Transcode Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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Sep 30, 2025 · Filed Nov 14, 2025
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NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
(1) Nature of Business and Liquidity
TransCode Therapeutics, Inc. (the “Company” or “TransCode”) was incorporated on January 11, 2016, under the laws of the State of Delaware. TransCode is a biopharmaceutical company focused primarily on developing and commercializing innovative drugs for treating cancer. TransCode is a clinical-stage company. The Company’s lead therapeutic candidate, TTX-MC138, comprises an oligonucleotide conjugated to an iron oxide nanoparticle designed to be administered by infusion to inhibit the ability of metastatic tumor cells to survive. The goal of the therapy, if approved, is to achieve durable disease regression, progression-free survival and long-term patient survival.
On October 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with DEFJ, LLC, a Delaware limited liability company, (“DEFJ”) pursuant to which the Company acquired 100% of the issued and outstanding membership interests of ABCJ, LLC, a Delaware limited liability company, (“ABCJ”) (such transaction, the “Acquisition”). Prior to the Acquisition, ABCJ was a wholly owned subsidiary of DEFJ and an indirect wholly owned subsidiary of CK Life Sciences Int’l., (Holdings) Inc., a listed entity on the Main Board of the Hong Kong Stock Exchange. See Note 16.
ABCJ owns 100% of the issued and outstanding membership interests of Polynoma, LLC, a Delaware limited liability company, (“Polynoma”) headquartered in San Diego, California. Polynoma is an immuno-oncology focused biopharmaceutical company developing seviprotimut-L, a Phase 3-ready investigational polyvalent antigen vaccine intended to reduce the risk of recurrence of melanoma in patients in stage IIB and IIC who have limited options. Seviprotimut-L has been safely administered in clinical trials in more than 1,000 patients.
The Company intends to work on developing both TTX-MC138 and seviprotimut-L, with the initial focus on advancing TTX-MC138 in a planned Phase 2a clinical trial. The Company believes there is potential to augment seviprotimut-L's focus with TTX-MC138 by addressing micrometastases in stage IIB and IIC melanoma patients.
Concurrent with the Acquisition, the Company entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ agreed to purchase, and the Company agreed to issue and sell in a private placement, an aggregate of 223.7337 shares of Series B Non-Voting Preferred Stock, par value $0.0001 per share, (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”) for a price per share of $111,740, for an aggregate purchase price of approximately $25 million. The aggregate purchase price consisted of a cash subscription amount of $20 million paid on October 8, 2025, and a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $5 million (together, the “October 2025 Investment”). The Promissory Note has a principal amount of approximately $5 million and accrues interest at a rate of 4% per annum, calculated as simple interest on a 365-day year. The principal and accrued but unpaid interest are due and payable on January 1, 2026, and secured by 44.7467 shares of the Series B Preferred Stock issued to DEFJ. Each share of Series B Preferred Stock is convertible into 10,000 shares of Common Stock.
The Company has not generated revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any early-stage biopharmaceutical company that requires substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approvals, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital.
The Company plans to expand development of its lead therapeutic candidate and other candidates, and to explore strategic partnerships. Management believes that its cash at September 30, 2025, along with the net proceeds from the October 2025 Investment, is sufficient to fund operations and capital requirements into the fourth quarter 2026.
To further support its planned operations, the Company will require additional capital; however, the Company cannot be certain that additional funding will be available on acceptable terms, or at all. Through the date of these financial statements, the Company’s primary source of capital was from the sale of equity securities in its initial public offering (“IPO”) and subsequent financings, sales of convertible promissory notes prior to the IPO, and funds received under SBIR Awards beginning in April 2021. For the foreseeable future, the Company plans to fund its operations by continuing to raise additional capital, primarily through sales of equity or debt, and from funds that may be awarded under government and other grants.
To the extent the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. Any debt financing, if available, may include potentially dilutive features and include restrictive covenants that impact the Company’s ability to conduct business. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly scale back its planned operations or (ii) relinquish or otherwise dispose of rights to technologies on unfavorable terms.
Going Concern
These financial statements have been prepared under the assumption that the Company will continue as a going concern which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. Due to the Company’s recurring and expected continuing losses from operations, the Company has concluded there is substantial doubt concerning its ability to continue as a going concern within one year of the issuance of these financial statements without additional capital becoming available. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To date, the Company has incurred substantial losses and negative cash flows from operations. It expects to continue to incur operating losses for the foreseeable future as it pursues development of its lead therapeutic candidate and other programs. Operating losses are expected to continue until such time, if ever, that the Company can generate significant revenue from product candidates currently in development. The Company is unable to predict the extent of any future losses or when the Company will become profitable, if ever.
For the nine months ended September 30, 2025, net cash used in operating activities was approximately $11.4 million and the Company’s net loss was approximately $21.2 million. As of September 30, 2025, the Company had an accumulated deficit of approximately $84.4 million and approximately $2.8 million in cash.
(2) Summary of Significant Accounting Policies
| (a) | Basis of Presentation |
|---|
The interim financial statements included herein are unaudited. These financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, these financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair presentation of the financial position of the Company at September 30, 2025, its results of operations for the three and nine months ended September 30, 2025 and 2024, and its cash flows for the nine months ended September 30, 2025 and 2024. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2024, and notes thereto contained in the Company’s Annual Report on Form 10-K, filed with the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements.
| (b) | Use of Estimates |
|---|
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant items subject to such estimates and assumptions include but are not limited to the valuation of share-based compensation, valuation of warrant liability, income from grants, and accrued research and development costs. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates.
| (c) | Basic and Diluted Loss per Share |
|---|
Basic net loss per share is determined by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share includes the effect, if any, from the potential conversion, vesting or exercise of securities (“Contingent Securities”) such as convertible promissory notes, stock options and warrants which would result in the issuance of additional shares of common stock. The computation of diluted net loss per shares does not include the conversion or exercise of Contingent Securities when the effect of doing so would be antidilutive.
| (d) | Cash |
|---|
The Company classifies deposits in banks, money market funds and cash invested temporarily in various instruments with original maturities of three months or less as cash. To date, the Company has not held any funds in money market funds or instruments with original maturities of three months or less. The Company holds significant cash balances in U.S. banks which throughout the year regularly exceed the federally insured limit of $250,000. Any loss incurred or lack of access to such funds could have a material adverse effect on the Company’s financial condition, results of operations, and cash flows.
| (e) | Fair Value of Financial Instruments |
|---|
The Company’s financial instruments as of the balance sheet dates included cash, grant receivable, prepaid expenses and other current assets, right-of-use asset, accounts payable and accrued expenses, deferred grant income, and current and long-term portion of lease liability. Cash is reported at fair value. The recorded carrying amounts of grant receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, deferred grant income, and current and long-term portion of lease liability approximate their fair value due to their short-term or fixed arrangements nature.
| (f) | Research and Development |
|---|
Research and development (“R&D”) costs generally are expensed as incurred and primarily comprise expenses to discover, research and develop therapeutic candidates. These expenses may include personnel costs, share-based compensation expense, materials and supplies, allocated facility-related and depreciation expenses, third-party license fees, and costs under arrangements with third-party vendors, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and consultants. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as expenses as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
The Company has entered into various research and development-related contracts with companies both inside and outside the United States. The related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of manufacturing and clinical studies, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates.
Patent Costs
All legal fees and expenses and costs related to patent-related filings with governmental authorities incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Other patent costs are classified as R&D expenses.
| (g) | Grant Income |
|---|
Funds from grants are recognized as grant income in the statements of operations as and when earned for the specific research and development projects for which the grants are designated. In April 2021 and September 2024, the Company received awards (the “Awards”) from the National Cancer Institute in support of the Company’s lead therapeutic candidate. Since there is no transfer of ownership of the work performed under the Awards, and the Company does not lose control over the work performed under the Awards, the Company deems the Awards funds as contributions. Grant payments received in excess of grant income earned are recorded as deferred grant income on the Company’s balance sheets until the related income has been earned. Grant income earned in excess of grant payments received is recorded as grant receivable on the Company’s balance sheets.
| (h) | Share-Based Compensation |
|---|
Share-based compensation, if any, for employees and non-employees is measured at the grant date based on the fair value of the award. The Company recognizes compensation expense, if any, for awards to employees and directors over the requisite service period, which is generally the vesting period of the respective award, and for awards to non-employees over the period during which services are rendered by such non-employees until completed. Under applicable accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies share-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Forfeitures are accounted for as they occur.
The estimated fair value of the common stock used by the Company to determine the expense of option awards is the closing Nasdaq price of the Company’s common shares on the date of each award. Other factors used in calculating the fair value of share-based awards represented management’s best estimates, some of which involve inherent uncertainties and the application of management’s judgment. As a result, if factors were to change and management were to use different assumptions, share-based compensation expense could be materially different.
Certain stock appraisal methodologies utilize, among other variables, the volatility of the stock price. When private, the Company lacked Company-specific historical and implied volatility information for its stock. Therefore, it estimated its expected stock price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time, if ever, as it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected life of options awarded was estimated using the simplified method because the Company has limited historical information on which to base reasonable expectations about future exercise patterns and post-vesting employment. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect
at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on its common stock and does not expect to pay cash dividends in the foreseeable future.
(i) Property and Equipment
Property and equipment are recorded at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows:
| | | |
|---|---|---|
| | Estimated useful life | |
| Laboratory equipment | 3 years | |
| Furniture and fixtures | 5 years | |
| Computer and office equipment | 3 years | |
| Leasehold improvements | Shorter of the useful life or remaining lease term |
When assets are retired or otherwise disposed of, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the statements of operations in the period of disposal. Expenditures for repairs and maintenance are charged to expense as incurred.
| (j) | Income Taxes |
|---|
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of the dates of the Company’s balance sheets herein, the Company had a full valuation allowance against deferred tax assets.
The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (“ASC 740”). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
There are currently no open federal or state tax audits. The Company has not recorded any liability for uncertain tax positions at the dates of the Company’s balance sheets herein.
| (k) | Emerging Growth Company Status |
|---|
The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act (“JOBS Act”) and may take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of a public offering or such earlier time that it is no longer an EGC.
(l)Reverse Stock Splits
On May 23, 2023, the Company effected a reverse split of the Company’s common stock, either issued and outstanding or held by the Company as treasury stock, (the “2023 Reverse Split”) previously approved by the Company’s Board of Directors (“Board”) and stockholders of the Company. The 2023 Reverse Split was at a ratio ofone share for every 20 shares previously held with no change in the par value per share. The 2023 Reverse Split did not change the number of authorized shares of common stock.
On January 16, 2024, the Company effected a reverse split of the Company’s common stock, either issued and outstanding or held by the Company as treasury stock, (the “January 2024 Reverse Split”) previously approved by the Board and stockholders of the Company. The January 2024 Reverse Split was at a ratio ofone share for every 40 shares previously held with no change in the par value per share. The January 2024 Reverse Split did not change the number of authorized shares of common stock.
On December 4, 2024, the Company effected a reverse split of the Company’s common stock, either issued and outstanding or held by the Company as treasury stock, (the “December 2024 Reverse Split”) previously approved by the Board and stockholders of the Company. The December 2024 Reverse Split was at a ratio ofone share for every 33 shares previously held with no change in the par value per share. The December 2024 Reverse Split did not change the number of authorized shares of common stock.
On May 15, 2025, the Company effected a reverse split of the Company’s common stock, either issued and outstanding or held by the Company as treasury stock, (the “May 2025 Reverse Split”) previously approved by the Company’s Board of Directors (“Board”) and stockholders of the Company. The May 2025 Reverse Split was at a ratio ofone share for every 28 shares previously held with no change in the par value per share. The May 2025 Reverse Split did not change the number of authorized shares of common stock.
All common stock share and per share data, and exercise price data for applicable common stock equivalents, included in these financial statements have been retroactively adjusted to reflect the foregoing reverse stock splits.
(m)Collaboration Agreements
When the Company enters into a collaboration agreement, it evaluates the arrangement against the requirements of ASC 808, “Collaborative Arrangements,” as well as ASU 2018-18 which clarifies the interaction between Topic 808 and Topic 606. ASU 2018-18 indicates that collaborative arrangements could be partially in the scope of other guidance, including ASC 606.
(n)Leases
From time to time, the Company leases certain office and laboratory space. At inception, the Company determines if a contract or arrangement contains a lease. Leases are evaluated and classified as either operating or finance leases. A lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. A lease that does not meet any of the criteria to be classified as a finance lease is classified as an operating lease. Operating leases are included on the balance sheets as right-of-use (“ROU”) assets, net; current portion of operating lease liabilities; and operating lease liabilities. ROU assets and operating lease liabilities are recognized based on the present value of the future lease payments over the lease term at the commencement date. Where leases do not provide an implicit rate for
use in determining the present value of future payments, the Company uses an incremental borrowing rate that represents the cost of borrowing on a collateralized basis for a period equal to the expected lease term. ROU assets also include any lease payments made and exclude any lease incentives and initial direct costs incurred. Lease terms may include periods under options to extend the lease or terminate the lease prior to expiration when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term, including rent abatement periods and rent holidays. While lease liabilities are not remeasured as a result of changes to these costs, changes are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred. Finance leases are included on the balance sheets as property and equipment, net; current maturities of long-term debt; and long-term debt. Finance lease costs are split between depreciation expense related to the asset and interest expense on the lease liability, using the effective rate charged by the lessor. The Company has elected to account for lease and non-lease components separately. Additionally, the Company has elected not to record short-term leases, those with expected terms of twelve months or less, on the balance sheets. Certain lease agreements include fixed escalations, while others include rental payments adjusted periodically for inflation.
(o)Warrant Accounting
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, “Distinguishing Liabilities from Equity” (“ASC 480”), and ASC 815, “Derivatives and Hedging” (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares and whether warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end-date while the warrants are outstanding.
For issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component of equity at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as liabilities at their initial fair value on the date of issuance, and their fair value at each balance sheet date thereafter. Changes in the estimated fair value of warrants classified as liabilities are recognized as a non-cash gain or loss on the statements of operations.
Warrants the Company issued upon financings in January and July 2024 and in March 2025 met the criteria for equity classification under ASC 815 and were classified as equity. Warrants the Company issued upon a financing that closed December 2, 2024, did not meet the criteria for equity classification under ASC 815 and were classified as liabilities.
(p)Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB and are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued accounting pronouncements will not have a material impact on the Company’s financial position, results of operations, and cash flows, or do not apply to its operations.
In December 2023, the FASB issued ASU No. 2023-09, “Improvements to Income Tax Disclosures”, (“ASU 2023-09”) which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU 2023-09 is effective for the Company’s Annual Report on Form 10-K for the year ending December 31, 2025. Early adoption is permitted. The
Company is currently evaluating the impact of this ASU on its income tax disclosures within its financial statements and expects changes to its income tax disclosure.
In November 2024, the FASB issued ASU No. 2024-03, “Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures: Disaggregation of Income Statement Expenses” (“ASU 2024-03”). ASU 2024-03 will require more detailed information about the types of expenses in commonly presented income statement captions such as “Cost of sales” and “Selling, general and administrative expenses”. The new guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that this change will have on the Company’s disclosures.
**(3)**Fair Value Measurements
ASC 820, “Fair Value Measurements”, provides guidance on the development and disclosure of fair value measurements. The Company follows this guidance for fair value measurements, which defines fair value, establishes a framework for measuring fair value under U.S. GAAP, and expands disclosures about fair value measurements. The guidance requires that fair value measurements be classified and disclosed in one of the following three categories:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities.
Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
Level 3: Unobservable inputs which are supported by little or no market activity with values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of the dates of the Company’s balance sheets herein. The carrying amount of cash, grant receivable, prepaid expenses and other current assets, right-of-use asset, accounts payable and accrued expenses, deferred grant income, and current and long-term portion of lease liability approximated their fair value due to their short-term or fixed arrangements nature. Warrant liabilities were recorded based on their assessed fair value.
The Company records warrant liability for warrants issued in the December 2, 2024, financing transaction at assessed fair value, a Level 3 measurement on the fair value hierarchy due to the significant unobservable inputs used in their valuation such as probability-weighted outcomes regarding shareholder approval and potential de-listing of the Company stock. The fair value of the warrant liability at December 31, 2024, was determined using a Monte Carlo simulation model within a risk-neutral framework. This widely accepted financial modeling approach is employed to value complex instruments, including warrants with strike price reset and anti-dilution provisions. The model simulates multiple potential future paths for the Company’s stock price, accounting for the reset provision by adjusting the strike price if the stock price falls below a specified level, but not lower than the specified Floor Price. Upon each reset of the strike price, the quantity of warrants was also adjusted based on the warrants’ anti-dilution provisions. For each simulated path, the warrant’s payoff is calculated using the final stock price and the potentially adjusted strike price and quantity, then discounted to present value. The fair value is estimated as the average of these discounted payoffs across all simulated paths. This method ensures the valuation reflects the impact of the strike price reset provision and anti-dilution provision on the warrants’ potential values.
The table below lists key assumptions used in the valuations of the warrant liability as of September 30, 2025, and December 31, 2024. The $833 thousand fair value of the Series C Warrants as of September 30, 2025, was an increase of $315 thousand from December 31, 2024, which increase was recorded as change in fair value of warrant liability. Fair value as of September 30, 2025, was determined using a Black-Scholes valuation model which the Company deemed appropriate as both the exercise price of the warrants and the number of shares issuable were known, no longer requiring use of a simulation model, such as the Monte Carlo valuation model, used to determine fair value at December 31, 2024.
| | | | | |
|---|---|---|---|---|
| Assumptions | | September 30, 2025 | | December 31, 2024 |
| Risk-free rate | | 3.68% | | 4.33% |
| Volatility | | 115.00% | | 150.00% |
| Expiration date of Series C | | February 24, 2030 | | November 29, 2029 |
| Expiration date of Series D | | N/A | | May 29, 2027 |
| Shareholder approval date | | N/A | | February 25, 2025 |
| Potential de-listing date | | N/A | | N/A |
The fair value of the warrant liability is as follows:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · Warrants · · Warrants · · Total Warrant | |||||||||
| Level 3 Rollforward: · · Series C · · Series D · · Liability | |||||||||
| Balance, December 31, 2023 | | $— | | $— | | $— | |||
| Additions | | | 501,961 | | | 5,100,746 | | | 5,602,707 |
| Change in fair value | | | 15,910 | | | 922,780 | | | 938,690 |
| Balance, December 31, 2024 | | | 517,871 | | | 6,023,526 | | | 6,541,397 |
| Additions | | | — | | | — | | | — |
| Change in fair value | | | 315,004 | | | 9,360,793 | | | 9,675,797 |
| Exercise of Series D warrants | | | — | | | (15,384,319) | | | (15,384,319) |
| Balance, September 30, 2025 | | $832,875 | | $— | | $832,875 | |||
**(4)**Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · 2025 · 2024 | ||||||
| Prepaid operating expenses | | $18,149 | | $31,563 | ||
| Contract manufacturers and research organizations | | 882,137 | | 517,484 | ||
| Insurance premiums | | 458,051 | | 310,735 | ||
| Prepaid FICA | | | 358,499 | | | 422,492 |
| | | $1,716,836 | | $1,282,274 | ||
**(5)**Property and Equipment
Property and equipment, net, consisted of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, · December 31, | ||||
| | | 2025 | | 2024 |
| Laboratory and computer equipment | | $362,387 | | $362,387 |
| Less accumulated depreciation | | (342,479) | | (310,813) |
| Total property and equipment, net | | $19,908 | | $51,574 |
Depreciation expense for the three months ended September 30, 2025 and 2024, was $4,781 and $16,031, respectively, and $31,666 and $80,548, respectively, for the nine months ended September 30, 2025 and 2024.
**(6)**Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Professional and general consulting fees | | $735,248 | | $1,282,428 | ||
| R&D-related – CMOs, CROs, supplies, equipment and consulting | | 1,735,281 | | 1,148,917 | ||
| General expenses | | 60,493 | | 143,988 | ||
| Insurance premiums | | 145,036 | | 765 | ||
| Payroll and benefits | | | 216,770 | | | 131,342 |
| Accrued license payments | | | 75,000 | | | 697 |
| | | $2,967,828 | | $2,708,137 | ||
At September 30, 2025, and December 31, 2024, the Company’s outstanding payables to CROs or CMOs included above were $1,153,186 and $997,074, respectively.
See Note 8 for further information regarding accrued license payments.
**(7)**Grant Income
In September 2024, the Company received its second Award (the “2024 Award”) from the National Cancer Institute of the National Institutes of Health (the “NIH”). The 2024 Award is a Direct to Phase II SBIR Award to support IND-enabling and clinical trial activities in the Company’s clinical trial with its lead candidate, TTX-MC138, overtwo years. The total 2024 Award is for $1,999,972 of which $1,011,207 applies to the first year and $988,765 applies to the second year.
The Company recognized grant income of $22,174 and $11,953 for the three months ended September 30, 2025 and 2024, respectively, and $523,704 and $39,010, respectively, for the nine months ended September 30, 2025 and 2024. The Company had deferred grant income of $0 at September 30, 2025, and $25,408 at December 31, 2024. The Company had grant receivable of$198,296 at September 30, 2025, and $0 at December 31, 2024.
| (8) | Commitments and Contingencies |
(a)Operating Lease
In December 2022, the Company signed an agreement to sublease 4,837 square feet of laboratory and office space in Newton, Massachusetts, from another biopharmaceutical company. The Company considered this sublease an
operating lease with estimated right-of-use assets and lease liabilities of $874,957 recorded upon lease commencement on February 1, 2023. The sublease had an initial term of 24 months, and the Company had the option to extend the sublease for an additional 12 months but didnot elect to exercise the option. Because the Company did not believe that the exercise of this option was probable, it did not include it in determination of the lease amounts. The base monthly rent was $37,285 during the first 12 months of the lease and $38,403 in the second 12 months. In addition, the Company was responsible for its share of operating expenses, real estate taxes, and utilities based on the actual costs of these items. Upon termination of this lease on January 31, 2025, the Company relocated its business operations to another location under a six-month agreement for $3,520 per month with options to renew semi-annually.
Rent expense for the three months ended September 30, 2025 and 2024, was $11,295 and $111,190, respectively, and $68,573 and $289,153, respectively, for the nine months ended September 30, 2025 and 2024.
(b)License Agreements
In November 2018, the Company licensed the exclusive rights to certain intellectual property to support development of its therapeutic candidates (“License”). The intellectual property licensed by the Company is owned by The General Hospital Corporation, d/b/a Massachusetts General Hospital, (“Licensor”). Payments by the Company under the license agreement included a one-time non-refundable fee of $50,000 paid after execution of the License; reimbursement of Licensor’s patent costs which, at execution of the License, were approximately $145,000; a minimum annual license fee of $25,000 payable within 60 days of each anniversary of the effective date of the License prior to the first commercial sale of a product or process covered by the License; milestone payments upon attainment of certain milestone events; royalties based on net sales of products covered by the patent-related rights; and a portion of any sublicense income received by the Company. The Company is responsible for the development and commercialization of the licensed assets and for meeting certain milestones set forth in the License.
Royalties to be paid to Licensor shall be assessed on net sales of licensed products on a country-by-country basis in an amount equal to 3.0% for therapeutic products or processes, and 6.0% for clinical diagnostic products and processes. The Company shall pay Licensor 30% of any and all sublicense income.
In November 2020, the Company and Licensor amended the November 2018 license. Under the amendment, the intellectual property licensed in 2018 was categorized as “Patent Family 1” and a provisional patent filing related to the Company’s nanoparticle technology was added to Patent Family 1. A second patent family (“Patent Family 2”) was created which includes Licensor intellectual property targeting PD-L1. The minimum annual license fee prior to the first commercial sale of a product or process covered by the License was increased from$25,000 per year to $30,000 per year for Patent Family 1 and a minimum annual license fee of $10,000 per year was added related to Patent Family 2. All other terms of the License including milestone payments, royalties and payment terms related to sublicense income received by the Company remain the same as in the original License.
Effective August 15, 2025, the Company and Licensor further amended the License (the “Second Amendment”) to revise the diligence requirements and milestone payments. In connection with the Second Amendment, Company paid Licensor a license amendment fee of $75,000. The Second Amendment revised certain one-time milestone payments to be made by Company to Licensor, for Products and Processes covered by each Patent Family as follows The Second Amendment revised certain one-time milestone payments to be made by us to Licensor for Products and Processes covered by the License as follows:
(i) a certain dollar amount within sixty (60) days following dosing of first patient in the first phase II clinical trial for a Therapeutic Product or Therapeutic Process for each Patent Family;
(ii) a certain dollar amount within sixty (60) days following dosing of first patient in the first phase III clinical trial for a Therapeutic Product or Therapeutic Process for each Patent Family; and
(iii) a certain dollar amount within sixty (60) days following the First Commercial Sale for a Therapeutic Product or Therapeutic Process for each Patent Family.
In addition, upon the occurrence of a Change of Control Liquidity Event (as defined in the Second Amendment), the Company shall pay Licensor up to a certain dollar amount.
The Company has the right to terminate the License at any time by giving 90 days’ advance notice subject to the payment of any amounts due under the License at that time. The License may also be terminated for cause by either party upon the breach of the material obligations of the other party or the bankruptcy or liquidation of the other party. If the Company does not terminate the License, the term of the License shall continue until the latest of (i) the date on which all issued patents and filed patent applications subject to the License have expired or been abandoned; (ii) expiration of the last to expire regulatory exclusivity covering a covered product or process; or (iii)10 years after the first commercial sale. The License requires the Company to make royalty payments beyond the term of the License at 1.5%.
The milestone payments the Company shall pay to Licensor shall not exceed $2,950,000 based upon and subject to the attainment of each milestone event. These payments are generally due within 60 days of achievement of the milestone.
As of September 30, 2025, and December 31, 2024, no milestone events had been achieved.
Accrued License Obligations
At September 30, 2025, and December 31, 2024, the Company had accrued $75,000 and $697, respectively, in license payments under the foregoing arrangements included in accounts payable and accrued expenses.
| (c) | Collaboration Agreement |
|---|
On July 29, 2022, the Company signed afive-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center (“MD Anderson”). Under the collaboration, the Company anticipated making certain expenditures with respect to Phase I and Phase II clinical trials which it expected would be conducted in part through MD Anderson as a clinical trial site. MD Anderson was also to provide preclinical work under the collaboration. The details of clinical and preclinical work were to be mutually agreed by the parties prior to commencing work. The Company committed to fund up to $10 million over the term of the collaboration. Of this amount, the initial payment schedule called for $500,000 to be paid within the first year. Subsequent payments were scheduled to be $2 million on the first anniversary of the effective date of the agreement and $2.5 million on each of the second, third andfourth anniversaries thereof. In late 2024, the Company and MD Anderson agreed to amend the collaboration agreement in favor of MD Anderson focusing solely on participation in the Company’s Phase 1/II clinical trial. This amendment relieves the Company from the obligation to make up to$10 million of collaboration payments.
The Company is obligated to pay clinical trial charges incurred by MD Anderson in connection with clinical trial work conducted by MD Anderson. The$250,000 first payment made by the Company to MD Anderson in January 2023 was recorded as a Prepaid Expense pending such time as payments under the collaboration became due. As work under the collaboration is performed by MD Anderson, the Company records research and development costs in its statements of operations. Initial expenses of the clinical trial have been charged against the initial payment made to MD Anderson. For the nine months ended September 30, 2025 and 2024, these charges were $146,372 and $0, respectively.
| (d) | Employment Agreements |
|---|
Prior to the IPO, the Company entered into employment agreements with its executive officers which became effective on completion of the IPO. The employment agreements provide the employee with, among other things, severance payments upon termination of the agreement by the Company for any reason other than for cause, death or disability or by the employee for good reason. At September 30, 2025, the maximum aggregate severance payments under the agreement then in effect, which arise in the event of termination involving a Change of Control (as defined in the agreement), was approximately$1,296,000. On October 6, 2025, Philippe Calais was appointed as Chief Executive Officer and the Company entered into an employment agreement with Dr. Calais, effective October 8, 2025. See Note 16.
| (e) | Litigation |
|---|
The Company may from time to time be subject to claims by others under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition, and cash flows. At the balance sheet dates herein, the Company did not know of any claims or actions pending against it or threatened, the ultimate disposition of which could have a material adverse effect on its results of operations or financial condition except claims by an investment bank that it is entitled to fees, claims which the Company rigorously disputes.
| (f) | Indemnification Agreements |
|---|
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its Board and executive officers that require the Company, among other things, to indemnify the parties against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any costs as a result of payments required by such indemnifications. The Company is not aware of any claims for indemnification that could have a material adverse effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its financial statements as of the balance sheet dates herein.
| (g) | Risks and Uncertainties |
|---|
As geopolitical events such as wars in the Ukraine and the Middle East and major health issues such as SARS-CoV-2, or the coronavirus, continue to evolve, the extent to which they affect the Company’s operations directly or through parties on whom the Company depends is highly uncertain and cannot be predicted with confidence. The outcomes resulting from these events could delay the Company’s plans, increase its operating expenses and have a material adverse effect on its financial position, results of operations or cash flows.
| (9) | Stockholders’ Equity (Deficit) |
| (a) | Overview |
|---|
The Company’s Certificate of Incorporation, originally filed on January 11, 2016, was amended on April 15, 2020, to increase the number of shares of common stock authorized and to authorize the issuance of preferred stock. The Company’s Certificate of Incorporation was further amended and restated on April 27, 2021, on May 22, 2023, to effect the May 2023 Reverse Split, on January 16, 2024, to effect the January 2024 Reverse Split, on December 4, 2024, to
effect the December 2024 Reverse Split, and on May 5, 2025, to effect the May 2025 Reverse Split. The total number of shares which the Company is authorized to issue is 300,000,000, each with a par value of $0.0001 per share. Of these shares,290,000,000 shall be common stock and 10,000,000 shall be preferred stock. At September 30, 2025, and December 31, 2024, the Company had 833,683 and 36,753 shares of common stock issued andoutstanding, respectively. The preferred stock is undesignated; no shares of preferred stock have been issued through September 30, 2025.
On January 22, 2024, the Company closed an offering under a Securities Purchase Agreement with purchasers named therein pursuant to which the Company sold approximately 465 shares of common stock, approximately 5,968 pre-funded warrants (“PFWs”), and approximately 12,864 warrants to purchase common stock (the “January 2024 Warrants”), in a registered direct offering at a purchase price of $1,127.28 per share (or $1,118.04 per PFW) (the “January 2024 RDO”). The January 2024 Warrants became exercisable commencing on issuance and are exercisable forthree and one-half years from the date of issuance at an exercise price of $1,127.28 per share. Net proceeds from the January 2024 RDO, after deducting fees payable to the placement agent and other offering expenses, were approximately $6.1 million. The PFWs sold in the January 2024 RDO were exercisable at an exercise price of $9.24 per share. All PFWs sold in the January 2024 RDO were exercised prior to April 30, 2024. In connection with the January 2024 RDO, the Company also issued the placement agent warrants to purchase up to approximately 386 shares of common stock (the “January 2024 Placement Agent Warrants”). The January 2024 Placement Agent Warrants became exercisable on issuance, expire three and one-half years following the date of sale and have an exercise price per share of $1,409.10. See Note 10.
On July 22, 2024, the Company entered into a Placement Agency Agreement with ThinkEquity LLC pursuant to which the Company issued and sold approximately 10,823 shares of common stock in a best efforts public offering at a purchase price of $277.20 per share (the “July 2024 Offering”). Net proceeds from the July 2024 Offering, after deducting discounts, commissions and fees paid to the placement agent and other offering expenses, were approximately $2.4 million. In connection with the July 2024 Offering, the Company also issued warrants to the placement agent to purchase up to approximately 542 shares of common stock (the “July Placement Agent Warrants”). The July Placement Agent Warrants become exercisable January 18, 2025, expire July 22, 2029, and have an exercise price of $346.50 per share. See Note 10.
On December 2, 2024, the Company closed an offering under a Securities Purchase Agreement with purchasers named therein pursuant to which the Company sold 6,180 shares of common stock,16,786 PFWs, together with 22,966 Series C Warrants to purchase common stock (the “Series C Warrants”), and 22,966 Series D Warrants to purchase common stock (the “Series D Warrants”) in a private offering at a purchase price of $348.35 per share (or $348.25 per PFW) (the “2024 PIPE”). The Series C and Series D Warrants became exercisable commencing on shareholder approval which occurred February 25, 2025. The Series C Warrants are exercisable forfive years from shareholder approval; the Series D Warrants are exercisable fortwo and one-half years from such approval. The initial exercise prices for the Series C and Series D Warrants was $1,127.28 per share, subject to adjustments and resets. In addition, the Series D Warrants included an alternative cashless exchange provision whereby the holder could exchange each Series D Warrant forthree shares of Common Stock. Net proceeds from the 2024 PIPE, after deducting fees payable to the placement agent and other offering expenses, were approximately $7.2 million. The PFWs sold in the 2024 PIPE were exercisable at an exercise price of $0.0924 per share. All PFWs sold in the 2024 PIPE were exercised prior to March 31, 2025. See Note 10. The Company accounts for the Series C and D Warrants in accordance with the guidance contained in ASC 815-40. Such guidance provides that because the Series C and D Warrants do not meet the criteria for equity treatment thereunder, they must be recorded as a liability.
On March 23, 2025, the Company entered into a Placement Agency Agreement with ThinkEquity LLC pursuant to which the Company issued and sold 366,072 shares of common stock and warrants (the “March 2025 Offering Warrants”) to purchase 366,072 shares of common stock at an exercise price of $24.08 per share in a best efforts public offering at a purchase price of $27.44 per share and accompanying warrant (the “March 2025 Offering”). Net proceeds from the March 2025 Offering, after deducting discounts, commissions and fees paid to the placement agent and other
offering expenses, were approximately $8.9 million. In connection with the March 2025 Offering, the Company also issued warrants to the placement agent to purchase up to 18,304 shares of common stock (the “March 2025 Placement Agent Warrants”). The March 2025 Placement Agent Warrants became exercisable on issuance, expire March 24, 2030, and have an exercise price of $29.96 per share. See Note 10.
**(b)**Common Stock
| i. | Dividends |
Subject to the rights of holders of any preferred stock, holders of common stock are entitled to receive dividends as may be declared from time to time by the Board. The Company has never declared nor paid cash dividends through the date of these financial statements.
| ii. | Liquidation |
Subject to the rights of holders of any preferred stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the remaining assets of the Company will be distributed to holders of common stock.
| iii. | Voting |
Holders of common stock are entitled toone vote for each share of common stock held but shall not be entitled to vote on any amendment to the Certificate of Incorporation that relates solely to the terms of any series of preferred stock. There is no cumulative voting.
**(10)**Warrants
Except as noted otherwise, all the warrants described below were outstanding as of September 30, 2025, and are accounted for as a component of stockholders’ equity. All PFWs issued in the Company’s financings described herein were exercised on or before January 10, 2025.
In connection with the IPO, the Company granted the underwriter warrants (the “IPO Underwriter Warrants”) to purchase up to approximately 20 shares of Company common stock at an exercise price of $3,696,000.00 per share. The IPO Underwriter Warrants have afive-year term and were not exercisable prior to January 9, 2022.
In connection with the February 16, 2023 registered direct offering, the Company issued the February Placement Agent Warrants to purchase up to approximately four shares of common stock. The February Placement Agent Warrants became exercisable commencing August 17, 2023, expire February 16, 2028, and have an exercise price per share of $486,948.00 per share.
In connection with an agreement the Company entered into with a consultant in February 2023, the Company agreed to issue warrants (the “Consultant Warrants”) to purchase up to approximatelyone share of common stock at $369,600.00 per share. The Consultant Warrants became exercisable any time after August 23, 2023, until February 23, 2028.
In connection with the June 6, 2023 registered direct offering (the “June RDO”), the Company issued approximately 55 Series A-1 Warrants and approximately 55 Series A-2 Warrants, which became exercisable commencing June 9, 2023. The Series A-1 and Series A-2 Warrants expire three years following the date of sale and have anexercise price of $348.35 per share. The Company also issued warrants to the June RDO placement agent to purchase up to approximately 4 shares of common stock. The June RDO Placement Agent Warrants became exercisable commencing June 9, 2023, expire three years after issuance, and have an exercise price per share of $161,700.00 per share.
In connection with the September Offering, the Company issued warrants to the underwriter to purchase up to approximately 23 shares of common stock. Approximately 16 additional warrants were issued to the underwriter in October 2023 in connection with the underwriter’s partial exercise of the overallotment option. The September Offering Underwriter Warrants became exercisable commencing 180 days after issuance, expire five years following the date of sale and have an exercise price per share of $23,562.
In connection with the December 4, 2023 registered direct offering, the Company issued the December Placement Agent Warrants to purchase up to approximately nine shares of common stock. The December Placement Agent Warrants became exercisable on issuance, expire five years following the date of issuance, and have an exercise price per share of $11,180.40.
In connection with the January 2024 RDO, the Company issued the January 2024 Warrants to purchase up to approximately 12,864 Warrants to purchase common stock at a purchase price of $1,127.28 per share. The January 2024 Warrants became exercisable commencing on issuance and are exercisable forthree and one-half years from the date of issuance generally at an exercise price of $1,127.28 per share. All PFWs sold in the January 2024 RDO were exercised prior to April 30, 2024. In connection with the January 2024 RDO, the Company also issued the placement agent the January 2024 Placement Agent Warrants to purchase up to approximately 386 shares of common stock. The January 2024 Placement Agent Warrants became exercisable on issuance, expire three and one-half years following the date of sale and have an exercise price per share of $1,409.10.
In connection with the July 2024 Offering, the Company issued to the placement agent the July Placement Agent Warrants to purchase up to approximately 542 shares of common stock. The July Placement Agent Warrants became exercisable January 18, 2025, expire July 22, 2029, and have an exercise price of $346.50 per share.
In connection with the 2024 PIPE, the Company issued approximately 144,678 Series C Warrants and 144,678 Series D Warrants. The Series C and Series D Warrants became exercisable commencing on shareholder approval which occurred February 25, 2025. The Series C Warrants are exercisable forfive years from shareholder approval; the Series D Warrants were exercisable fortwo and one-half years from such approval. The initial exercise price for the Series C and Series D Warrants was $69.67 per share, subject to adjustments and resets. In addition, the Series D Warrants included an alternative cashless exchange provision whereby the holder could exchange each Series D Warrant forthree shares of Common Stock. The Series C Warrants and the Series D Warrants are accounted for as liabilities. All Series D warrants were exchanged for common stock in the first quarter 2025.
In connection with the March 2025 Offering, the Company issued the March 2025 Offering Warrants to purchase up to 366,072 shares of common stock at an exercise price of $24.08 per share. The March 2025 Offering Warrants became exercisable commencing on issuance and are exercisable forfive years from the date of issuance. In connection with the March 2025 Offering, the Company also issued the placement agent the March 2025 Placement Agent Warrants to purchase up to 18,304 shares of common stock. The March 2025 Placement Agent Warrants became exercisable on issuance, expire five years following the date of sale and have an exercise price of $29.96 per share.
The following table summarizes the Company’s outstanding warrants at September 30, 2025:
| · · · · · | ||||
|---|---|---|---|---|
| · Number · Exercise Price | ||||
| Description | | of Shares | | Per Share |
| IPO Underwriter Warrants | 20 | | $3,696,000 | |
| February 2023 Placement Agent Warrants | 4 | | | 486,948 |
| February 2023 Consultant Warrants | 1 | | | 369,600 |
| June 2023 Series A-1 warrants | 55 | | | 348.35 |
| June 2023 Series A-2 warrants | 55 | | | 348.35 |
| June 2023 Placement Agent Warrants | 4 | | | 161,700.00 |
| September 2023 Underwriter Warrants | 23 | | | 23,562.00 |
| October 2023 Underwriter Overallotment Warrants | 16 | | | 23,562.00 |
| December 2023 Placement Agent Warrants | 9 | | | 11,180.40 |
| January 2024 Warrants | 6,745 | | | 1,127.28 |
| January 2024 Warrants | 5,422 | | | 438.90 |
| January 2024 Placement Agent Warrants | 386 | | | 1,409.10 |
| July 2024 Placement Agent Warrants | 542 | | | 346.50 |
| December 2024 Series C Warrants | 144,678 | | | 69.67 |
| March 2025 Offering Warrants | 366,072 | | | 24.08 |
| March 2025 Placement Agent Warrants | 18,304 | | | 29.96 |
Approximately 697 of the January 2024 Warrants were exercised in the first half of 2024. In December 2024, the Company modified the exercise price applicable to the Series A-1 and Series A-2 Warrants to $348.35, and certain January 2024 Warrants to $438.90 per share. In connection with the modification, the Company recorded a deemed dividend in the aggregate of $30,601. During the first quarter 2025, all Series D warrants were exchanged for common stock representing 425,895 shares after reset adjustments.
(11) Share-Based Compensation
In April 2020, the Board approved the TransCode Therapeutics, Inc. 2020 Stock Option and Incentive Plan (the “2020 Plan”) providing for the issuance of options or other awards to purchase up to approximately five shares of the Company’s common stock. Following the closing of the IPO, the Board determined not to make any further awards under the 2020 Plan. In March 2021, the Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) was approved by the Company’s Board and stockholders and became effective upon the effectiveness of the IPO. The 2021 Plan initially provided for the issuance of options or other awards to purchase up to approximately seven shares of the Company’s common stock. The number of options or other awards available under the 2021 Plan increased approximatelyone share in January 2022, approximatelyone shares in January 2023, approximately 34 shares in January 2024, approximately 3,247 shares in June 2024, and approximately 1,838 shares in January 2025.
Both Plans provide for grants of equity in the form of stock awards, stock options and other instruments to employees, members of the Board, officers and consultants of and advisors to the Company. The Plans are administered by the Board or, at the discretion of the Board, by a committee of the Board. The amount and terms of grants are determined by the Board. The terms of options granted under the Plans generally are for ten (10) years after date of grant and are exercisable in cash or as otherwise determined by the Board. The vesting period for equity-based awards is determined at the discretion of the Board and is generallytwo tofour years. If stock options granted under the 2021 Plan terminate, expire, or are surrendered or cancelled, the shares subject to such grants will again be available under the 2021 Plan.
The exercise price for incentive stock options is determined at the discretion of the Board but for grants to any person possessing less than 10% of the total combined voting power of all classes of stock may not have an exercise price less than 100% of the fair market value of the Common Stock on the grant date (110% for grants to any person
possessing more than 10% of the total combined voting power of all classes of stock). The option term for incentive stock option awards may not be greater than ten years from the date of the grant (five years for grants to any person possessing more than 10% of the total combined voting power of all classes of stock).
Of options outstanding at September 30, 2025, approximately 10 were awarded under the 2020 Plan and approximately 2,025 were awarded under the 2021 Plan.
At September 30, 2025, there were approximately 8 options outstanding under the 2020 Plan that were vested and exercisable and approximately 1,891 options outstanding under the 2021 Plan that were vested and exercisable. Information about options to purchase common stock of the Company under both Plans is as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · Weighted · | |||||
| · · · · average · · Weighted | |||||
| · · · · exercise · · average | |||||
| · · Number of · · price · · contractual | |||||
| · · shares · · per share · · term (years) | |||||
| Outstanding at December 31, 2023 | 85 | $387,691.92 | 3.7 | ||
| Granted | 2,100 | | | 1,108.80 | 9.2 |
| Exercised | — | | | — | — |
| Forfeited | (83) | | | 13,365.75 | — |
| Outstanding at December 31, 2024 | 2,102 | | | 2,206.40 | 9.4 |
| Granted | — | | | — | — |
| Exercised | — | | | — | — |
| Forfeited | (67) | | 106,636.80 | — | |
| Outstanding at September 30, 2025 | 2,035 | | $15,642.82 | 8.6 | |
The intrinsic value of the outstanding options as of September 30, 2025, was $0.
Option Valuation
No options were granted in the nine months ended September 30, 2025. The assumptions that the Company used to determine the grant-date fair value of options granted in the year ended December 31, 2024, were as follows:
| | | |
|---|---|---|
| | | Year Ended |
| | | December 31, 2024 |
| Risk-free interest rate | 4.44% | |
| Expected term (in years) | 6.0 | |
| Expected volatility | | 128.8% |
| Expected dividend yield | — | |
| Fair value per share of underlying stock | | $29.68 - $30.24 |
The weighted average grant date fair value per share of the options granted in the year ended December 31, 2024, was $1,108.77.
The Company recorded share-based compensation expense of $134,324 and $423,563 during the three and nine months ended September 30, 2025, respectively, and $204,482 and $1,531,229 during the three and nine months ended September 30, 2024, respectively, all of which related to stock options. The remaining share-based compensation expense to be recognized in the future is $149,291 over approximately 0.5 years.
(12)** **Employee Stock Purchase Plan
In 2021, the Company adopted an Employee Stock Purchase Plan (the “ESPP”) to provide eligible employees of the Company with opportunities to purchase shares of the Company’s common stock. The ESPP initially provided for the purchase of an aggregate of up to approximatelysix shares of common stock. The number of shares of common stock available through the ESPP increased by approximately three shares in each of January 2022 through January 2025 and may be increased each subsequent year by up to approximately three shares.
(13) Net Loss per Share
The Company reported net losses for the three and nine months ended September 30, 2025 and 2024. Reported basic and diluted net loss per share attributable to common stockholders are the same for each period because shares issuable in connection with Contingent Securities have been excluded from the computation of diluted weighted-average shares outstanding. The effect of their inclusion would have been antidilutive. In accordance with ASC 260-10-45-13, a pre-funded, or penny, warrant is an instrument that requires the holder to pay little or no consideration to receive the shares upon exercise of the warrant. Since the shares underlying the PFWs are issuable for little or no consideration, the Company considered them outstanding in the context of basic earnings per share.
The following table sets forth the computation of basic and diluted loss per share:
| · · · · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · Nine months ended September 30, | |||||||||
| · 2025 · 2024 · 2025 · 2024 | |||||||||
| Basic and diluted net loss per share · · · · · · · · · · · · · | |||||||||
| Net loss attributable to common stockholders | | $(4,856,051) | | $(2,321,387) | | $(21,217,966) | | $(10,839,013) | |
| Weighted-average common shares outstanding | | 833,683 | | 15,893 | | 615,264 | | 9,696 | |
| Net loss per share | | $(5.82) | | $(146.06) | | $(34.49) | | $(1,117.89) | |
(14) Income Taxes
The Company’s income tax benefit (expense) was $0 for the nine months ended September 30, 2025 and 2024. The Company has recorded a full valuation allowance against its net deferred tax assets at September 30, 2025, and December 31, 2024, because the Company has determined that it is more likely than not that these assets will not be fully realized due to historic net operating losses incurred. Accordingly, the benefit of the net operating loss that would have been recognized in the three and nine months ended September 30, 2025 and 2024, was fully offset by changes in the valuation allowance.
At September 30, 2025, and December 31, 2024, the Company hadno accrued interest or penalties related to uncertain tax positions andno amounts have been recognized in the Company’s statements of operations.
(15) Segment Reporting
ASC 280, “Segment Reporting” establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organization structure as well as information about services categories, business segments and major customers in financial statements. The Company has a single reportable business unit segment, RNA drug development, andone reportable country segment, the United States of America, for the three and nine months ended September 30, 2025 and 2024.
The Company adheres to the provisions of ASC 280, “Segment Reporting,” which establishes standards for the way public business enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in financial statements issued to shareholders. In
accordance with ASC 280, the Company’s chief operating decision maker (the “CODM”) has been identified as its Interim Chief Executive Officer and Chief Financial Officer. The Company’s CODM reviews the financial information presented for purposes of allocating resources and evaluating its financial performance for the entire Company. Accordingly, the Company has determined that it operates in a single reportable segment. All of the Company’s long-lived assets are located in the United States. Since the Company operates inone operating segment, all required financial segment information can be found in the financial statements.
The Company does not distinguish between markets or segments for the purpose of internal reporting. The majority of the Company’s long-lived assets are located in Michigan, US, and its deferred tax assets are US-related.
Existing guidance, which is based on a management approach to segment reporting, establishes requirements to report selected segment information quarterly and to report annually entity-wide disclosures about products and services, major customers, and the countries in which the entity holds material assets and reports revenue. All material operating units qualify for aggregation under “Segment Reporting” due to their similar activities and similarities in economic characteristics; and similarities in procurement, manufacturing and distribution processes.
(16) Subsequent Events
For its financial statements as of September 30, 2025, the Company evaluated subsequent events through November 14, 2025, the date on which those financial statements were issued and determined that there were none for which recognition or disclosure is warranted other than as set forth below.
Membership Interest Purchase Agreement and Investment Agreement
On October 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with DEFJ, LLC, a Delaware limited liability company (“DEFJ”), pursuant to which the Company acquired 100% of the issued and outstanding membership interests of ABCJ, LLC, a Delaware limited liability company (“ABCJ”) (such transaction, the “Acquisition”). Prior to the Acquisition, ABCJ was a wholly owned subsidiary of DEFJ and an indirect wholly owned subsidiary of CK Life Sciences Int’l., (Holdings) Inc., a listed entity on the Main Board of the Hong Kong Stock Exchange.
Under the terms of the Purchase Agreement, upon the consummation of the Acquisition, which occurred concurrently with the execution of the Purchase Agreement (the “Closing”), in exchange for all of the membership interests of ABCJ outstanding immediately prior to the Closing, the Company issued to DEFJ an aggregate of (i)83,285 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), which shares represented 9.99% of the shares of Common Stock outstanding immediately prior to the Closing, and (ii)1,152.9568 shares of the Company’s Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (“Series A Preferred Stock”) (as described below). In addition, the Company has agreed to make up to$95,000,000 in contingent milestone payments to DEFJ upon the achievement of certain milestones. Each share of Series A Preferred Stock is convertible into 10,000 shares of Common Stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation (as defined and described below). The Acquisition is intended to be treated as a taxable exchange for U.S. federal income tax purposes.
Concurrently with the Acquisition, on October 8, 2025, the Company entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ agreed to purchase, and the Company agreed to issue and sell in a private placement, an aggregate of 223.7337 shares of Series B Non-Voting Preferred Stock, par value $0.0001 per share (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”), for a price per share of $111,740, for an aggregate purchase price of approximately $25 million, consisting of a cash subscription amount of approximately $20 million and a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $5 million (together, the “October 2025 Investment”). The Promissory Note accrues
interest at a rate of 4% per annum, calculated as simple interest on a 365-day year. The principal and accrued but unpaid interest are due and payable on January 1, 2026, and secured by 44.7467 shares of the Series B Preferred Stock issued to DEFJ. Each share of Series B Preferred Stock is convertible into 10,000 shares of Common Stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series B Preferred Stock are set forth in the Certificate of Designation. The closing of the October 2025 Investment occurred on October 8, 2025.
The Board of Directors of the Company (the “Board”) unanimously approved the Purchase Agreement, the Investment Agreement and the related transactions, and the consummation of the Acquisition and the October 2025 Investment was not subject to approval by the Company’s stockholders. Pursuant to the Purchase Agreement, the Company has agreed to hold a stockholders’ meeting to submit the following matters to its stockholders for their consideration: (i) the approval of the conversion of the shares of Series A Preferred Stock into shares of Common Stock in accordance with the rules of the Nasdaq Stock Market LLC (the “Conversion Proposal”) and (ii) the approval of a “change of control” under Nasdaq Listing Rules 5110 and 5635(b) (the “Change of Control Proposal” and, together with the Conversion Proposal, the “Meeting Proposals”). In connection with these matters, the Company has agreed to file a proxy statement on Schedule 14A with the U.S. Securities and Exchange Commission, or SEC, within 30 days following receipt by the Company of all of the financial statements required to be delivered pursuant to Section 4.14 and Section 4.2(e) of the Purchase Agreement.
Pro Forma Stockholders’ Equity
The following financial information has been developed by applying pro forma adjustments to the historical financial statements of the Company appearing elsewhere in this Quarterly Report on Form 10-Q. This unaudited pro forma information gives effect to the October 2025 Investment.
The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the October 2025 Investment actually occurred on the dates indicated, nor does the unaudited pro forma financial information purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q.
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · September 30, 2025 | |||||||||
| · · (Unaudited) | |||||||||
| · · As · · · · As Adjusted | |||||||||
| · Reported · Adjustments (A) · Pro Forma | |||||||||
| Assets · · | |||||||||
| Current assets: | | | | | | | | | |
| Cash | | $2,835,916 | | $18,247,409 | | $21,083,325 | |||
| Grant receivable | | | 198,296 | | | — | | | 198,296 |
| Prepaid expenses and other current assets | | | 1,716,836 | | | — | | | 1,716,836 |
| Total current assets | | | 4,751,048 | | | 18,247,409 | | | 22,998,457 |
| Property and equipment, net of depreciation | | | 19,908 | | | — | | | 19,908 |
| Deferred offering costs | | | 455,726 | | | — | | | 455,726 |
| Total assets | | $5,226,682 | | $18,247,409 | | $23,474,091 | |||
| | | | | | | | | | |
| Liabilities and Stockholders’ Equity (Deficit) | | | | | | | | | |
| Current liabilities: | | | | | | | | | |
| Accounts payable and accrued expenses | | $2,967,828 | | $— | | $2,967,828 | |||
| Total current liabilities | | | 2,967,828 | | | — | | | 2,967,828 |
| Long-term liabilities: | | | | | | | | | |
| Warrant liability - Series C | | | 832,875 | | | — | | | 832,875 |
| Long-term liabilities | | | 832,875 | | | — | | | 832,875 |
| Total liabilities | | | 3,800,703 | | | — | | | 3,800,703 |
| Stockholders’ equity (deficit): | | | | | | | | | |
| Preferred stock – $0.0001 par value; 10,000,000 shares authorized at September 30, 2025, and December 31, 2024; -0- shares issued or outstanding at September 30, 2025, and December 31, 2024 | | | — | | | — | | | — |
| Common stock – $0.0001 par value, 290,000,000 shares authorized at September 30, 2025, and December 31, 2024; 833,683 and 36,753 shares issued and outstanding at September 30, 2025, and December 31, 2024, respectively | | | 84 | | | — | | | 84 |
| Additional paid-in capital | | | 85,845,777 | | | 18,247,409 | | | 104,093,186 |
| Accumulated deficit | | | (84,419,882) | | | — | | | (84,419,882) |
| Total stockholders’ equity (deficit) | | | 1,425,979 | | | 18,247,409 | | | 19,673,388 |
| Total liabilities and stockholders’ equity (deficit) | | $5,226,682 | | $18,247,409 | | $23,474,091 | |||
Note
| (A) | Gross proceeds from the October 2025 Investment less offering expenses. |
Contingent Value Rights Agreement
Effective as of October 8, 2025, the Company entered into a Contingent Value Rights Agreement (the “CVR Agreement”) with Vstock Transfer, LLC as rights agent (the “Rights Agent”), pursuant to which each holder of Common Stock as of as of 5:00 p.m. Eastern Time on October 20, 2025, including those holders receiving shares of Common Stock in connection with the Acquisition, is entitled toone contractual contingent value right (each, a “CVR”) issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Common Stock held by such holder as of such time. The CVR Agreement has a term ofseven years.
When issued, each CVR will entitle the holders thereof (the “Holders”), in the aggregate, to 50% of the Net Proceeds (as defined in the CVR Agreement) from any Upfront Payment (as defined in the CVR Agreement) or Milestone Payment (as defined in the CVR Agreement) received by the Company in a given calendar quarter.
The distributions in respect of the CVRs that become payable will be made on a quarterly basis and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to certain taxes and certain out-of-pocket expenses incurred by the Company.
Under the CVR Agreement, the Rights Agent has, and Holders of at least 40% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than as permitted pursuant to the CVR Agreement.
Registration Rights Agreement
On October 8, 2025, in connection with the Acquisition and Investment, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with DEFJ. Pursuant to the Registration Rights Agreement, the Company is required to prepare and file a resale registration statement with the SEC within 75 calendar days following the closing of the Acquisition and the October 2025 Investment with respect to the shares of Common Stock and the Common Stock underlying the Preferred Stock issued to DEFJ pursuant to the Acquisition and the October 2025 Investment, as well as the Common Stock underlying the up to 28.4291 shares of Series A Preferred Stock issuable to DEFJ as a one-time payment-in-kind dividend as set forth in the Certificate of Designation. The Company will use its commercially reasonable efforts to cause such registration statement to be declared effective by the SEC as soon as practicable. In addition, the Company granted certain demand and piggyback registration rights to DEFJ.
The Company has also agreed, among other things, to indemnify DEFJ and its partners, members, directors, officers, stockholders, legal counsel, accountants and underwriters and each Person who controls any such holder or underwriter (within the meaning of Section 15 of the Securities Act of 1933, as amended (the “Securities Act”), or Section 20 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)).
Repurchase Agreement
On October 8, 2025, in connection with the Acquisition, the Company entered into a Repurchase Agreement (the “Repurchase Agreement”) with DEFJ. The Repurchase Agreement provides that DEFJ has the right, but not an obligation, upon the occurrence of certain events after the Closing, to exercise an option to acquire all of the Company’s and its subsidiaries’ rights in and to the membership interests of ABCJ from the Company, in accordance with the terms and conditions of the Repurchase Agreement.
Transaction Costs
In connection with the Acquisition and the October 2025 Investment (together, the “Transactions”), the Company incurred legal fees and other transaction costs, excluding financial advisory fees, of approximately $1,000,000.
Tungsten Advisors (through its broker-dealer, Finalis Securities LLC) (“Tungsten”) acted as financial advisor to the Company in connection with the Acquisition and as placement agent for the Company in connection with the October 2025 Investment. Following the closings of the Transactions, as partial compensation for services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 59.2255 shares of Series A Preferred Stock and paid cash of $1,800,000. All of the compensation to Tungsten was contingent on the closing of the Transactions.
Additional transaction costs or general and administrative expenses related to the Transactions are expected to be incurred as the Company seeks to satisfy its obligations under the Transactions and related agreements.
Certificate of Designation
On October 8, 2025, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Preferred Stock and Series B Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the Acquisition and the October 2025 Investment. The Certificate of Designation provides for the designation of shares of the Preferred Stock.
Holders of Preferred Stock are entitled to receive dividends on shares of Preferred Stock (on an as-if-converted-to-Common-Stock basis, without regard to the Beneficial Ownership Limitation (as defined in the Certificate of Designation), equal to and in the same form, and in the same manner, as dividends (other than dividends on shares of Common Stock payable in the form of Common Stock) actually paid on shares of Common Stock when, as and if such dividends (other than dividends payable in the form of Common Stock) are paid on the shares of Common Stock; provided, however, that in no event are holders of Preferred Stock entitled to receive the “rights” distributed pursuant to the CVR Agreement, or any amounts paid under the CVR Agreement. In addition, holders of Series A Preferred Stock shall be entitled to receive, and the Company shall pay, payment-in-kind dividends on each share of Series A Preferred Stock, accruing at a rate equal to 5% per annum payable in shares of Series A Preferred Stock on the date that is the earlier of 180 days after the date of the original issuance of such Series A Preferred Stock or the date of stockholder approval of the Meeting Proposals.
Except as otherwise required by law, the Preferred Stock does not have voting rights. However, as long as any shares of Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or Bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of Preferred Stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of, the Preferred Stock, regardless of whether any of the foregoing actions are by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Preferred Stock, or increase or decrease (other than by conversion) the number of authorized shares of Preferred Stock, (iii) prior to the Stockholder Approval (as defined in the Certificate of Designation) or at any time while at least 30% of the originally issued Preferred Stock remains issued and outstanding, consummate either: (A) any Fundamental Transaction (as defined in the Certificate of Designation) or (B) any merger or consolidation of the Company with or into another entity or any stock sale to, or other business combination in which the stockholders of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after such transaction, or (iv) enter into any agreement with respect to any of the foregoing.
The Preferred Stock shall rank on parity with the Common Stock as to distributions of assets upon liquidation, dissolution or winding-up of the Company, whether voluntarily or involuntarily.
Each share of Series A Preferred Stock then outstanding shall be convertible, at any time and from time to time following the earlier to occur of: (i) 5:00 p.m. Eastern Time on the third Business Day after the date that the Stockholder Approval is obtained and (ii) the delisting of the Common Stock from Nasdaq. Each share of Series B Preferred Stock then outstanding shall be convertible, at any time and from time to time following the earliest to occur of: (i) April 8, 2026, (ii) the effectiveness date of a registration statement covering the resale of the Common Stock issuable upon conversion of the Series B Preferred Stock, (iii) 5:00 p.m. Eastern Time on the third business day after the Stockholder Approval is obtained, and (iv) the delisting of the Common Stock from Nasdaq, in each case at the option of the holder thereof, into a number of shares of Common Stock based upon the applicable conversion ratio, subject in all cases to any applicable Beneficial Ownership Limitation (as defined in the Certificate of Designation). Notwithstanding the foregoing, prior to receipt by the Company of the Stockholder Approval, the Company shall not be required to effect any conversion to the extent that such conversion would cause the Company to violate the listing rules of the Nasdaq Stock Market.
The Company shall not effect any conversion of any share of Preferred Stock, to the extent that, after giving effect to such attempted conversion, such stockholder would beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation, which shall initially be set at 9.99% for each holder. Holders may adjust or waive the Beneficial Ownership Limitation upon written notice to the Company upon the earlier of (i) the receipt of the Stockholder Approval and (ii) the consummation of a Fundamental Transaction.
The foregoing description of the Preferred Stock and the Certificate of Designation does not purport to be complete and is qualified in its entirety by reference to the full text of the Certificate of Designation.
On October 27, 2025, upon obtaining the consent of a majority of the holders of the Series A Preferred Stock and Series B Preferred Stock, and the approval of the Company’s Board of Directors, the Company filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series A Preferred Stock and Series B Preferred Stock (the “Amended and Restated Certificate of Designation”) with the Secretary of State of the State of Delaware.
The Amended and Restated Certificate of Designation amended Section 6.1.1 of the Certificate of Designation to clarify that for as long as the Purchase Agreement remains in effect and for as long as any shares of Preferred Stock remain outstanding, prior to receipt by the Company of the Stockholder Approval of the conversion of the applicable series of Preferred Stock into shares of the Company’s Common Stock, in accordance with the listing rules of the Nasdaq Stock Market, as set forth in the Purchase Agreement, the Company shall not issue pursuant to the Purchase Agreement and Section 6.1.1 of the Amended and Restated Certificate of Designation more than an aggregate of 19.9% of the Common Stock outstanding as of October 8, 2025. In addition, the Amended and Restated Certificate of Designation removed the ability of a holder of Preferred Stock to convert, at the option of such holder, the Preferred Stock into Common Stock in the event of a delisting of the Common Stock from Nasdaq.
The filing of the Amended and Restated Certificate of Designation was intended to amend and restate the terms mentioned above, and no additional securities were issued or sold as a result.
Director Appointment
On October 6, 2025, upon the recommendation of the Nominating and Corporate Governance Committee, the Board elected Elizabeth Czerepak to the Board, effective October 8, 2025. Ms. Czerepak will serve with a term expiring at the Company’s annual meeting of stockholders to be held in 2026, at which time she is expected to stand for election by the Company’s stockholders, or until her earlier death, resignation or removal. The Board determined that Ms. Czerepak is an independent director as that term is defined by the SEC and the Nasdaq Stock Market, LLC (“Nasdaq”).
Since April 2024, Ms. Czerepak has served as the Chief Financial Officer at Mirror Biologics, Inc., a private, clinical-stage company focused on cell-based oncology therapies, where she also served as Acting Chief Executive Officer between July 2024 and May 2025. Since February 2020, Ms. Czerepak has also served as a member of the board of directors of Delcath Systems Inc., a public, interventional oncology company focused on the treatment of primary and metastatic liver cancers. From May 2022 to November 2023, she served as the Chief Financial Officer at Sorrento Therapeutics, Inc., a clinical stage biopharmaceutical company focused on developing oncology, non-opioid pain, and Covid therapies, where she served as a member of the board of directors from October 2021 to May 2022. In February 2023, Sorrento announced it commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code and in November 2023 entered into a court-approved asset sale. From May 2022 to September 2023, Ms. Czerepak also served as Chief Financial Officer at Scilex Holding Company, a commercial pharmaceutical company focused on developing and commercializing non-opioid pain therapies. She continued to serve as consultant to Scilex until September 2024. Prior to that, from September 2020 to May 2022, she served as Chief Financial Officer at BeyondSpring Inc., a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies. She received a B.A. magna cum laude in Spanish and Mathematics Education from Marshall University and an M.B.A. from Rutgers University. She is a registered
securities representative (series 7 and 8) and received a corporate director certificate from the Harvard Business School Executive Education in 2020.
As a non-employee director, Ms. Czerepak will receive cash and equity compensation for her Board service pursuant to its non-employee director compensation policy. There are no arrangements or understandings between Ms. Czerepak and any other person pursuant to which Ms. Czerepak was selected as a director, and there are no transactions between Ms. Czerepak and the Company that would require disclosure under Item 404(a) of Regulation S-K. In addition, the Company has entered into an indemnification agreement with Ms. Czerepak in connection with her appointment to the Board which is in substantially the same form as that entered into with the existing directors of the Company.
Board Committees
Effective October 8, 2025, the Board accepted Philippe Calais’s resignation as chairperson of the Company’s Audit Committee and as a member of the Company’s Compensation Committee. The Board then appointed Ms. Czerepak to serve as a member and chairperson of the Audit Committee, until her successor is duly elected and qualified, or until her earlier death, resignation or removal, or until otherwise determined by the Board.
CEO Appointment; One-Time Bonuses
Effective October 8, 2025, the Board accepted Thomas A. Fitzgerald’s resignation as Interim Chief Executive Officer of the Company and appointed Dr. Calais as Chief Executive Officer. Mr. Fitzgerald will continue serving as Chief Financial Officer of the Company and Director. In connection with the change to his role, the Board approved an adjusted annual base salary of $440,000 for Mr. Fitzgerald, and Mr. Fitzgerald will be eligible for an annual cash incentive bonus target of 35% of his base salary. The Board also approved a one-time transaction bonus payment of $250,000 to each of Dr. Calais and Mr. Fitzgerald, effective as of the Closing.
In connection with Dr. Calais’s new role, the Company entered into an Employment Agreement (the “Calais Employment Agreement”) with Dr. Calais, effective October 8, 2025, (the “Effective Date”). The Calais Employment Agreement provides for an annual base salary of $555,000, and Dr. Calais will be eligible for an annual cash incentive bonus target of at least 50% of his base salary. In addition, subject to Board approval, Dr. Calais will receive a stock option to purchase a number of shares of Common Stock equal to 4% of the Company’s capitalization on a fully diluted basis, to be granted as soon as reasonably practicable after the Effective Date. The term of such option will be 10 years, and subject to any vesting acceleration rights Dr. Calais may have, the option will vest as to 25% of the total shares subject to the option on the 12-month anniversary of the Effective Date, and as to 1/48th of the total shares subject to the option on the corresponding day of each month thereafter (and if there is no corresponding day, the last day of the month), so that the option will be fully vested and exercisable four years from the Effective Date, subject to Dr. Calais’s continued services to the Company through each vesting date.
Pursuant to the Calais Employment Agreement, in the event that Dr. Calais’s employment is terminated by the Company without “cause” or he resigns for “good reason,” as each such term is defined in the Calais Employment Agreement, subject to his execution and non-revocation of a separation agreement, including a general release of claims, Dr. Calais shall be entitled to receive (i) semi-monthly continuing payments of severance pay at a rate equal to his base salary, as then in effect, for 12 months following the date of his termination and (ii) a pro-rated annual bonus for the fiscal year in which Dr. Calais terminates employment equal to (x) the annual bonus that Dr. Calais would have received based on actual performance for such fiscal year if Dr. Calais had remained in the employ of the Company for the entire fiscal year multiplied by (y) a fraction, the numerator of which is the number of days Dr. Calais was in the employ of the Company during the fiscal year including the date of termination and the denominator of which is 365, multiplied by (z)1.0, which, if any, shall be paid at the same time annual bonuses are paid by the Company to other executives of the Company for the fiscal year in which Dr. Calais terminated employment, but no later than March 15th of the calendar year following the calendar year in which Dr. Calais terminated employment. In addition, if Dr. Calais’s employment is terminated by the Company without cause or he resigns for good reason, the Company shall reimburse the premiums for
his health, medical and dental insurance, including those incurred under COBRA, until the earlier of (A)12 months following the date of termination, (B) the date upon which Dr. Calais and/or his eligible dependents become covered under similar plans, or (C) the date upon which Dr. Calais is (or his eligible dependents are) no longer eligible for COBRA coverage.
In lieu of the severance payments and benefits set forth above, if Dr. Calais’s employment is terminated by the Company without cause or Dr. Calais resigns for good reason and such termination or resignation occurs withinsix months prior to or 24 months following a “change in control,” as defined in the Calais Employment Agreement, absent the Company obtaining an agreement from any successor to assume the Calais Employment Agreement (which assumption shall be subject to Dr. Calais’s consent) and subject to his execution of a separation agreement, including a general release of claims, Dr. Calais shall be entitled to:
· a lump sum payment equal to the sum of 18 months of Dr. Calais’s base salary plus a pro-rated annual bonus for the fiscal year in which Dr. Calais terminates employment equal to (x) the annual bonus that Dr. Calais would have received based on the greater of actual or target performance for such fiscal year if Dr. Calais had remained in the employ of the Company for the entire fiscal year multiplied by (y) a fraction, the numerator of which is the number of days Dr. Calais was in the employ of the Company during the fiscal year including the date of termination and the denominator of which is 365, multiplied by (z)1.5, which shall be paid at the same time annual bonuses are paid by the Company to other executives of the Company for the fiscal year in which Dr. Calais terminated employment, but no later than March 15th of the calendar year following the calendar year in which Dr. Calais terminated employment;
· vesting in full of any unvested and outstanding equity awards as of the date of termination; and
· reimbursement by the Company for any expenses incurred by Dr. Calais for his health, medical and dental insurance under COBRA, until the earlier of (i)18 months following the date of termination, (ii) the date upon which Dr. Calais and/or his eligible dependents become covered under similar plans, or (iii) the date upon which Dr. Calais is (or his eligible dependents are) no longer eligible for COBRA coverage.
The foregoing description of the Calais Employment Agreement is only a summary and is qualified in its entirety by the Calais Employment Agreement, a copy of which is filed as an exhibit to this Quarterly Report on Form 10-Q.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.