Transcode Therapeutics, Inc.
For the period ended Dec 31, 2024. Filed Apr 15, 2025.
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FY2024 · Filed Apr 15, 2025
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Notes to Financial Statements
(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 and diagnostics for treating and identifying cancer. TransCode recently commenced its first clinical trial. 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 and long-term patient survival.
From its founding until mid-2021, the Company was engaged in organizational activities, including raising capital, and limited research and development (“R&D”) activities. On July 13, 2021, the Company completed the initial public offering (“IPO”) of its common stock, raising approximately $28.8 million in gross proceeds. The net proceeds from the IPO were approximately $25.4 million after deducting underwriting discounts, commissions and estimated offering expenses payable by the Company, including offering costs paid in 2020. Since the IPO, the Company has increased its R&D activities, hired additional employees, and begun more traditional operations. Following the IPO, the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol “RNAZ.” Upon the closing of the IPO, outstanding convertible promissory notes converted into approximately 1,335 shares of Company 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 December 31, 2024, together with the net proceeds of approximately $8.8 million from an equity financing completed March 25, 2025, is sufficient to fund operations and capital requirements into the fourth quarter 2025, but does not believe that existing cash will be sufficient to fund requirements for a full 12 months from the date of issuance of these financial statements.
To 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 December 31, 2024, the Company’s primary source of capital was from the sale of equity securities in the IPO and subsequent financings, previous sales of convertible promissory notes 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.
(1) Nature of Business and Liquidity (continued)
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 year ended December 31, 2024, net cash used in operating activities was approximately $13.3 million and the Company’s net loss was approximately$16.8 million. As of December 31, 2024, the Company had an accumulated deficit of approximately $63.2 million and approximately $5.8 million in cash.
(2) Summary of Significant Accounting Policies
(a) Basis of Presentation
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”).
(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 at December 31, 2024 and 2023, 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 the 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) Recent Accounting Pronouncement
In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. The ASU 2023-07 is effective for annual reporting periods beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company’s adoption of ASU 2023-07 on January 1, 2024, did not have a material impact on the Company’s financial statements.
(m) 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.
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 thethree reverse stock splits.
(n) 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.
(o) Leases
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.
(p) 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 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 we issued upon our financings in January and July 2024 met the criteria for equity classification under ASC 815 and were classified as equity. Warrants we issued upon our financing that closed December 2, 2024 did not meet the criteria for equity classification under ASC 815 and were classified as liabilities. Warrants issued upon our financings in 2023 met the criteria for equity classification under ASC 815 and were classified as equity.
(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 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 are recorded based on their fair value.
The Company records it warrant liability at fair value and is considered a Level 3 measurement on the fair value hierarchy due to the significant unobservable imputs used in their valuation such as the probability weighted outcomes regarding the shareholder approval date and the potential de-listing date. The fair value of the warrant liability 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 warrants are also adjusted for quantity, based on the 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 following key assumptions were used in the valuation of the warrant liability as of the issuance date of November 26, 2024, and as of December 31, 2024:
| | | |
|---|---|---|
| Assumptions | November 26, 2024 | December 31, 2024 |
| Risk-free rate | 4.53% | 4.33% |
| Volatility | 165.00% | 150.00% |
| Expiration date of Series C | November 29, 2029 | November 29, 2029 |
| Expiration date of Series D | May 29, 2027 | May 29, 2027 |
| Shareholder approval date | February 25, 2025 | February 25, 2025 |
| Potential de-listing date | June 30, 2025 | June 30, 2025 |
The fair value of the warrant liability is as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Level 1 · · Level 2 · · Level 3 · · Total | ||||||||||||
| Warrant liabilities | | | | | | | | | | | | |
| PIPE warrants - Series C | | $— | | | — | | $517,871 | | $517,871 | |||
| PIPE warrants - Series D | | | — | | | — | | | 6,023,526 | | | 6,023,526 |
| Total warrant liabilities, at fair value | | $— | | $— | | $6,541,397 | | $6,541,397 | ||||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · PIPE Warrants · · PIPE Warrants · · Total Warrant | |||||||||
| Level 3 Rollforward: · · Series C · · Series D · · Liability | |||||||||
| Balance, December 31, 2022 | | $— | | $— | | $— | |||
| Additions | | | — | | | — | | | — |
| Change in fair Value | | | — | | | — | | | — |
| 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 | |||
(4) Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · 2024 · 2023 | ||||||
| Prepaid operating expenses | | $31,563 | | $116,607 | ||
| Contract manufacturers and research organizations | | 517,484 | | 717,686 | ||
| Insurance premiums | | 310,735 | | 431,061 | ||
| Prepaid FICA | | | 422,492 | | | 422,492 |
| | | $1,282,274 | | $1,687,846 | ||
(5) Property and Equipment
Property and equipment, net consisted of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, · December 31, | ||||
| | | 2024 | | 2023 |
| Laboratory and computer equipment | | $362,387 | | $384,050 |
| Less accumulated depreciation | | (310,813) | | (263,343) |
| Total property and equipment, net | | $51,574 | | $120,707 |
Depreciation expense for the years ended December 31, 2024 and 2023 was $90,894 and $123,483, respectively.
(6) Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · December 31, | ||||||
| · · 2024 · · 2023 | ||||||
| Professional and general consulting fees | | $1,282,428 | | $375,550 | ||
| R&D-related – CMOs, CROs, supplies, equipment and consulting | | 1,148,917 | | 1,260,578 | ||
| General expenses | | 143,988 | | 295,508 | ||
| Insurance premiums | | 765 | | 400,236 | ||
| Payroll and benefits | | | 131,342 | | | 589,404 |
| Accrued license payments | | | 697 | | | 129,983 |
| | | $2,708,137 | | $3,051,259 | ||
(6) Accounts Payable and Accrued Expenses (continued)
At December 31, 2024 and 2023, the Company’s outstanding payables to CROs or CMOs included above were $997,074 and $1,020,875, respectively.
See Note 8 for further information regarding the accrued license payments.
(7) Grant Income
In April 2021, the Company received a Fast-Track Small Business Innovation Research, or SBIR, Award from the National Cancer Institute of the National Institutes of Health (the “NIH”). The Award was for up to $2,392,845 over three years to fund a two-phased research partnership between the Company and Massachusetts General Hospital. In May 2021, the Company received first-year funding of $308,861. In May 2022, second-year funding of $1,129,316 was made available to the Company. In April 2023, the Company received funding of $870,684 for the third year of the SBIR Award. Income under the grant is recognized as work under the grant is completed. The Company recognized grant income of $524,064 and $923,035 for the years ended December 31, 2024 and 2023, respectively. The Company recorded grant income receivable of $0 at December 31, 2024, and 2023. The Company had deferred grant income of $25,408 and $27,057 at December 31, 2024 and 2023, respectively.
(8) Commitments and Contingencies
(a) Leases
In March 2021, the Company entered into an agreement with Massachusetts Biomedical Initiatives, Inc. (“MBI”) whereby the Company has subleased approximately 2,484 square feet of laboratory space with room for minor administrative functions. The Company was also permitted to use shared laboratory equipment at the facility. The monthly rental was $6,521, and the Company paid an additional amount for its allocated share of operating expenses, which in 2022 was $3,105 per month. In 2022, the Company added the right to use cubicle space outside its laboratory area to its sublease for an additional $650 per month, resulting in total monthly rental of $10,276. The sublease terminated as of February 2023.
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 considers 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.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating lease for the year ended December 31, 2024. Prior to February 1, 2023, the Company had no operating leases with maturities greater than one year. The Company does not recognize any variable lease costs or short-term lease costs in connection with the operating lease.
| · · · | ||
|---|---|---|
| · Year Ended | ||
| Operating Leases | | December 31, 2024 |
| Weighted average remaining lease term (years) | 0.1 | |
| Weighted average discount rate | 3.6% | |
| | | | |
|---|---|---|---|
| Year ending December 31, · · | |||
| 2025 | | $38,291 | |
| Total undiscounted lease payments | | | 38,291 |
| Imputed interest | | | — |
| Lease liability | | $38,291 | |
Rent expense for the years ended December 31, 2024 and 2023 was $411,662 and $575,192, respectively.
(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.
The milestone payments the Company shall pay to Licensor shall not exceed $1,550,000 based upon and subject to the attainment of each milestone event indicated below. These payments are generally due within 60 days of achievement of the milestone.
| · · · | ||
|---|---|---|
| Milestone Event | Amount | |
| Enrollment of first patient in a phase II clinical trial of a therapeutic product or process | | $100,000 |
| Enrollment of first patient in a phase III clinical trial of a therapeutic product or process | | $200,000 |
| First commercial sale of a therapeutic product or process | | $1,000,000 |
| Filing of an application for regulatory approval of a clinical diagnostic product or process | | $100,000 |
| First regulatory approval of a clinical diagnostic product or process | | $150,000 |
As of December 31, 2024 and 2023, no milestone events had been achieved.
The 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.
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%.
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.
Accrued License Obligations
At December 31, 2024 and 2023, the Company had accrued $697 and $129,983, 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 expects will be conducted in part through MD Anderson as a primary investigator site. MD Anderson was also 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. Payments to MD Anderson are initially recorded as Prepaid Expenses. As work under the collaboration is performed by MD Anderson, the Company will record research and development costs in its statements of operations. 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 become due. In late 2024, we and MD Anderson agreed to amend the collaboration agreement in favor of MD Anderson focusing solely on participation in our Phase 1/II clinical trial. This amendment relieves us from the obligation to make up to $10 million of collaboration payments. We are obligated to pay charges incurred by MD Anderson in connection with the clinical trial. Initial expenses of the clinical trial will be charged against the initial payment made to MD Anderson. For the years ended December 31, 2024 and 2023, these charges were $279,768 and $0, respectively.
(d) Employment Agreements and Severance
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. The maximum aggregate severance payments under the agreements, which arise in the event of termination involving a Change of Control (as defined in the agreements), are approximately $1,296,000.
In December 2023, the Board approved various actions designed to streamline the Company’s operations and reduce expenses (the “Restructuring”). These included delaying or eliminating certain development activities and reducing headcount by laying offfour employees. This lowered the Company’s headcount toeight employees at December 31, 2024, compared to 11 at December 31, 2023. Severance in the aggregate of $424,576 was provided to the affected employees and charged to expense.
(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 December 31, 2024 and 2023, 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 these 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 indemnification arrangements 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 December 31, 2024 and 2023.
(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, continues to evolve, the extent to which it affects 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 condition or results of operations.
(9) Stockholders’ Equity
(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, and on December 4, 2024, to effect the December 2024 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 December 31, 2024 and 2023, the Company had 1,029,095 and 19,014 shares of common stock issued and outstanding, respectively. The preferred stock is undesignated; no shares of preferred stock have been issued.
On February 16, 2023, the Company entered into a Securities Purchase Agreement with purchasers named therein pursuant to which the Company sold approximately 108 shares of common stock in a registered direct offering at a purchase price of $13,912.80 per share (the “February RDO”). Net proceeds from the February RDO, after deducting fees payable to the placement agent and other offering expenses, were approximately $1.2 million. In connection with the February RDO, the Company also issued the placement agent warrants to purchase up to approximately 8 shares of common stock (the “February Placement Agent Warrants”). The February Placement Agent Warrants became exercisable commencingsix months following the date of issuance, expire five years following the date of sale and have an exercise price per share of $17,391.00 (see Note 10).
In April and May 2023, the Company sold an aggregate of approximately 83 shares to White Lion Capital LLC (“White Lion”) under a Common Stock Purchase Agreement dated April 14, 2023, (the “White Lion Purchase Agreement”) between the Company and White Lion. Net proceeds to the Company were $518,844 after reimbursement of White Lion expenses but before $75,418 of legal and printing expenses the Company incurred. The commitment period under the White Lion Purchase Agreement ended May 31, 2023.
(9) Stockholders’ Equity (continued)
On June 6, 2023, the Company entered into a Securities Purchase Agreement with a purchaser named therein pursuant to which the Company sold approximately 75 shares of common stock, approximately 1,440 pre-funded warrants (“PFWs”), together with accompanying 1,516 Series A-1 Warrants to purchase common stock (the “Series A-1 Warrants”), and 1,516 Series A-2 Warrants to purchase common stock (the “Series A-2 Warrants”) in a registered direct offering at a purchase price of $4,620.00 per share (or $4,606.80 per PFW) (the “June RDO”). The Series A-1 Warrants and the Series A-2 Warrants are identical in all material respects. The Series A-1 Warrants and Series A-2 Warrants became exercisable commencing June 9, 2023, and are exercisable forthree years at an exercise price of $4,290.00 per share. Net proceeds from the June RDO, after deducting fees payable to the placement agent and other offering expenses, were approximately $6.1 million. The PFWs sold in the June RDO were exercisable at an exercise price of $0.33 per share. All the PFWs sold in the June RDO were exercised prior to September 30, 2023.
In connection with the June RDO, the Company also issued the placement agent warrants to purchase up to approximately 107 shares of common stock (the “June Placement Agent Warrants”). The June Placement Agent Warrants became exercisable commencing June 9, 2023, expire three years following the date of sale and have an exercise price per share of $5,775.00 (see Note 10).
On September 26, 2023, the Company entered into an underwriting agreement pursuant to which it issued and sold approximately 530 shares of common stock and approximately 12,245 PFWs, including the partial exercise of the underwriter’s overallotment option, in a public offering at a purchase price of $673.20 per share (or $660.00 per PFW) (the “September Offering”). The overallotment option provided the underwriter with the right to purchase up to approximately 1,772 shares or PFWs during the 45 days following the September Offering. The terms of the sale of shares or PFWs in the September Offering also applied to purchases made by the underwriter through exercises of the overallotment option. At September 30, 2023, approximately 5,369 September Offering PFWs had been exercised. On October 4, 2023, the underwriter exercised the overallotment option to purchase approximately 253 shares of common stock. Net proceeds from the September Offering, after deducting underwriting discounts, commissions and fees paid to the underwriter and other offering expenses, were approximately $7.0 million.
In connection with the September Offering, the Company also issued warrants to the underwriter to purchase up to approximately 651 shares of common stock (the “September Underwriter Warrants”). The September Underwriter Warrants become exercisable commencing 180 days after issuance, expire five years following the date of sale and have an exercise price of $841.50 per share (see Note 10).
On December 4, 2023, the Company entered into a Securities Purchase Agreement with two purchasers named therein pursuant to which the Company sold approximately 3,788 shares of common stock in a registered direct offering at a purchase price of $319.44 per share (the “December RDO”). Net proceeds from the December RDO, after deducting fees payable to the placement agent and other offering expenses, were approximately $0.9 million. In connection with the December RDO, the Company also issued warrants to the placement agent to purchase up to approximately 228 shares of common stock (the “December Placement Agent Warrants”). The December Placement Agent Warrants became exercisable on issuance, expire five years following the date of sale and have an exercise price per share of $399.30 (see Note 10).
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 12,998 shares of common stock, approximately 167,082 pre-funded warrants (“PFWs”), together with approximately 360,159 Warrants to purchase common stock (the “January 2024 Warrants”), in a registered direct offering at a purchase price of $40.26 per share (or $39.93 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 $40.26 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 $0.33 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 10,805 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 $50.325. See Note 10.
(9) Stockholders’ Equity (continued)
On July 22, 2024, the Company entered into a Placement Agency Agreement with ThinkEquity LLC pursuant to which the Company issued and sold approximately 303,030 shares of common stock in a best efforts public offering at a purchase price of $9.90 per share (the “July 2024 Offering”). Net proceeds from the July 2024 Offering, after deducting discounts, commissions and fees paid to the placement agents 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 15,152 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 $12.375 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 173,033 shares of common stock,470,007 pre-funded warrants (“PFWs”), together with 643,039 Series C Warrants to purchase common stock (the “Series C Warrants”), and 643,039 Series D Warrants to purchase common stock (the “Series D Warrants”) in a private offering at a purchase price of $12.4409 per share (or $12.4376 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 price for the Series C and Series D Warrants was $15.675 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 $0.0033 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.
(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. No cash dividends were declared or paid during the year ended December 31, 2024, nor at any other time 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 December 31, 2024, and are accounted for as a component of stockholders’ equity. All PFWs issued in the Company’s financings 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 12 shares of Company common stock at an exercise price of $132,000.00 per share. The IPO Underwriter Warrants have afive-year term and were not exercisable prior to January 9, 2022.
(10) Warrants (continued)
In connection with the February RDO, the Company issued the February Placement Agent Warrants to purchase up to approximately 8 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$17,391.00 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 5 shares of common stock at $13,200.00 per share. The Consultant Warrants became exercisable any time after August 23, 2023, until February 23, 2028.
In connection with the June RDO, the Company issued approximately 1,516 Series A-1 Warrants and approximately 1,516 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 an exercise price of $4,290.00 per share. The Company also issued warrants to the June RDO placement agent to purchase up to approximately 107 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 $5,775.00 per share.
In connection with the September Offering, the Company issued warrants to the underwriter to purchase up to approximately 652 shares of common stock. The September Offering Underwriter Warrants become exercisable commencing 180 days after issuance, expire five years following the date of sale and have an exercise price per share of $841.50.
In connection with the December RDO, the Company issued the December Placement Agent Warrants to purchase up to approximately 228 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 $399.30.
In connection with the January 2024 RDO, the Company issued the January 2024 Warrants to purchase up to approximately 360,159 Warrants to purchase common stock at a purchase price of $40.26 per share. 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 $40.26 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 10,805 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 $50.325.
In connection with the July 2024 Offering, the Company issued to the placement agent the July Placement Agent Warrants to purchase up to approximately 15,152 shares of common stock. The July Placement Agent Warrants became exercisable January 18, 2025, expire July 22, 2029, and have an exercise price of $12.375 per share.
In connection with the 2024 PIPE, the Company issued 643,039 Series C Warrants and 643,039 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 are exercisable fortwo and one-half years from such approval. The initial exercise price for the Series C and Series D Warrants was $15.675 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.
(10) Warrants (continued)
The following table summarizes the Company’s outstanding warrants at December 31, 2024:
| | | | | | |
|---|---|---|---|---|---|
| · Number · Exercise Price | |||||
| Description · · of Shares · · Per Share | |||||
| IPO Underwriter Warrants | 12 | | $132,000 | ||
| February Placement Agent Warrants | 8 | | | 17,399 | |
| Consultant Warrants | 5 | | | 13,200 | |
| Series A-1 warrants | 1,516 | | | 4,290.00 | |
| Series A-2 warrants | 1,516 | | | 4,290.00 | |
| June Placement Agent Warrants | 107 | | | 5,775.00 | |
| September Underwriter Warrants | 652 | | | 841.50 | |
| December Placement Agent Warrants | | 228 | | | 399.30 |
| January 2024 Warrants | | 340,656 | | | 40.26 |
| January 2024 Placement Agent Warrants | | 10,805 | | | 50.33 |
| July 2024 Placement Agent Warrants | | 15,152 | | | 12.38 |
| December 2024 Series C Warrants | | 643,039 | | | 15.68 |
| December 2024 Series D Warrants | 643,039 | | 15.68 | ||
Approximately 19,505 of the January 2024 Warrants were exercised in the first half of 2024. In December 2024, the Company modified the exercise price applicable to certain Series A-1, Series A-2, and January 2024 Warrants to $12.441 per share. In connection with the modification, the Company recorded a deemed dividend in the aggregate of $30,601.
(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 115 shares of the Company’s common stock. The Board determined not to make any further awards under the 2020 Plan following the closing of the IPO. 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 190 shares of the Company’s common stock. The number of options or other awards available under the 2021 Plan increased approximately 25 shares in January 2022, approximately 25 shares in January 2023, approximately 951 shares in January 2024, and approximately 51,455 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).
(11) Share-Based Compensation (continued)
Of options awarded under the 2021 Plan, approximately 57,132 were outstanding at December 31, 2024.
At December 31, 2024, there were approximately 58 options outstanding under the 2020 Plan that were vested and exercisable and approximately 43,765 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, 2022 | 114 | $19,536.00 | 5.3 | ||
| Granted | 89 | | | 7,487.04 | 6.4 |
| Exercised | — | | | — | — |
| Forfeited | (12) | | | 15,147.66 | — |
| Outstanding at December 31, 2023 | 191 | | | 13,846.14 | 3.7 |
| Granted | 58,497 | | | 39.60 | 9.2 |
| Exercised | — | | | — | — |
| Forfeited | (1,556) | | 477.35 | — | |
| Outstanding at December 31, 2024 | 57,132 | | $78.80 | 9.4 | |
The intrinsic value of the outstanding options as of December 31, 2024, was $0.
Option Valuation
The assumptions that the Company used to determine the grant-date fair value of options granted in the years ended December 31, 2024 and 2023, were as follows:
| | | | | |
|---|---|---|---|---|
| | Year Ended December 31, | |||
| | | 2024 | | 2023 |
| Risk-free interest rate | 4.44% | | 4.01% - 4.72% | |
| Expected term (in years) | 6.0 | | 6.0 | |
| Expected volatility | | 128.8% | | 100.6% - 100.8% |
| Expected dividend yield | — | | — | |
| Fair value per share of underlying stock | | $1.06 - $1.08 | | $7,484.40 - $7,880.40 |
The weighted average grant date fair value per share of the options granted in the years ended December 31, 2024 and 2023, was $35.63 and $7,486.71, respectively.
The Company recorded share-based compensation expense of $1,699,999 and $1,036,889 during the years ended December 31, 2024 and 2023, respectively, all of which related to stock options. The remaining share-based compensation expense to be recognized in the future is $714,937 over approximately 1.01 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 approximately 6 shares of common stock. The number of shares of common stock available through the ESPP increased by approximately 3 shares in each of January 2022 through January 2025, and may be increased each subsequent year by up to approximately 3 shares.
(13) Net Loss per Share
The Company reported net losses for the years ended December 31, 2024 and 2023. 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:
| · · · · · · | ||||
|---|---|---|---|---|
| | Years ended December 31, | |||
| · 2024 · 2023 | ||||
| Basic and diluted net loss per share · · · · · · | ||||
| Net loss attributable to common stockholders | | $(16,785,572) | | $(18,546,095) |
| Weighted-average common shares outstanding | | 356,115 | | 5,424 |
| Net loss per share | | $(47.14) | | $(3,419.01) |
(14) Income Taxes
The Company’s federal and state provision (benefit) for income taxes was $0 and $0 for the years ended December 31, 2024 and 2023, respectively.
A reconciliation of income tax provision (benefit) computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows:
| · · · · · | ||
|---|---|---|
| | | Years Ended |
| | | December 31, |
| | 2024 | 2023 |
| Federal income tax benefit at statutory rate | 21.0% | 21.0% |
| State and local tax, net of federal benefit | 5.3% | 6.0% |
| Permanent differences | (4.4)% | 1.5% |
| Research and development credit | —% | 2.2% |
| Share-based compensation | (1.2)% | (1.0)% |
| Change in valuation allowance | (20.7)% | (29.7)% |
| Effective income tax rate | 0.0% | 0.0% |
(14) Income Taxes (continued)
Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets consist of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · · 2024 · 2023 | ||||||
| Net operating loss carryforwards | | $8,893,509 | | $5,880,202 | ||
| Capitalized research and development | | | 6,139,921 | | | 5,499,242 |
| Capitalized patent and other costs | | | 20,680 | | | 3,071 |
| Stock-based compensation | | | 303,419 | | | 118,733 |
| Accrued expenses | | | 40,210 | | | 14,125 |
| Fixed assets | | | 6,461 | | | 11,027 |
| Research and development tax credit carryforwards | | | 729,985 | | | 1,136,299 |
| Subtotal deferred tax assets before valuation allowance | | | 16,134,185 | | | 12,662,699 |
| Less valuation allowance | | | (16,134,185) | | | (12,662,699) |
| Deferred tax assets | | | — | | | — |
| | | | | | | |
| Deferred tax liability | | | | | | |
| Fixed assets | | | — | | | — |
| Net deferred taxes | | $— | | $— | ||
The Company had U.S. federal net operating loss (“NOL”) carryforwards of $32,654,129 and $21,556,006 for the years ended December 31, 2024 and 2023, respectively, which may be available to offset future taxable income. Federal NOL carryforwards generated in 2017 and prior of $38,297 will expire beginning in 2036. The remaining federal NOL carryforwards generated in 2018 and later do not expire. However, they are subject to the 80% limitation when utilized. The Company also had U.S. state NOL carryforwards of $32,217,433 and $21,415,201 for the years ended December 31, 2024 and 2023, respectively, which may be available to offset future taxable income and will expire beginning in 2036.
The Company had U.S. federal research and development tax credit carryforwards of $549,780 and $549,780 for the years ended December 31, 2024 and 2023, respectively, available to reduce future income tax liabilities. These will expire beginning in 2042. The Company also had U.S. state research and development tax credit carryforwards of $495,079 and $495,079 for the years ended December 31, 2024 and 2023, respectively, available to reduce future income tax liabilities. Of the U.S. state research and development tax credit carryforwards, $7,013 have an indefinite carryforward and the remainder expire beginning in 2036.
The Company has recorded a full valuation allowance against its net deferred tax assets as of December 31, 2024 and 2023, because the Company has determined that is it more likely than not that these assets will not be fully realized due to the significant uncertainty about the realization of the deferred tax asset until the Company can operate profitably. The Company experienced a net change in valuation allowance of $3,471,485 and $5,506,039 in the years ended December 31, 2024 and 2023, respectively.
(14) Income Taxes (continued)
Under the provisions of the Internal Revenue Code, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over athree-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or could result in a change in control in the future. The Company has not analyzed the historical or potential impact of its financings on beneficial ownership, and therefore, no determination has been made whether the net operating loss carryforward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there could be a reduction in the deferred tax asset with an offsetting reduction in the valuation allowance.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company’s tax years from 2020 to the present remain open for review. All open years may be examined to the extent that tax credits or NOL carryforwards are used in future periods. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2024 and 2023, the Company hadno accrued interest or penalties related to uncertain tax positions andno amounts have been recognized in the Company’s statements of operations.
A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Year Ended December 31, | |||||
| · 2024 · 2023 | |||||
| Balance at beginning of year | | $353 | | $— | |
| Increase for tax positions of prior years | | (125) | | | 228 |
| Increase based on tax positions related to current year | | — | | 125 | |
| Balance at end of year | | $228 | | $353 | |
Due to the Company’s valuation allowance, the $0.2 million of unrecognized tax benefits would not affect the effective tax rate, if recognized. It is the Company’s practice to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2024, we hadno accrued interest and penalties related to uncertain tax positions. We do not expect any material changes to the estimated amount of liability associated with the Company’s uncertain tax positions within the next 12 months.
The Protecting Americans from Tax Hikes Act of 2015 (“PATH Act”) made permanent the federal credit for increasing research activities (“R&D credit”). The PATH Act also included a provision that allowed a qualified small business to utilize a portion of its annual R&D credit as a payroll tax offset of up to $250,000 of the FICA payroll tax. The Company qualifies for this provision and has recorded payroll tax prepayments of $250,000 and $172,492 for 2022 and 2021, respectively. These benefits were able to be used beginning in the first quarter of 2023 and do not expire. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into law in 2020 and contained several new or changed income tax provisions. The Company has evaluated the tax provisions of the CARES Act and determined the impact to be either immaterial or not applicable. The Inflation Reduction Act of 2022 modified the PATH Act by adding an additional payroll tax offset of up to $250,000 against the Medicare payroll tax beginning in 2023. The Company is evaluating the benefits available under this provision.
Due to The Tax Cuts and Jobs Act of 2017 (TCJA), there was a change in the deductibility of research and experimental expenditures that took effect for taxable periods beginning after December 31, 2021. Prior to January 1, 2022, the Company expensed research and experimental expenditures under Section 174(a) in the year that it recognized the expense for financial reporting. The Company has adopted Section 174(b) for taxable years 2022 and beyond. Domestic and foreign research and experimental expenditures will be capitalized and amortized over periods no less than 60 months and 180 months, respectively.
(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 years ended December 31, 2024 and 2023.
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 has been identified as its Interim Chief Executive Officer and Chief Financial Officer (the “CODM”). 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 December 31, 2024, the Company evaluated subsequent events through April 15, 2025, the date on which those financial statements were issued.
On February 25, 2025, the Company’s shareholders approved issuance of the Series C and Series D Common Stock Purchase Warrants.
Between February 26, 2025, and March 21, 2025, all of the Company’s Series D warrants were exercised resulting in the issuance of 11,925,041 shares of common stock.
On March 23, 2025, the Company entered into a Placement Agency Agreement, or the March Agreement, with ThinkEquity LLC, or the Placement Agent, pursuant to which the Company agreed to issue and sell, directly to various investors, in a registered direct offering, or the March Offering, an aggregate of 10,250,000 shares, or the Shares, of common stock, or the Common Stock, and 10,250,000 Common Warrants, or the Common Warrants, to purchase 10,250,000 shares of Common Stock, at an aggregate offering price of $0.98 per share of Common Stock and accompanying Common Warrant. Additionally, as part of its compensation for acting as placement agent for the March Offering, the Company also agreed to issue to the Placement Agent warrants to purchase 512,500 shares of Common Stock, or the Placement Agent Warrants, and together with the Shares and the Common Warrants, the Securities. The Company received gross proceeds of approximately $10 million in connection with the March Offering, before deducting placement agent fees and other offering expenses payable by the Company. The March Offering closed on March 25, 2025. The Common Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $0.86 per share. The Placement Agent Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $1.07 per share.
After adjusting for exercises of the Series D warrants and receipt of the net proceeds from the March Offering, the Company estimates itspro forma stockholders’ equity at December 31, 2024, would have been as follows:
Stockholders equity (actual) at December 31, 2024($2,018,734)
Net proceeds from March Offering 8,811,900
Extinguishment of Series D warrant liability 6,023,526
Pro forma stockholders’ equity $12,816,692
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.