximately $
There were no transfers between Level 1, Level 2 or Level 3 during the six months ended June 30, 2026 or 2025.
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Preferred Stock
The Company accounts for its preferred stock in accordance with the applicable provisions of ASC 480, Distinguishing Liabilities from Equity, ASC 480-10-S99 and ASC 815, Derivatives and Hedging. Preferred stock that is mandatorily redeemable is classified as a liability. Preferred stock that is conditionally redeemable or redeemable upon events not solely within the Company’s control is classified as temporary equity. Preferred stock that is neither mandatorily redeemable nor conditionally redeemable is classified as permanent equity.
The Company’s outstanding Series C Convertible Preferred Stock is classified within stockholders’ equity because it is not mandatorily redeemable and the Company concluded that its embedded conversion and other features do not require separate accounting as derivative instruments under ASC 815.
Net Loss per Common Share
The Company computes earnings per share (“EPS”) in accordance with ASC 260-10 issued by the Financial Accounting Standards Board.
Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period.
Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Because the Company reported a net loss for each period presented, all potentially dilutive securities were anti-dilutive and, accordingly, diluted net loss per common share equals basic net loss per common share.
The following tables reconcile net loss to net loss attributable to common stockholders:
| For the Three Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Net loss | $ | $ | ||||||
| Series B cumulative dividends | ||||||||
| Net loss attributable to common stockholders | $ | $ | ||||||
| For the Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Net loss | $ | $ | ||||||
| Series B cumulative dividends | ||||||||
| Net loss attributable to common stockholders | $ | $ | ||||||
Subsequent to the filing of the Company's financial statements for the three and six months ended June 30, 2025, management identified an error in the calculation of net loss attributable to common stockholders used in determining basic and diluted loss per share. The error resulted from the omission of undeclared dividends on the Series B Convertible Preferred Stock of $
In addition, the Company did not appropriately reflect the impact of the 1-for-5.92 reverse stock split that became effective on September 29, 2025. In accordance with ASC 260, all share and per-share amounts for periods presented should have been retrospectively adjusted to reflect the reverse stock split. As a result, weighted-average common shares outstanding were previously reported as
8
The following potential dilutive securities were excluded from the computation of diluted net loss per common share because their effect would have been anti-dilutive:
| June 30, 2026 | June 30, 2025 | |||||||
| Series A convertible preferred shares | ||||||||
| Series B convertible preferred shares including the cumulative dividends | ||||||||
| Common stock warrants | ||||||||
| Stock options | ||||||||
| Total potentially dilutive shares | ||||||||
The Company has outstanding Series C convertible preferred shares that are convertible into common stock at a conversion rate determined by the market price of the Company's common stock on the conversion date as described under the terms of the agreement. Because the conversion rate is variable, the number of shares issuable upon conversion cannot be determined until the conversion date. These securities were excluded from the table above and the computation of diluted net loss per share for the period presented because their inclusion would have been anti-dilutive.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development reimbursements are recorded by the Company as a reduction of research and development costs. The Company incurred research and development costs of $
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires public business entities to provide additional disclosures about certain expense captions presented on the face of the income statement, including disaggregation of specified natural expense categories in interim and annual reporting periods. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2024-03 will have on its financial statement disclosures.
In April 2026, the FASB issued ASU 2026-01, Equity (Topic 505): Initial Measurement of Paid-in-Kind Dividends on Equity-Classified Preferred Stock. The amendments establish guidance for the initial measurement of paid-in-kind dividends on equity-classified preferred stock. The amendments are effective for annual reporting periods beginning after December 15, 2026, including interim periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the impact that adoption of this guidance will have on its financial statements and related disclosures.
NOTE 3 – INVESTMENTS
At June 30, 2026, the Company held certificates of deposit with an aggregate carrying value of $
The Company’s investment portfolio consists of multiple bank-issued certificates of deposit purchased through a brokerage account. The certificates of deposit are carried at amortized cost, which approximates fair value due to their relatively short maturities. Accrued interest is recorded separately as interest receivable.
9
Interest earned on the certificates of deposit is recognized as interest income in the accompanying condensed statements of operations. Interest income totaled $
The Company held investments at December 31, 2025.
NOTE 4 – NOTES PAYABLE – RELATED PARTIES
Short-Term Promissory Notes
During February, March and April 2026, the Company issued unsecured short-term promissory notes to certain existing shareholders and a director in the aggregate principal amount of $
On April 21, 2026, following the closing of the Company’s Series C Convertible Preferred Stock financing, all outstanding short-term promissory notes, together with accrued interest thereon, were repaid in full. Accordingly, short-term promissory notes were outstanding as of June 30, 2026.
Convertible Promissory Notes
During May 2025, the Company issued convertible promissory notes in the aggregate principal amount of $
On April 23, 2026, in connection with the Company’s direct listing on the Nasdaq Capital Market, all outstanding convertible promissory notes, together with accrued and unpaid interest totaling approximately $
The Company recorded interest expense related to notes payable of $
NOTE 5 – COMMITMENTS AND CONTINGENCIES
Lease Agreement
On November 3, 2021, the Company signed a lease for new office space which commenced April 15, 2022, at University Park, Florida. The lease has an initial term of
Rent expense was $
10
At June 30, 2026, the remaining lease term and discount rate were
Maturity of operating lease liability at June 30, 2026 is as follows:
| Year Ending December 31, | ||||
| 2026 (remaining) | $ | |||
| 2027 | ||||
| Total lease payments | ||||
| Less: Interest | ( | ) | ||
| Present value of lease liability | $ | |||
Clinical Services Agreements
During the second quarter of 2026, the Company entered into and committed to certain clinical manufacturing and clinical research agreements in support of its planned Phase 2a clinical trial for its Nu-3 topical gel product candidate. Costs incurred under these agreements are recognized as research and development expense as the related services are performed.
In May 2025, the Company received a proposed statement of work from Pace Life Sciences (“Pace”) related to the cGMP clinical manufacturing of the Company’s Nu-3 topical gel product candidate. During 2025, the Company did not commit to the full manufacturing program and was obligated only for limited preliminary supplies that were ordered and paid for during the period.
On April 23, 2026, the Company authorized and committed to proceed with the full clinical manufacturing program with Pace in support of the Company’s planned clinical development activities. Pursuant to the statement of work, Pace will provide cGMP clinical manufacturing services for Nu-3 topical gel-filled applicators, including Phase A – cGMP clinical manufacturing, Phase B – labeling and kitting of Nu-3 applicators, and Phase C – an 18-month International Council for Harmonisation (“ICH”) stability program.
The statement of work provides for fixed contractual fees totaling approximately $
Through June 30, 2026, the Company had incurred costs of approximately $
On April 21, 2026, the Company entered into a Clinical Research Organization Agreement with Professional Education and Research Institute, LLC (“PERI”) in connection with the Company’s planned Phase 2a clinical trial for its iDFU product candidate. Pursuant to the agreement, PERI will provide clinical trial management and operational support services, including study start-up activities, site feasibility and qualification, site contracting and budgeting, institutional review board coordination, project management, clinical monitoring, site management, electronic data capture oversight, data management, database lock and archive activities, and related clinical and data management services.
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The agreement provides for professional service fees totaling approximately $
Through June 30, 2026, the Company had incurred costs of approximately $
Advisory and Placement Agency Agreement
On February 10, 2025, Lakewood-Amedex Biotherapeutics Inc. executed an agreement with RBW Capital Partners LLC (“RBW”), a division of Dawson James Securities, Inc. (the “BD” and together with RBW, the “Placement Agent”) for the provision of financial advisory and financial placement agency and investment banking services, including assistance in connection with the Company’s listing on the Nasdaq Capital Market and related financing activities.
Pursuant to the terms of the agreement, upon closing of a qualified financing transaction, the Company agreed to pay the Placement Agent a cash transaction fee equal to
In connection with the closing of the Company’s Series C Convertible Preferred Stock on April 21, 2026, the Company paid the Placement Agent a cash transaction fee of $
Subsequent to June 30, 2026, the agreement terminated effective August 6, 2026 following the Company’s delivery of written notice on July 8, 2026. The Company has no continuing obligations under the agreement other than those that expressly survive termination.
Legal Proceedings
There are no matters currently outstanding for which any liabilities have been accrued or require disclosure.
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NOTE 6 – STOCKHOLDERS’ EQUITY
Authorized Stock
The Company’s authorized capital stock consists of common stock and preferred stock, each having a par value of $
The holders of the Company’s Common Stock are entitled to
Common Stock
During the six months ended June 30, 2026, the Company completed its financing through the issuance of Series C Convertible Preferred Stock, effected a reverse stock split, and completed the direct listing of its common stock on the Nasdaq Capital Market, resulting in significant changes to the Company’s capital structure.
On June 19, 2026, the Company effected a one-for-ten (1:10) reverse stock split of its common stock (the “2026 Reverse Split”). The 2026 Reverse Split was approved by the Board of Directors on June 1, 2026 and became effective upon the filing of Articles of Amendment to the Company’s Articles of Incorporation with the Nevada Secretary of State. The amendment effected both the one-for-ten reverse split of the Company’s common stock and a proportional reduction in the number of authorized shares of common stock. The number of authorized shares of preferred stock was not affected.
The 2026 Reverse Split was implemented in accordance with the requirements of the Securities Purchase Agreement governing the Company’s Series C Convertible Preferred Stock.
Each reverse stock split affected the Company’s issued and outstanding shares of common stock, treasury shares, stock options, warrants and all other securities exercisable for or convertible into common stock on a proportionate basis. No fractional shares were issued in connection with either reverse stock split. Fractional interests resulting from either reverse stock split were rounded up to the nearest whole share.
All share and per-share amounts presented in these condensed consolidated financial statements and the accompanying notes have been retroactively adjusted to give effect to both the 2025 Reverse Split and the 2026 Reverse Split for all periods presented. The par value of the Company’s common stock and preferred stock was not affected by either reverse stock split.
During the three months ended June 30, 2026, the Company issued
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Reserved Shares
As of June 30, 2026, the Company has reserved the following shares of common stock for future issuance:
| Shares reserved for future issuance under the 2020 Equity Incentive Plan | ||||
| Stock options outstanding | ||||
| Warrants outstanding | ||||
| Issuance upon conversion of Series C Convertible Preferred Stock | ||||
| Total |
Preferred Stock
The Company is authorized to issue a total of
Series A and Series B Convertible Preferred Stock
Immediately prior to the Company’s direct listing on the Nasdaq Capital Market on April 23, 2026, all outstanding shares of Series A Preferred and Series B Preferred automatically converted into shares of the Company’s common stock in accordance with their respective Certificates of Designation.
Following the 2026 Reverse Split, the Series A Preferred converted into
Following the automatic conversions, no shares of Series A Preferred or Series B Preferred remained issued or outstanding, and all associated conversion rights, dividend rights and liquidation preferences terminated.
Series C Convertible Preferred Stock
On April 21, 2026, the Company completed the issuance of
The Series C Preferred has an aggregate stated value of $
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Each share of Series C Preferred has a stated value of $
| ● | $ |
| ● |
The conversion price is subject to customary adjustments for stock splits, stock dividends, recapitalizations and similar transactions, including the 2026 Reverse Split, as well as certain anti-dilution adjustments provided in the Certificate of Designation.
Conversion is subject to a
Holders of the Series C Preferred are entitled to cumulative dividends at the rate of
Upon any liquidation, dissolution or winding up of the Company, or upon the occurrence of a Deemed Liquidation Event (as defined in the Certificate of Designation), holders of the Series C Preferred are entitled to receive, prior to any distribution to holders of common stock, the greater of (i) the stated value of the Series C Preferred or (ii) the amount that would have been payable had the Series C Preferred been converted into common stock immediately prior to such event.
The Company evaluated the accounting treatment of the Series C Preferred pursuant to ASC 480, Distinguishing Liabilities from Equity, ASC 480-10-S99 and ASC 815, Derivatives and Hedging. The Company concluded that the Series C Preferred is appropriately classified as permanent equity because it is not mandatorily redeemable and any deemed liquidation events are within the Company’s control. The Company further concluded that none of the embedded features require bifurcation as derivative instruments under ASC 815. Accordingly, the Series C Preferred is classified within stockholders’ equity, net of issuance costs.
In connection with the financing, the Company entered into a Registration Rights Agreement pursuant to which it agreed to file a registration statement covering the resale of the shares of common stock issuable upon conversion of the Series C Preferred. During the quarter ended June 30, 2026, the Company filed the required registration statement with the Securities and Exchange Commission.
NOTE 7 – STOCK-BASED COMPENSATION
In November 2020, the Company adopted the 2020 Equity Incentive Plan (the “2020 Plan”), which became effective in January 2021. The 2020 Plan provides for the grant of stock options and restricted stock awards to employees, directors and non-employee service providers.
Awards granted under the 2020 Plan expire no later than ten years from the date of grant. The exercise price of incentive stock options and nonqualified stock options granted under the 2020 Plan may not be less than 100% of the fair market value of the Company’s common stock on the date of grant. Awards generally vest over a four-year service period, although awards may be granted with different vesting provisions. The 2020 Plan initially reserved
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Stock Options
stock options were granted during the three and six months ended June 30, 2026 or 2025.
The Company recognizes stock-based compensation expense related to stock options on a straight-line basis over the requisite service periods of each award. As of June 30, 2026, total unrecognized stock-based compensation expense related to unvested stock options was approximately $
As of June 30, 2026, options to purchase an aggregate of
Warrants
On April 24, 2026, the Company issued a warrant to purchase
The Company determined the grant-date fair value of the warrant using the Black-Scholes option pricing model. The resulting fair value is recognized as stock-based compensation expense on a straight-line basis over the requisite service period. As of June 30, 2026, unrecognized stock-based compensation expense related to the unvested director warrant was approximately $
No warrants were exercised, expired, or forfeited during the three and six months ended June 30, 2026 and 2025.
As of June 30, 2026, warrants to purchase an aggregate of
Summary of Stock-Based Compensation Expense
The following table presents stock-based compensation expense recognized in the accompanying condensed statements of operations:
| For the Three Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total | $ | $ | ||||||
| For the Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total | $ | $ | ||||||
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NOTE 8 – SEGMENT REPORTING
The Company operates as a operating segment focused on development of novel antimicrobial therapies.
In addition to total assets and actual expenses, the CODM regularly receives disaggregated information regarding research and development expenses, general and administrative expenses, and other segment expenses. Other segment expenses include depreciation and interest expense and are presented net of interest income and other income.
The following tables present the significant expense categories reviewed by the CODM:
| For the Three Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Research and Development | ||||||||
| Personnel | $ | $ | ||||||
| Clinical and preclinical activities | ||||||||
| Other | ||||||||
| Total research and development | ||||||||
| General and Administrative | ||||||||
| Professional services | ||||||||
| Personnel | ||||||||
| Corporate expenses | ||||||||
| Facility costs | ||||||||
| Total general and administrative | ||||||||
| Other Segment (Income) Expenses | ( | ) | ||||||
| Net Loss | $ | $ | ||||||
| For the Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Research and Development | ||||||||
| Personnel | $ | $ | ||||||
| Clinical and preclinical activities | ||||||||
| Other | ||||||||
| Total research and development | ||||||||
| General and Administrative | ||||||||
| Professional services | ||||||||
| Personnel | ||||||||
| Corporate expenses | ||||||||
| Facility costs | ||||||||
| Total general and administrative | ||||||||
| Other Segment Expenses | ||||||||
| Net Loss | $ | $ | ||||||
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NOTE 9 – INCOME TAXES
The provision for income taxes for interim periods is determined, in accordance with ASC 740-270, Income Taxes—Interim Reporting, using an estimated annual effective tax rate, adjusted for discrete items recognized during the period, if any. Because the Company has historically incurred operating losses and maintains a full valuation allowance against its deferred tax assets, no income tax provision or benefit has been recognized for the periods presented. The estimated annual effective tax rate remains subject to change based on future operating results, changes in valuation allowances against deferred tax assets, changes in tax laws or their interpretation, and the recognition or derecognition of uncertain tax positions, if any.
Due to the Company’s cumulative operating losses and resulting full valuation allowance against its deferred tax assets, the Company did not record an income tax provision or benefit for the three and six months ended June 30, 2026 and 2025. Management has concluded that it is more likely than not that the Company’s deferred tax assets will not be realized.
The Company recognizes interest and penalties related to uncertain tax positions, if any, as a component of income tax expense. As of June 30, 2026 and December 31, 2025, the Company had unrecognized tax benefits and had accrued any interest or penalties related to uncertain tax positions.
NOTE 10 – SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date the financial statements were issued. Based on this evaluation, except for the matters disclosed in Note 5, there were no material subsequent events requiring recognition or additional disclosure in the accompanying condensed financial statements.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis is intended as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with our unaudited condensed financial statements and the notes presented herein included in this Form 10-Q and the audited financial statements and the other information set forth in the S-1 registration statement recently filed with the SEC. ln addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein. Our actual results could differ significantly from those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed and to be filed with the Securities and Exchange Commission.
Overview
Lakewood-Amedex Biotherapeutics Inc. is a clinical-stage biotechnology company focused on the development of novel antimicrobial therapeutics for the treatment of serious infectious diseases, including infections caused by antibiotic-resistant bacteria. The Company’s lead product candidate, Nu-3 (Bisphosphocin® gel formulation), is being developed as a topical antimicrobial therapy for the treatment of iDFU. The Company is currently advancing preparations for a Phase 2a dose-comparison clinical study while continuing to develop its broader antimicrobial technology platform.
The three months ended June 30, 2026 represented a significant milestone in the Company’s evolution. During the quarter, the Company completed a private placement of its Series C Convertible Preferred Stock, generating approximately $7.5 million in gross proceeds, completed the listing of its common stock on the Nasdaq Capital Market, and substantially simplified its capital structure through the conversion of its outstanding preferred stock and convertible debt into common stock. These transactions significantly strengthened the Company’s balance sheet, enhanced its liquidity, and positioned the Company to advance its clinical development strategy.
Following the financing and Nasdaq listing, management’s primary focus shifted from capital formation to execution of the Company’s clinical development objectives. During the quarter, the Company expanded activities supporting its planned Phase 2a clinical study, including manufacturing, regulatory, and clinical planning activities necessary to advance Nu-3 toward its next stage of development. As a result, research and development expenses increased compared to the prior-year period. General and administrative expenses also increased significantly, primarily reflecting stock-based compensation, professional fees, advisory services, investor relations activities, legal and accounting costs, and other expenses associated with becoming a Nasdaq-listed public company.
The Company has incurred recurring operating losses since inception and expects to continue incurring losses as it advances the clinical development of Nu-3 and its other product candidates. While the capital raised during the quarter significantly improved the Company’s liquidity and provides financial resources to execute its near-term operating plans, the Company expects that additional capital will be required to complete clinical development, pursue regulatory approvals, and support commercialization activities. Management intends to continue evaluating a variety of financing alternatives to support the Company’s long-term strategic objectives.
Recent Developments
Series C Financing
On April 21, 2026, the Company completed a private placement of its Series C Convertible Preferred Stock, raising approximately $6.8 million in net proceeds. The financing significantly strengthened the Company’s capital resources and provided funding to support the advancement of its clinical development programs, including preparations for the planned Phase 2a clinical study of Nu-3 in iDFU. The financing also enabled the Company to satisfy key conditions necessary for its subsequent listing on the Nasdaq Capital Market.
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Nasdaq Listing
On April 23, 2026, the Company’s common stock commenced trading on the Nasdaq Capital Market. Management believes the Nasdaq listing represents a significant milestone in the Company’s development by increasing its visibility within the investment community, broadening access to the public capital markets, and enhancing its ability to pursue future financing opportunities to support its long-term growth strategy.
Simplification of Capital Structure
In connection with the Nasdaq listing, all outstanding shares of the Company’s Series A and Series B Convertible Preferred Stock, together with the Company’s outstanding convertible promissory notes and related accrued interest, automatically converted into shares of common stock pursuant to their respective terms. These conversions significantly simplified the Company’s capital structure by eliminating multiple classes of convertible securities and reducing future financing complexity.
Reverse Stock Split
On June 19, 2026, the Company effected a one-for-ten reverse stock split of its issued and outstanding common stock. The reverse stock split was implemented to satisfy the capital structure requirements associated with the Company’s financing transactions and Nasdaq listing. All share and per-share amounts presented in this Quarterly Report have been retroactively adjusted to give effect to the reverse stock split.
Advancement of Clinical Development
Following completion of the financing and Nasdaq listing, the Company accelerated activities supporting the advancement of Nu-3 (Bisphosphocin® gel formulation) toward its planned Phase 2a clinical study. During the quarter, the Company continued manufacturing, regulatory, and clinical planning activities and entered into agreements with third-party service providers to support future clinical development. These activities contributed to the increase in research and development expenditures during the quarter as the Company transitioned from financing activities to execution of its clinical development strategy.
Strengthened Financial Position
As a result of the financing transactions completed during the quarter, the Company substantially improved its liquidity and working capital position. At June 30, 2026, the Company held cash, cash equivalents, and certificates of deposit sufficient to support its near-term operating objectives of less than 12 months. Although management believes the Company’s current capital resources will enable it to continue advancing its clinical development plans, the Company expects that additional financing will ultimately be required to complete the development of its product candidates, obtain regulatory approvals, and support future commercialization activities.
Results of operations
Comparison of the three months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:
| Three months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Revenue | $ | — | $ | — | $ | — | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 503,020 | $ | 146,901 | 356,119 | ||||||||
| General and administrative | 3,285,481 | 489,325 | 2,796,156 | |||||||||
| Depreciation | 1,159 | 1,158 | 1 | |||||||||
| Total operating expenses | 3,789,660 | 637,384 | 3,152,276 | |||||||||
| Loss from operations | (3,789,660 | ) | (637,384 | ) | (3,152,276 | ) | ||||||
| Other income (expense), net: | ||||||||||||
| Interest income | 28,285 | 5,390 | 22,895 | |||||||||
| Interest expense | (10,633 | ) | (23,949 | ) | 13,316 | |||||||
| Total other income (expense), net | 17,652 | (18,559 | ) | 36,211 | ||||||||
| Net loss | $ | (3,772,008 | ) | $ | (655,943 | ) | $ | (3,116,065 | ) | |||
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Research and development expenses
The following table summarizes our R&D expenses for the three months ended June 30, 2026 and 2025:
| Three months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Personnel-related expenses | $ | 265,815 | $ | 137,609 | $ | 128,206 | ||||||
| Clinical and pre-clinical expenses | 230,875 | 5,662 | 225,213 | |||||||||
| Other expenses | 6,330 | 3,630 | 2,700 | |||||||||
| Total research and development expenses | $ | 503,020 | $ | 146,901 | $ | 356,119 | ||||||
Research and development expenses increased approximately $356 thousand, or 242%, to $503 thousand for the three months ended June 30, 2026, compared to $147 thousand for the comparable period in 2025.
Personnel-related expenses increased approximately $128 thousand, primarily reflecting increased compensation and stock-based compensation as the Company expanded activities to support its clinical development programs and the partial restoration of previously reduced executive compensation. The increase in clinical and pre-clinical expenses was primarily attributable to a $225 thousand increase expenses associated with manufacturing, regulatory, and other activities supporting the Company’s planned Phase 2a clinical study of Nu-3 in iDFU, which had previously been put on hold while the Company completed its financing and Nasdaq listing. Other research and development expenses remained relatively consistent with the prior-year period.
General and administrative expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2026 and 2025:
| Three months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Professional services | $ | 2,819,556 | $ | 268,640 | $ | 2,550,916 | ||||||
| Personnel-related expenses | 244,065 | 116,922 | 127,143 | |||||||||
| Corporate expenses | 182,260 | 66,262 | 115,998 | |||||||||
| Facility costs | 39,600 | 37,501 | 2,099 | |||||||||
| Total general and administrative expenses | $ | 3,285,481 | $ | 489,325 | $ | 2,796,156 | ||||||
General and administrative expenses increased approximately $2.8 million, or 571%, to $3.3 million for the three months ended June 30, 2026, compared to $489 thousand for the comparable period in 2025.
The increase was primarily attributable to approximately $2.6 million increase in professional services, principally reflecting approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services. The remaining increase in professional services primarily reflects higher Nasdaq listing and compliance costs, patent-related legal fees, audit and accounting fees, and other professional fees associated with the Company’s transition to operating as a Nasdaq-listed public company.
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Personnel-related expenses increased approximately $127 thousand, primarily reflecting increased stock-based compensation and compensation, including changes in executive compensation allocations and the partial restoration of previously reduced executive compensation. Corporate expenses increased approximately $116 thousand, primarily due to higher directors’ and officers’ insurance premiums, investor relations activities, and other public company operating costs. Facility costs remained substantially consistent with the prior-year period.
Other income (expense), net
Other income, net was approximately $18 thousand for the three months ended June 30, 2026, compared to other expense, net of approximately $19 thousand for the comparable period in 2025, representing a favorable change of approximately $36 thousand.
The improvement was primarily attributable to approximately $23 thousand increase in interest income resulting from higher average cash balances following completion of the Company’s Series C financing, together with approximately $13 thousand decrease in interest expense resulting from the automatic conversion of the Company’s outstanding convertible promissory notes into common stock upon the Company’s Nasdaq listing. As a result, the Company generated net other income during the 2026 period compared with net other expense during the comparable prior-year period.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
| Six months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Revenue | $ | — | $ | — | $ | — | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 685,167 | $ | 316,605 | 368,562 | ||||||||
| General and administrative | 3,988,926 | 861,071 | 3,127,855 | |||||||||
| Depreciation | 2,317 | 2,317 | — | |||||||||
| Total operating expenses | 4,676,410 | 1,179,993 | 3,496,417 | |||||||||
| Loss from operations | (4,676,410 | ) | (1,179,993 | ) | (3,496,417 | ) | ||||||
| Other income (expense), net: | ||||||||||||
| Interest income | 29,363 | 9,697 | 19,666 | |||||||||
| Interest expense | (48,852 | ) | (25,264 | ) | (23,588 | ) | ||||||
| Other income | 600 | — | 600 | |||||||||
| Total other (expense), net | (18,889 | ) | (15,567 | ) | (3,322 | ) | ||||||
| Net loss | $ | (4,695,299 | ) | $ | (1,195,560 | ) | $ | (3,499,739 | ) | |||
Research and development expenses
The following table summarizes our R&D expenses for the six months ended June 30, 2026 and 2025:
| Six months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Personnel-related expenses | $ | 428,599 | $ | 280,233 | $ | 148,366 | ||||||
| Clinical and pre-clinical expenses | 246,608 | 29,112 | 217,496 | |||||||||
| Other expenses | 9,960 | 7,260 | 2,700 | |||||||||
| Total research and development expenses | $ | 685,167 | $ | 316,605 | $ | 368,562 | ||||||
Research and development expenses increased approximately $369 thousand, or 116%, to $685 thousand for the six months ended June 30, 2026, compared to approximately $317 thousand for the comparable period in 2025.
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Personnel-related expenses increased approximately $148 thousand, primarily due to increased compensation and stock-based compensation associated with expanded research and development activities and the partial restoration of previously reduced executive compensation. The clinical and pre-clinical expenses increase primarily reflects approximately $217 thousand increase in expenses associated with manufacturing, regulatory, and clinical development activities supporting the Company’s planned Phase 2a clinical study of Nu-3 in iDFU, which had previously been put on hold while the company completed its financing and Nasdaq listing. Other research and development expenses remained substantially consistent with the prior-year period.
General and administrative expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025:
| Six months ended June 30, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Professional services | $ | 3,247,071 | $ | 470,128 | $ | 2,776,943 | ||||||
| Personnel-related expenses | 390,905 | 189,049 | 201,856 | |||||||||
| Corporate expenses | 274,333 | 126,794 | 147,539 | |||||||||
| Facility costs | 76,617 | 75,100 | 1,517 | |||||||||
| Total general and administrative expenses | $ | 3,988,926 | $ | 861,071 | $ | 3,127,855 | ||||||
General and administrative expenses increased approximately $3.1 million, or 363%, to approximately $4.0 million for the six months ended June 30, 2026, compared to approximately $861 thousand for the comparable period in 2025.
The increase was primarily attributable to approximately $2.8 million increase in professional services, principally reflecting approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services. The remaining increase in professional services primarily reflects higher Nasdaq listing and compliance costs, patent-related legal fees, audit and accounting fees, and other professional fees associated with the Company’s transition to operating as a Nasdaq-listed public company and compliance with its ongoing SEC reporting obligations.
Personnel-related expenses increased approximately $202 thousand, primarily reflecting higher stock-based compensation and compensation, including changes in executive compensation allocations. Corporate expenses increased approximately $148 thousand, primarily due to increased directors’ and officers’ insurance, investor relations activities, Nasdaq listing fees, and other public company operating costs. Facility costs remained substantially unchanged from the comparable prior-year period.
Other income (expense), net
Other expense, net was approximately $19 thousand for the six months ended June 30, 2026, compared to approximately $16 thousand for the comparable period in 2025.
Interest income increased approximately $20 thousand as a result of higher average cash balances following completion of the Series C financing. Interest expense increased approximately $24 thousand, primarily reflecting interest incurred on convertible promissory notes outstanding prior to their automatic conversion into common stock upon the Company’s Nasdaq listing.
Liquidity and Capital Resources
Since inception, the Company has financed its operations primarily through the issuance of equity securities and convertible debt. The Company has incurred recurring operating losses and negative cash flows from operations as it has advanced the development of its product candidates. At June 30, 2026, the Company had $2.6 million in cash and cash equivalents, $2.0 million in certificates of deposit, and working capital of approximately $4.2 million, compared to $236 thousand in cash and cash equivalents and a working capital deficit of approximately $2.1 million at December 31, 2025.
The significant improvement in the Company’s liquidity and financial position during the six months ended June 30, 2026 was primarily attributable to the completion of its Series C Convertible Preferred Stock financing, which generated net proceeds of approximately $6.8 million. In addition, the automatic conversion of the Company’s outstanding Series A and Series B Convertible Preferred Stock and convertible promissory notes into common stock in connection with the Nasdaq listing significantly reduced current liabilities and simplified the Company’s capital structure.
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The Company continues to invest in the advancement of Nu-3 (Bisphosphocin® gel formulation), including manufacturing, regulatory, and clinical development activities supporting its planned Phase 2a clinical study. Management believes that the Company’s existing cash, cash equivalents, investments, and anticipated interest income will be sufficient to fund its currently planned operating activities for the foreseeable future of less than 12 months. Nevertheless, because the Company expects to continue incurring operating losses as it advances the clinical development of its product candidates, additional capital will ultimately be required to complete clinical development, obtain regulatory approvals, and support future commercialization activities. Management intends to continue evaluating a variety of financing alternatives, including equity financings, strategic collaborations, licensing arrangements, and other sources of capital to support the Company’s long-term business objectives.
Cash flows
For the six months ended June 30, 2026 and 2025
The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
| For the Six Months Ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Net cash used in operating activities | $ | (2,453,721 | ) | $ | (912,643 | ) | ||
| Net cash used in investing activities | (2,000,000 | ) | — | |||||
| Net cash provided by financing activities | 6,802,095 | 1,500,000 | ||||||
| Net increase in cash and cash equivalents | $ | 2,348,374 | $ | 587,357 | ||||
Operating Activities
Net cash used in operating activities increased to approximately $2.5 million for the six months ended June 30, 2026 from approximately $913 thousand for the comparable period in 2025. The increase primarily reflects expanded operating activities associated with the Company’s clinical development programs and increased costs incurred in connection with operating as a Nasdaq-listed public company. Cash used in operating activities was partially offset by significant noncash charges, including approximately $2.4 million of noncash professional service expense recognized in connection with the issuance of common stock for placement agent advisory services, as well as stock-based compensation and other noncash expenses.
Investing Activities
Net cash used in investing activities was approximately $2.0 million for the six months ended June 30, 2026, compared to no investing activities during the comparable prior-year period. Investing activities consisted primarily of the purchase of certificates of deposit using a portion of the proceeds received from the Company’s Series C Convertible Preferred Stock financing. These investments were made to earn interest on excess cash while preserving liquidity to support the Company’s planned operating activities.
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Financing Activities
Net cash provided by financing activities was approximately $6.8 million for the six months ended June 30, 2026, compared to $1.5 million for the comparable period in 2025. Financing activities during the 2026 period consisted primarily of the net proceeds received from the issuance of the Company’s Series C Convertible Preferred Stock. Financing activities during the comparable 2025 period consisted primarily of proceeds received from convertible promissory notes used to fund the Company’s operations.
Material Cash Requirements
The Company’s material cash requirements consist primarily of expenditures to support its clinical development programs, personnel costs, professional services, facility lease obligations, and general corporate operating expenses.
Operating Lease
The Company leases office space in University Park, Florida, under a non-cancelable operating lease that expires on April 30, 2027. The Company expects to satisfy its lease obligations through cash generated from its existing liquidity resources. Additional information regarding the Company’s lease commitments is included in Note 5 to the condensed financial statements included elsewhere in this Quarterly Report.
Research and Development Commitments
The Company expects to continue to incur significant expenditures related to the development of Nu-3 (Bisphosphocin® gel formulation), including manufacturing, regulatory, clinical trial, and other development activities associated with its planned Phase 2a clinical study. The Company has entered into agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), laboratories, and other third-party service providers to support these activities. The timing and amount of future payments under these arrangements will depend on the progress of clinical development and other research activities. Additional information regarding the Company’s research and development commitments is included in Note 5 to the condensed financial statements included elsewhere in this Quarterly Report.
Public Company Costs
As a Nasdaq-listed public company, the Company expects to continue to incur increased costs associated with SEC reporting, Nasdaq listing fees, legal and accounting services, directors’ and officers’ insurance, investor relations, and other corporate governance and compliance requirements. Management expects these expenditures to remain higher than historical levels as the Company continues to operate as a public reporting company.
The Company expects to fund these cash requirements through its existing cash, cash equivalents, short-term investments and, as necessary, future financing activities.
Critical Accounting Policies and Estimates
The preparation of our condensed financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
There have been no material changes to the Company’s critical accounting policies and estimates from those described in the Company’s Registration Statement on Form S-1 (File No. 333-292664), as amended, during the six months ended June 30, 2026.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk.
We do not hold any derivative instruments and do not engage in any hedging activities.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission (“SEC”). These disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to the Company’s management, including its Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), as appropriate, to allow timely decisions regarding required disclosure.
As of June 30, 2026, management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures, as required by Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, management concluded that the Company’s disclosure controls and procedures were not effective as of June 30, 2026 due to the material weaknesses in internal control over financial reporting described below.
The material weaknesses identified by management include the following:
| ● | Limited documentation of the Company’s system of internal control over financial reporting, including formal control policies and procedures. |
| ● | Limited segregation of duties in the handling of cash receipts, cash disbursements and other accounting functions due primarily to the Company’s limited number of employees. |
| ● | Insufficient management review controls over significant accounting areas, including investments, earnings per share, stock-based compensation, income taxes and right-of-use lease accounting. |
| ● | Information technology general controls that were not designed and operating effectively to appropriately restrict access to applications and data, maintain appropriate segregation of duties, and monitor changes to financial information. |
The material weaknesses described above are the same material weaknesses previously disclosed in the Company’s Registration Statement on Form S-1 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. The Company continues to evaluate and implement remediation measures intended to address these material weaknesses, including enhancing documentation and review procedures, strengthening access and monitoring controls, and utilizing external consultants and other resources where appropriate. Because of the Company’s limited personnel and financial resources, remediation efforts are expected to be implemented over time. While management is committed to strengthening the Company’s internal control environment, there can be no assurance regarding the timing of remediation or whether the implemented measures will fully remediate the identified material weaknesses.
Notwithstanding the material weaknesses described above, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that unaudited condensed financial statements, and other financial information included in this quarterly report, fairly present in all material respects our financial condition, results of operations, and cash flows as of and for the periods presented in this quarterly report.
Changes in Internal Controls
There were no changes in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, as of 1934, as amended) during the fiscal quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II-OTHER INFORMATION
Item 1. Legal Proceedings.
There are no actions, suits, proceedings, inquiries or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our company or any of our subsidiaries, threatened against or affecting our company, our common stock, any of our subsidiaries or of our companies or our subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.
Item 1A. Risk Factors.
Not required because we are a smaller reporting company.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
| (a) | Unregistered Sales of Equity Securities |
On January 31, 2026, we entered into a securities purchase agreement with an accredited investor, pursuant to which we sold, an aggregate of 937,500 shares of Series C Convertible Preferred Stock in a private placement exempt from registration pursuant to Rule 506(b) of Regulation D under the Securities Act. The Series C Convertible Preferred Stock has an aggregate stated value of $9.375 million, and the investor purchased the shares for an aggregate purchase price of $7.5 million, representing a 20% original issue discount.
The financing closed on April 21, 2026, resulting in net proceeds to the Company of approximately $6.8 million after payment of placement agent fees and other offering-related expenses. Through June 30, 2026, the holder converted an aggregate of 440,343 shares of Series C Convertible Preferred Stock into shares of the Company’s common stock in accordance with the terms of the Certificate of Designation. As of June 30, 2026, 497,157 shares of Series C Convertible Preferred Stock remained outstanding.
In accordance with the securities purchase agreement, we amended our articles and filed a certificate of designation to create a new class of Series C Preferred Stock, with an authorized number of 937,500 shares, with the following terms.
The Series C Preferred Stock has a stated value of $10.00 per share and is convertible into Common Stock in an amount determined by the stated value divided by the conversion price.
The conversion price is equal to the lower of (i) $10.00 (the “Fixed Price”), or (ii) 80% of the lowest closing sale price of the Common Stock during the five consecutive trading days immediately preceding the conversion date or other date of determination (the “Variable Price”), but which Variable Price will not be lower than the floor price of $1.00 (the “Floor Price”). The conversion price will be subject to certain adjustments, including if we sell Common Stock at a price lower than the Fixed Price, and in the event of stock splits, stock dividends, and similar transactions (provided that the Fixed Price will not exceed $10.00 and the Floor Price will not exceed $1.00). The Series C Preferred Stock cannot be converted to Common Stock to the extent such conversion would cause the holder to beneficially own more than 4.99% of our outstanding Common Stock.
Holders of Series C Preferred Stock are entitled to receive, when, as and if declared by the Board of Directors, out of funds of the Company legally available therefor, monthly dividends, at the rate of $1.20 per share per year, or 12.0% of the Fixed Price of $10.00 per share, which dividends will be cumulative, and payable in cash or in kind, commencing six months after the date that the Common Stock commenced trading on Nasdaq.
In the event of any liquidation of the Company or any Deemed Liquidation Event (as defined in the articles), holders of Series C Preferred Stock are entitled to an amount per share equal to the greater of (a) the stated value; or (b) such amount per share as would have been payable had all Series C Preferred Stock been converted into Common Stock immediately prior to such event, prior to any payment with respect to the Common Stock.
On April 21, 2026, the Company issued 658 shares of Common Stock to its SEC counsel in consideration for legal services provided in connection with the Company's securities filings and Nasdaq listing. The shares were valued at approximately $75,000 and the amount was recorded as professional fees. The issuance was exempt from registration pursuant to Section 4(a)(2) of the Securities Act.
On April 23, 2026, upon the Company’s listing on the Nasdaq Capital Market, the Company issued 27,273 shares of common stock to the Placement Agent representing the Advisory Shares valued at $2,359,080. The issuance was exempt from registration pursuant to Section 4(a)(2) of the Securities Act.
| (b) | Use of Proceeds |
None
| (c) | Issuer Purchases of Equity Securities |
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures (Removed and Reserved)
Not applicable.
Item 5. Other Information.
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Item 6. Exhibits
The exhibit index set forth below is incorporated by reference in response to this Item 6.
| * | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC. | ||
| By: | /s/ Kelvin Cooper | |
| Name: | Kelvin Cooper | |
| Title: | Chief Executive Officer (Principal Executive Officer) | |
| By: | /s/ Peter Ceccacci | |
| Name: | Peter Ceccacci | |
| Title: | Chief Financial Officer | |
| (Principal Financial Officer) | ||
Dated: August 13, 2026
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