Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 20, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-40363 | ||
Entity Registrant Name | TRANSCODE THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 81-1065054 | ||
Entity Address, Address Line One | 6 Liberty Square, #2382 | ||
Entity Address, City or Town | Boston | ||
Entity Address State Or Province | MA | ||
Entity Address, Postal Zip Code | 02109 | ||
City Area Code | 857 | ||
Local Phone Number | 837-3099 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | RNAZ | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 4.4 | ||
Entity Common Stock, Shares Outstanding | 5,808,053 | ||
Entity Central Index Key | 0001829635 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | WithumSmith+Brown, PC | ||
Auditor Firm ID | 100 | ||
Auditor Location | East Brunswick, New Jersey |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 2,767,598 | $ 4,968,418 |
Grant receivable | 360,229 | |
Prepaid expenses and other current assets | 1,687,846 | 2,050,758 |
Total current assets | 4,455,444 | 7,379,405 |
Property and equipment, net of depreciation | 120,707 | 208,581 |
Right-of-use asset, net of amortization | 481,694 | |
Security deposit | 111,856 | |
Total assets | 5,169,701 | 7,587,986 |
Current liabilities: | ||
Accounts payable and accrued expenses | 3,051,259 | 4,347,290 |
Deferred grant income | 27,057 | 0 |
Short-term lease liability | 412,280 | |
Total current liabilities | 3,490,596 | 4,347,290 |
Long-term lease liability | 38,291 | |
Total liabilities | 3,528,887 | 4,347,290 |
Stockholders' equity: | ||
Preferred stock - $0.0001 par value; 10,000,000 authorized at December 31, 2023 and 2022; - 0 - shares issued and outstanding at December 31, 2023 and 2022 | ||
Common stock - $0.0001 par value, 290,000,000 shares authorized at December 31, 2023 and 2022; 627,448 and 16,222 shares issued and outstanding at December 31, 2023 and 2022, respectively | 63 | 2 |
Additional paid-in capital | 48,057,095 | 31,110,943 |
Accumulated deficit | (46,416,344) | (27,870,249) |
Total stockholders' equity | 1,640,814 | 3,240,696 |
Total liabilities and stockholders' equity | $ 5,169,701 | $ 7,587,986 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 290,000,000 | 290,000,000 |
Common stock, shares issued | 627,448 | 16,222 |
Common stock, share outstanding | 627,448 | 16,222 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses | ||
Research and development | $ 12,263,530 | $ 10,232,366 |
General and administrative | 7,154,986 | 8,401,462 |
Total operating expenses | 19,418,516 | 18,633,828 |
Operating loss | (19,418,516) | (18,633,828) |
Other income | ||
Grant income | 923,035 | 1,080,436 |
Interest expense | (55,899) | (31,986) |
Interest income | 5,285 | 20,410 |
Total other income | 872,421 | 1,068,860 |
Net loss | $ (18,546,095) | $ (17,564,968) |
Weighted-average common shares outstanding, Basic | 179,006 | 16,222 |
Weighted-average common shares outstanding, Diluted | 179,006 | 16,222 |
Net loss per share, Basic | $ (103.61) | $ (1,082.79) |
Net loss per share, Diluted | $ (103.61) | $ (1,082.79) |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance, beginning of period at Dec. 31, 2021 | $ 2 | $ 30,709,625 | $ (10,305,281) | $ 20,404,346 |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 16,131 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Net loss | (17,564,968) | (17,564,968) | ||
Exercise of stock options | 5,989 | $ 5,989 | ||
Exercise of stock options (in shares) | 91 | 91 | ||
Share based compensation | 395,329 | $ 395,329 | ||
Balance, end of period at Dec. 31, 2022 | $ 2 | 31,110,943 | (27,870,249) | 3,240,696 |
Balance, end of period (in shares) at Dec. 31, 2022 | 16,222 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Net loss | (18,546,095) | (18,546,095) | ||
Issuances of common stock, net | $ 61 | 15,909,263 | 15,909,324 | |
Issuances of common stock, net (in shares) | 611,226 | |||
Share based compensation | 1,036,889 | 1,036,889 | ||
Balance, end of period at Dec. 31, 2023 | $ 63 | $ 48,057,095 | $ (46,416,344) | $ 1,640,814 |
Balance, end of period (in shares) at Dec. 31, 2023 | 627,448 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (18,546,095) | $ (17,564,968) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 123,483 | 98,606 |
Amortization of right-of-use asset | 393,263 | |
Share-based compensation expense | 1,036,889 | 395,329 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | 362,912 | (144,444) |
Accounts payable and accrued expenses | (1,296,032) | 1,843,722 |
Deferred grant income | 27,057 | (30,528) |
Grants receivable | 360,229 | (360,229) |
Security deposit | (111,856) | |
Operating lease liability | (424,385) | |
Net cash used in operating activities | (18,074,535) | (15,762,512) |
Cash flows from investing activities: | ||
Purchase of equipment | (35,609) | (100,919) |
Net cash used in investing activities | (35,609) | (100,919) |
Cash flows from financing activities: | ||
Net proceeds from sales of common stock | 15,909,324 | |
Proceeds from exercise of stock options | 5,989 | |
Net cash provided by financing activities | 15,909,324 | 5,989 |
Net change in cash | (2,200,820) | (15,857,442) |
Cash, beginning of period | 4,968,418 | 20,825,860 |
Cash, end of period | 2,767,598 | 4,968,418 |
Supplemental disclosure of cash flow | ||
Interest related to insurance premium payment plan | 32,861 | $ 37,115 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Right-of-use assets obtained in exchange for operating lease liabilities | $ 874,957 |
Nature of Business and Liquidit
Nature of Business and Liquidity | 12 Months Ended |
Dec. 31, 2023 | |
Nature of Business and Liquidity | |
Nature of Business and Liquidity | (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. 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.” The Company issued approximately 8,984 shares of common stock in connection with the IPO, including exercise of the underwriter’s over-allotment option, at an initial offering price of $3,200.00 per share. 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. In connection with the IPO, the Company also granted the underwriter warrants to purchase up to approximately 391 shares of Company common stock at an exercise price of $4,000.00 per share (125% of the initial public offering price). 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. 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 year ended December 31, 2023, net cash used in operating activities was approximately $18.0 (1) Nature of Business and Liquidity (continued) The Company plans to expand development of its lead therapeutic candidate and other candidates, and to explore strategic partnerships. Management believes that current cash and the net proceeds of a January 2024 equity offering are sufficient to fund operations and capital requirements into the late third or early fourth quarter of 2024, 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, 2023, 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 an SBIR Award 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (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, 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. (2) Summary of Significant Accounting Policies (continued) (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, 2023 and 2022, 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, the Company received an award (the “Award”) 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 Award, and the Company does not lose control over the work performed under the Award, the Company deems the Award funds as a contribution. 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. (2) Summary of Significant Accounting Policies (continued) (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. (2) Summary of Significant Accounting Policies (continued) 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 August 2020, the FASB issued ASU 2020-06, “Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in U.S. GAAP. The ASU’s amendments are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The Company’s adoption of ASU 2020-06 on January 1, 2023, 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 of one 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 “2024 Reverse Split”) previously approved by the Board and stockholders of the Company. The 2024 Reverse Split was at a ratio of one 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 two 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. (2) Summary of Significant Accounting Policies (continued) (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”), 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. As the warrants issued upon Company financings in 2023 meet the criteria for equity classification under ASC 815, those warrants were classified as equity as of December 31, 2023. No warrants were issued in 2022. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | (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. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | (4) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: December 31, December 31, 2023 2022 Prepaid operating expenses $ 116,607 $ 122,428 Contract manufacturers and research organizations 717,686 241,111 Insurance premiums 431,061 1,255,317 Prepaid FICA 422,492 422,492 Deposits — 9,410 $ 1,687,846 $ 2,050,758 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Property and Equipment | (5) Property and Equipment Property and equipment, net consisted of the following: December 31, December 31, 2023 2022 Laboratory and computer equipment $ 384,050 $ 348,441 Less accumulated depreciation (263,343) (139,860) Total property and equipment, net $ 120,707 $ 208,581 Depreciation expense for the years ended December 31, 2023 and 2022, was $123,483 and $98,606, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | (6) Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consisted of the following: December 31, December 31, 2023 2022 Professional and general consulting fees $ 375,550 $ 758,816 R&D-related – CMOs, CROs, supplies, equipment and consulting 1,260,578 2,397,038 General expenses 295,508 124,676 Insurance premiums 400,236 844,283 Payroll and benefits 589,404 164,657 Accrued license payments 129,983 57,820 $ 3,051,259 $ 4,347,290 At December 31, 2023 and 2022, the Company’s outstanding payables to CROs or CMOs included above were $1,020,875 and $2,030,347, respectively. See Note 8 for further information regarding the accrued license payments. |
Grant Income
Grant Income | 12 Months Ended |
Dec. 31, 2023 | |
Grant Income | |
Grant Income | (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 $923,035 and $1,080,436 for the years ended December 31, 2023 and 2022, respectively. The Company recorded grant income receivable of $0 at December 31, 2023, and $360,229 at December 31, 2022. The Company had deferred grant income of $27,057 and $0 at December 31, 2023 and 2022, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | (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 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, 2023. 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, 2023 Weighted average remaining lease term (years) 1.08 Weighted average discount rate 3.6 % Year ending December 31, 2024 $ 422,464 2025 38,291 Total undiscounted lease payments 460,755 Imputed interest (10,184) Lease liability $ 450,571 Rent expense for the years ended December 31, 2023 and 2022, was $575,192 and $329,684, respectively. (8) Commitments and Contingencies (continued) (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, 2023 and 2022, 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. (8) Commitments and Contingencies (continued) Accrued License Obligations At December 31, 2023 and 2022, the Company had accrued $129,983 and $57,820, 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 a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center (“MD Anderson”). Under the collaboration, the Company anticipates 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 will also provide preclinical work under the collaboration. The details of clinical and preclinical work are to be mutually agreed by the parties prior to commencing work. The Company has 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 fourth (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 $2,483,700. 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 off four employees. This lowered the Company’s headcount to (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, 2023 and 2022, 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 a claim by an investment bank that it is entitled to fees, a claim which the Company rigorously disputes. (8) Commitments and Contingencies (continued) (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, 2023 and 2022. (g) Risks and Uncertainties 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. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | (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, and on May 22, 2023, to effect the 2023 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, 2023 and 2022, the Company had 627,448 and 16,222 shares of common stock issued outstanding On February 16, 2023, the Company entered into a Securities Purchase Agreement with certain purchasers named therein pursuant to which the Company sold approximately 3,558 shares of common stock in a registered direct offering at a purchase price of $421.60 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 249 shares of common stock (the “February Placement Agent Warrants”). The February Placement Agent Warrants became exercisable commencing six months following the date of issuance, expire five years following the date of sale and have an exercise price per share of $527.00 (see Note 10). In April and May 2023, the Company sold an aggregate of approximately 2,750 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 legal and printing expenses the Company incurred of $75,418. 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 2,475 shares of common stock, approximately 47,525 pre-funded warrants (“PFWs”), together with accompanying 50,000 Series A-1 Warrants to purchase common stock (the “Series A-1 Warrants”), and 50,000 Series A-2 Warrants to purchase common stock (the “Series A-2 Warrants”) in a registered direct offering at a purchase price of $140.00 per share (or $139.60 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 for three years at an exercise price of $130.00 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 $0.01 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 3,500 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 $175.00 (see Note 10). On September 26, 2023, the Company entered into an underwriting agreement pursuant to which it issued and sold approximately 17,500 shares of common stock and approximately 404,075 PFWs, including the partial exercise of the underwriter’s overallotment option, in a public offering at a purchase price of $20.40 per share (or $20.00 per PFW) (the “September Offering”). The overallotment option provided the underwriter the right to purchase up to approximately 58,480 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 177,176 September Offering PFWs had been exercised. On October 4, 2023, the underwriter exercised the overallotment option to purchase approximately 8,348 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 21,496 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 $25.50 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 125,000 shares of common stock in a registered direct offering at a purchase price of $9.68 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 7,500 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 $12.10 (see Note 10). (b) Common Stock i. 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, 2023, nor at any other time through the date of these financial statements. (9) Stockholders’ Equity (continued) ii. 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. Holders of common stock are entitled to one 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. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Warrants | |
Warrants | (10) Warrants All of the warrants described below were outstanding as of December 31, 2023, and are accounted for as a component of stockholders’ equity. All prefunded warrants issued in 2023 have been exercised. In connection with the IPO, the Company granted the underwriter warrants (the “IPO Underwriter Warrants”) to purchase up to approximately 391 shares of Company common stock at an exercise price of $4,000.00 per share, which amount is 125% of the initial public offering price. The IPO Underwriter Warrants have a five-year In connection with the February RDO, the Company issued the February Placement Agent Warrants to purchase up to approximately 249 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 $527.20 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 156 shares of common stock at $400.00 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 50,000 Series A-1 Warrants and 50,000 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 $130.00 per share. The Company also issued warrants to the June RDO placement agent to purchase up to 3,500 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 $175.20 per share. In connection with the September Offering, the Company issued warrants to the underwriter to purchase up to approximately 21,496 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 $25.50. In connection with the December RDO, the Company issued the December Placement Agent Warrants to purchase up to 7,500 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 $12.10. (10) Warrants (continued) The following table summarizes the Company’s outstanding warrants at December 31, 2023: Number Exercise Price Description of Shares Per Share IPO Underwriter Warrants 391 $ 4,000.00 February Placement Agent Warrants 249 527.20 Consultant Warrants 156 400.00 Series A-1 warrants 50,000 130.00 Series A-2 warrants 50,000 130.00 June Placement Agent Warrants 3,500 175.20 September Underwriter Warrants 21,496 25.50 December Placement Agent Warrants 7,500 12.10 |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Compensation | |
Share-Based Compensation | (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 2,242 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 6,250 shares of the Company’s common stock. The number of options or other awards available under the 2021 Plan increased 807 shares in January 2022, 811 in January 2023, and 1,569 in January 2024. 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 generally two 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 (11) Share-Based Compensation (continued) Of options awarded under the 2021 Plan, approximately 4,243 were outstanding at December 31, 2023. At December 31, 2023, there were 2,050 options outstanding under the 2020 Plan that were vested and exercisable and 3,469 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, 2021 2,142 $ 264.00 5.2 Granted 1,720 976.00 6.4 Exercised (91) 64.00 — Forfeited — — — Outstanding at December 31, 2022 3,771 592.00 5.3 Granted 2,911 226.88 0.9 Exercised — — — Forfeited (393) 459.02 — Outstanding at December 31, 2023 6,289 $ 419.58 3.7 The intrinsic value of the outstanding options as of December 31, 2023, 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, 2023 and 2022, were as follows: Years Ended December 31, 2023 2022 Risk-free interest rate 4.01% - 4.72 % 1.38% - 4.12 % Expected term (in years) 6.0 3.5 - 10.0 Expected volatility 100.6% - 100.8 % 93.2 % Expected dividend yield — — Fair value per share of underlying stock $ 226.80 - $238.80 $ 408.00 - $1,960.00 (11) Share-Based Compensation (continued) The weighted average grant date fair value per share of the options granted in the years ended December 31, 2023 and 2022, was $226.87 and $974.22, respectively. The Company recorded share-based compensation expense of $1,013,527 and $395,329 during the years ended December 31, 2023 and 2022, respectively, all of which related to stock options. The remaining share-based compensation expense to be recognized in the future is $183,765 over approximately 2.3 years. |
Employee Stock Purchase Plan
Employee Stock Purchase Plan | 12 Months Ended |
Dec. 31, 2023 | |
Employee Stock Purchase Plan | |
Employee Stock Purchase Plan | (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 188 shares of common stock. The number of shares of common stock available through the ESPP increased by approximately 113 shares in each of January 2022, January 2023, and January 2024 and may be increased each subsequent year by up to approximately 113 shares. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss per Share | |
Net Loss per Share | (13) Net Loss per Share The Company reported net losses for the years ended December 31, 2023 and 2022. 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. The following table sets forth the computation of basic and diluted loss per share: Years ended December 31, 2023 2022 Basic and diluted loss per share Net loss $ (18,546,095) $ (17,564,968) Weighted-average common shares outstanding 179,006 16,222 Net loss per share $ (103.61) $ (1,082.79) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | (14) Income Taxes The Company’s federal and state provision (benefit) for income taxes was $0 and $0 for the years ended December 31, 2023 and 2022, 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, 2023 2022 Federal income tax benefit at statutory rate 21.0 % 21.0 % State and local tax, net of federal benefit 6.0 % 6.3 % Permanent differences 1.5 % (0.1) % Research and development credit 2.2 % 2.4 % Share-based compensation (1.0) % (0.4) % Change in valuation allowance (29.7) % (29.2) % 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, 2023 2022 Net operating loss carryforwards $ 5,880,202 $ 3,434,543 Capitalized research and development 5,499,242 3,166,280 Capitalized patent and other costs 3,071 5,219 Stock-based compensation 118,733 69,592 Accrued expenses 14,125 24,521 Fixed assets 11,027 1,889 Research and development tax credit carryforwards 1,136,299 454,616 Subtotal deferred tax assets before valuation allowance 12,662,699 7,156,660 Less valuation allowance (12,662,699) (7,156,660) Deferred tax assets — — Deferred tax liability Fixed assets — — Net deferred taxes $ — $ — The Company had U.S. federal net operating loss (“NOL”) carryforwards of $21,556,006 and $12,277,816 for the years ended December 31, 2023 and 2022, 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 $21,415,201 and $12,137,011 for the years ended December 31, 2023 and 2022, 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 $864,408 and $549,780 for the years ended December 31, 2023 and 2022, 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 $758,417 and $495,079 for the years ended December 31, 2023 and 2022, 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, 2023 and 2022, 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 $5,506,039 and $5,136,825 in the years ended December 31, 2023 and 2022, 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 a three-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 2019 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, 2023 and 2022, the Company had no accrued interest or penalties related to uncertain tax positions and no 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, 2023 2022 Balance at beginning of year $ — $ — Increase for tax positions of prior years 228 — Increase based on tax positions related to current year 125 — Balance at end of year $ 353 $ — Due to the Company’s valuation allowance, the $0.4 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, 2023, the Company had no accrued interest and penalties related to uncertain tax positions. The Company does 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 $250,000 for 2023 and 2022, respectively. These benefits are 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 expects to be able to recognize 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. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | (15) Subsequent Events For its financial statements as of December 31, 2023, the Company evaluated subsequent events through April 1, 2024, the date on which those financial statements were issued. Restructuring As part of the Restructuring, Michael Dudley, the Company’s then President, Chief Executive Officer and Director, resigned his positions with the Company effective January 13, 2024. Reverse Stock Splits 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 “2024 Reverse Split”) previously approved by the Board and stockholders of the Company. The 2024 Reverse Split was at a ratio of one January Offering On January 18, 2024, the Company entered into Securities Purchase Agreements with investors named therein pursuant to which the Company issued and sold 428,924 shares of common stock, 5,513,699 PFWs, together with accompanying warrants to purchase 11,885,246 shares of common stock in a registered direct offering at a purchase price of $1.22 per share (or $1.21 per PFW) (the “January Offering”). Each share of common stock, or each PFW in lieu thereof, sold in the January Offering was sold together with two common stock purchase warrants (the “January Warrants”). Each January Warrant entitles the holder to purchase one share of Company common stock per warrant at an exercise price of $1.22 per share. The shares of common stock and January Warrants were immediately separable and were issued separately in the offering. The January Warrants became exercisable on issuance and are exercisable for three and one-half years In connection with the January Offering, the Company also issued warrants to the placement agent to purchase up to 356,557 shares of Company common stock (the “January Placement Agent Warrants”). The January Placement Agent Warrants became exercisable on issuance, expire three and one-half years Nasdaq Listing On January 31, 2024, the Company received notice from Nasdaq that it had determined that the Company had regained compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) (the Equity Rule) for continued listing on the Nasdaq Capital Market. Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), the Company is subject to a mandatory panel monitor through January 26, 2025. The Nasdaq notice also stated that if, within the one-year monitoring period, the Staff finds the Company again out of compliance with the Equity Rule that was the subject of the exception, notwithstanding Rule 5810(c)(2), the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, the Staff will issue a Delist Determination Letter and the Company will have an opportunity to request a new hearing with the initial Hearing Panel or a newly convened Hearing Panel if the initial Panel is unavailable. The Company will have the opportunity to respond/present to the Hearing Panel as provided by Listing Rule 5815(d)(4)(C). The Company’s securities may at that time be delisted from Nasdaq. (15) Subsequent Events (continued) Additionally, on November 7, 2023, the Company received a letter from the Staff notifying the Company that for the 30 consecutive business day period between September 26, 2023, through November 6, 2023, the Company’s common stock had not maintained a minimum closing bid price of $1.00 per share, or the Minimum Bid Price Requirement, required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). Nasdaq provided the Company an initial period of 180 calendar days, or until May 6, 2024, or the Compliance Date, to regain compliance with the Minimum Bid Price Requirement. If, at any time during this 180-day period, the closing bid price for the Company’s common stock is $1.00 per share or more for a minimum of 10 consecutive business days, or such longer period up to 20 consecutive business days as may be determined by the Staff in its discretion, the Staff will provide the Company written notification that it has complied with the Minimum Bid Price Requirement. On January 16, 2024, the Company effected a 1 If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, it may be eligible for an additional 180 calendar day compliance period. To qualify, the Company would be required to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and would need to provide written notice to Nasdaq of its intention to cure the deficiency during the additional compliance period. If it appears to the Staff that the Company will not be able to cure the Minimum Bid Price deficiency, the Staff will provide written notice to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to the Panel. There can be no assurance that if the Company does appeal any Staff delisting determination to the Panel, such appeal would be successful. In the event of a delisting from the Nasdaq Capital Market, the Company may seek to have its stock traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or, together, Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, the Company’s stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, institutional investors are usually prohibited from investing in OTC stocks, and it might be more challenging to raise capital. In light of the Company’s financial position and need to raise additional capital, a delisting from the Nasdaq Capital Market would materially limit the Company’s ability to obtain additional equity capital. The Company may need to seek an in-court or out-of-court restructuring of its liabilities. In the event of such restructuring activities, holders of the Company’s common stock and other securities will likely suffer a total loss of their investment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | (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”). |
Use of Estimates | (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, 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. |
Basic and Diluted Loss per Share | (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. |
Cash | (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. |
Fair Value of Financial Instruments | (e) Fair Value of Financial Instruments The Company’s financial instruments at December 31, 2023 and 2022, 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. |
Research and Development | (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. |
Grant Income | (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, the Company received an award (the “Award”) 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 Award, and the Company does not lose control over the work performed under the Award, the Company deems the Award funds as a contribution. 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. |
Share-Based Compensation | (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. |
Property and Equipment | (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. |
Income Taxes | (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. |
Emerging Growth Company Status | (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. |
Recent Accounting Pronouncement | (l) Recent Accounting Pronouncement In August 2020, the FASB issued ASU 2020-06, “Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in U.S. GAAP. The ASU’s amendments are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The Company’s adoption of ASU 2020-06 on January 1, 2023, did not have a material impact on the Company’s financial statements. |
Reverse Stock Split | (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 of one 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 “2024 Reverse Split”) previously approved by the Board and stockholders of the Company. The 2024 Reverse Split was at a ratio of one 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 two reverse stock splits. |
Collaboration Agreements | (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. |
Leases | (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. |
Warrant Accounting | (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”), 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. As the warrants issued upon Company financings in 2023 meet the criteria for equity classification under ASC 815, those warrants were classified as equity as of December 31, 2023. No warrants were issued in 2022. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of estimated useful life of property and equipment | 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 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | December 31, December 31, 2023 2022 Prepaid operating expenses $ 116,607 $ 122,428 Contract manufacturers and research organizations 717,686 241,111 Insurance premiums 431,061 1,255,317 Prepaid FICA 422,492 422,492 Deposits — 9,410 $ 1,687,846 $ 2,050,758 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Schedule of property and equipment | December 31, December 31, 2023 2022 Laboratory and computer equipment $ 384,050 $ 348,441 Less accumulated depreciation (263,343) (139,860) Total property and equipment, net $ 120,707 $ 208,581 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | December 31, December 31, 2023 2022 Professional and general consulting fees $ 375,550 $ 758,816 R&D-related – CMOs, CROs, supplies, equipment and consulting 1,260,578 2,397,038 General expenses 295,508 124,676 Insurance premiums 400,236 844,283 Payroll and benefits 589,404 164,657 Accrued license payments 129,983 57,820 $ 3,051,259 $ 4,347,290 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Schedule of lease cost | Year Ended Operating Leases December 31, 2023 Weighted average remaining lease term (years) 1.08 Weighted average discount rate 3.6 % Year ending December 31, 2024 $ 422,464 2025 38,291 Total undiscounted lease payments 460,755 Imputed interest (10,184) Lease liability $ 450,571 |
Schedule of milestone payments the company shall pay to licensor | 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 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Warrants | |
Summary of company's outstanding or issuable warrant | Number Exercise Price Description of Shares Per Share IPO Underwriter Warrants 391 $ 4,000.00 February Placement Agent Warrants 249 527.20 Consultant Warrants 156 400.00 Series A-1 warrants 50,000 130.00 Series A-2 warrants 50,000 130.00 June Placement Agent Warrants 3,500 175.20 September Underwriter Warrants 21,496 25.50 December Placement Agent Warrants 7,500 12.10 |
Share-Based Compensation (Table
Share-Based Compensation (Table) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Compensation | |
Schedule of options to purchase common stock | Weighted average Weighted exercise average Number of price contractual shares per share term (years) Outstanding at December 31, 2021 2,142 $ 264.00 5.2 Granted 1,720 976.00 6.4 Exercised (91) 64.00 — Forfeited — — — Outstanding at December 31, 2022 3,771 592.00 5.3 Granted 2,911 226.88 0.9 Exercised — — — Forfeited (393) 459.02 — Outstanding at December 31, 2023 6,289 $ 419.58 3.7 |
Schedule of assumptions to determine the grant-date fair value of options granted | Years Ended December 31, 2023 2022 Risk-free interest rate 4.01% - 4.72 % 1.38% - 4.12 % Expected term (in years) 6.0 3.5 - 10.0 Expected volatility 100.6% - 100.8 % 93.2 % Expected dividend yield — — Fair value per share of underlying stock $ 226.80 - $238.80 $ 408.00 - $1,960.00 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss per Share | |
Schedule of computation of basic and diluted loss per share | Years ended December 31, 2023 2022 Basic and diluted loss per share Net loss $ (18,546,095) $ (17,564,968) Weighted-average common shares outstanding 179,006 16,222 Net loss per share $ (103.61) $ (1,082.79) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of statutory federal income tax rate to income taxes | Years Ended December 31, 2023 2022 Federal income tax benefit at statutory rate 21.0 % 21.0 % State and local tax, net of federal benefit 6.0 % 6.3 % Permanent differences 1.5 % (0.1) % Research and development credit 2.2 % 2.4 % Share-based compensation (1.0) % (0.4) % Change in valuation allowance (29.7) % (29.2) % Effective income tax rate 0.0 % 0.0 % |
Schedule of company's deferred tax assets | December 31, 2023 2022 Net operating loss carryforwards $ 5,880,202 $ 3,434,543 Capitalized research and development 5,499,242 3,166,280 Capitalized patent and other costs 3,071 5,219 Stock-based compensation 118,733 69,592 Accrued expenses 14,125 24,521 Fixed assets 11,027 1,889 Research and development tax credit carryforwards 1,136,299 454,616 Subtotal deferred tax assets before valuation allowance 12,662,699 7,156,660 Less valuation allowance (12,662,699) (7,156,660) Deferred tax assets — — Deferred tax liability Fixed assets — — Net deferred taxes $ — $ — |
Schedule of company's unrecognized tax benefit | A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2023 2022 Balance at beginning of year $ — $ — Increase for tax positions of prior years 228 — Increase based on tax positions related to current year 125 — Balance at end of year $ 353 $ — |
Nature of Business and Liquid_2
Nature of Business and Liquidity - IPO (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 13, 2021 | Dec. 31, 2023 | Feb. 28, 2023 |
Nature of Business and Liquidity | |||
Number of shares of common stock called by warrants | 391 | 249 | |
Exercise price | $ 4,000 | ||
IPO | |||
Nature of Business and Liquidity | |||
Gross proceeds | $ 28,800 | ||
Shares issued (in shares) | 8,984 | ||
Price per share (in dollars per share) | $ 3,200 | ||
Net proceeds | $ 25,400 | ||
Number of shares of common stock called by warrants | 391 | ||
Exercise price | $ 4,000 | ||
Redemption premium (as a percent) | 125% | ||
Shares converted (in shares) | 1,335 |
Nature of Business and Liquid_3
Nature of Business and Liquidity - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Nature of Business and Liquidity | ||
Net cash used in operating activities | $ 18,074,535 | $ 15,762,512 |
Net loss | (18,546,095) | (17,564,968) |
Accumulated deficit | (46,416,344) | (27,870,249) |
Cash | $ 2,767,598 | $ 4,968,418 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Estimated useful life of property and equipment (Details) | 12 Months Ended | ||
Jan. 16, 2024 | Dec. 31, 2023 | Dec. 31, 2022 shares | |
Summary of Significant Accounting Policies | |||
Reverse stock split ratio | 0.05 | ||
Warrant issued | 0 | ||
Subsequent Events | |||
Summary of Significant Accounting Policies | |||
Reverse stock split ratio | 0.025 | ||
Laboratory equipment | |||
Summary of Significant Accounting Policies | |||
Estimated useful life | 3 years | ||
Furniture and fixtures | |||
Summary of Significant Accounting Policies | |||
Estimated useful life | 5 years | ||
Computer and office equipment | |||
Summary of Significant Accounting Policies | |||
Estimated useful life | 3 years |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Prepaid operating expenses | $ 116,607 | $ 122,428 |
Contract manufacturers and research organizations | 717,686 | 241,111 |
Insurance premiums | 431,061 | 1,255,317 |
Prepaid FICA | 422,492 | 422,492 |
Deposits | 9,410 | |
Prepaid expenses and other current assets | $ 1,687,846 | $ 2,050,758 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment | ||
Laboratory and computer equipment | $ 384,050 | $ 348,441 |
Less accumulated depreciation | (263,343) | (139,860) |
Total property and equipment, net | 120,707 | 208,581 |
Depreciation expense | $ 123,483 | $ 98,606 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts Payable and Accrued Expenses | ||
Professional and general consulting fees | $ 375,550 | $ 758,816 |
R&D-related - CMOs, CROs, supplies, equipment and consulting | 1,260,578 | 2,397,038 |
General expenses | 295,508 | 124,676 |
Insurance premiums | 400,236 | 844,283 |
Payroll and benefits | 589,404 | 164,657 |
Accrued license payments | 129,983 | 57,820 |
Total accounts payable and accrued expenses | 3,051,259 | 4,347,290 |
Outstanding payables to CROs or CMOs | $ 1,020,875 | $ 2,030,347 |
Grant Income (Details)
Grant Income (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Apr. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Apr. 30, 2023 | May 31, 2022 | May 31, 2021 | |
Grant Income | ||||||
Expected award amount | $ 2,392,845 | |||||
Grant term (in years) | 3 years | |||||
Deferred grant income | $ 870,684 | $ 1,129,316 | $ 308,861 | |||
Grant income recognized | $ 923,035 | $ 1,080,436 | ||||
Grant income receivable | 0 | 360,229 | ||||
Deferred grant income | $ 27,057 | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 1 Months Ended | 12 Months Ended | ||
Feb. 01, 2023 USD ($) | Mar. 31, 2021 USD ($) ft² | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2023 $ / ft² | |
Leases | ||||
Rent payments (per month) | $ 6,521 | |||
Rental expenses year one | $ / ft² | 37,285 | |||
Rental expenses year two | $ / ft² | 38,403 | |||
Rental expenses year three | $ / ft² | 39,559 | |||
Massachusetts Biomedical Initiatives, Inc. ("MBI") | ||||
Leases | ||||
Real estate (in sq ft) | ft² | 2,484 | 4,837 | ||
Rent payments (per month) | $ 6,521 | |||
Additional sublease payment per month | $ 650 | |||
Total additional sublease payment per month | 10,276 | |||
Operating lease liability | $ 874,957 | |||
Total sublease commitment | $ 874,957 | |||
Massachusetts Biomedical Initiatives, Inc. ("MBI") | Operating Expense | ||||
Leases | ||||
Rent payments (per month) | $ 3,105 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of operating lease (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies | ||
Weighted average remaining lease term (years) | 1 year 29 days | |
Weighted average discount rate | 3.60% | |
2024 | $ 422,464 | |
2025 | 38,291 | |
Total undiscounted lease payments | 460,755 | |
Imputed interest | (10,184) | |
Lease liability | 450,571 | |
Rent expense | $ 575,192 | $ 329,684 |
Commitments and Contingencies_3
Commitments and Contingencies - License Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2020 | Oct. 31, 2020 | Nov. 30, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies | |||||
One-time non-refundable fee of license agreement | $ 50,000 | ||||
Reimbursement of licensor's patent costs at execution of the license | 145,000 | ||||
Minimum annual license fee | $ 25,000 | ||||
Period within each anniversary of the effective date of the license that minimum annual license fee must be paid | 60 days | ||||
Maximum total milestone payments | $ 1,550,000 | ||||
Period within which the milestone payments should be paid upon achievement of the milestone | 60 days | ||||
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 | ||||
Royalties calculated as a percentage to on net sales of licensed products for therapeutic products or processes | 3% | ||||
Royalties calculated as a percentage to on net sales of licensed products for clinical diagnostic products and processes | 6% | ||||
Royalties calculated as a percentage of any and all sublicense income | 30% | ||||
Notice period for terminating License | 90 days | ||||
Period after the first commercial sale that the License shall continue if not terminated by the company | 10 years | ||||
Royalty percentage beyond the term of the License | 1.50% | ||||
Minimum annual license fee for Patent Family 1 | $ 30,000 | $ 25,000 | |||
Minimum annual license fee related to Patent Family 2 | $ 10,000 | ||||
Accrued license obligations | $ 129,983 | $ 57,820 |
Commitments and Contingencies_4
Commitments and Contingencies - Collaboration Agreement and Litigation (Details) | 12 Months Ended | ||
Jul. 29, 2022 USD ($) | Dec. 31, 2023 USD ($) employee | Dec. 31, 2022 USD ($) employee | |
Commitments and Contingencies | |||
Aggregate amount of severance | $ 424,576 | ||
Number of Positions Eliminated | employee | 4 | ||
Number of Employees | employee | 11 | 19 | |
Employee Severance | Maximum | |||
Commitments and Contingencies | |||
Aggregate amount of severance | $ 2,483,700 | ||
Collaboration Agreement | |||
Commitments and Contingencies | |||
Amount paid to company as prepaid expenses | 250,000 | ||
Collaboration Agreement | The University of Texas M. D. Anderson Cancer Center ("MD Anderson") | |||
Commitments and Contingencies | |||
Collaboration agreement term | 5 years | ||
Amount the company has committed to pay | $ 10,000,000 | ||
Amount the company has committed to pay in year one | 500,000 | ||
Subsequent payments made in first anniversary | 2,000,000 | ||
Subsequent payments made in second anniversary | 2,500,000 | ||
Subsequent payments made in third anniversary | 2,500,000 | ||
Subsequent payments made in fourth anniversary | $ 2,500,000 | ||
Total expenses incurred under the arrangement | $ 0 | $ 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 1 Months Ended | 12 Months Ended | ||||||||||||
Sep. 26, 2023 $ / shares shares | Jun. 06, 2023 USD ($) $ / shares shares | Feb. 16, 2023 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 $ / shares shares | May 31, 2023 USD ($) shares | Apr. 30, 2023 USD ($) shares | Dec. 31, 2023 USD ($) Vote $ / shares shares | Oct. 04, 2023 shares | Jun. 09, 2023 $ / shares | Jun. 08, 2023 $ / shares shares | Feb. 28, 2023 shares | Dec. 31, 2022 $ / shares shares | Apr. 27, 2021 $ / shares shares | |
Stockholders' Equity | ||||||||||||||
Maximum number of shares which the Company is authorized to issue | 300,000,000 | |||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||
Accumulated restricted common stock outstanding | 627,448 | 16,222 | ||||||||||||
Accumulated restricted common stock issued | 627,440 | 16,222 | ||||||||||||
Preferred stock, shares issued | 0 | 0 | ||||||||||||
Net proceeds from sales of common stock | $ | $ 15,909,324 | |||||||||||||
Number of warrants purchased | 391 | 249 | ||||||||||||
Term of warrants | 5 years | 5 years | ||||||||||||
Exercise price | $ / shares | $ 4,000 | |||||||||||||
Common Stock - Dividends and Voting | ||||||||||||||
Cash dividends were declared or paid | $ | $ 0 | |||||||||||||
Common stock voting rights per share | Vote | 1 | |||||||||||||
Pre-funded warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Issuances of common stock, net (in shares) | 50,000 | |||||||||||||
Number of warrants sold | 21,496 | |||||||||||||
Price per share (in dollars per share) | $ / shares | $ 139.60 | |||||||||||||
Series A warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Term of warrants | 3 years | 3 years | ||||||||||||
Exercise price | $ / shares | $ 130 | $ 130 | ||||||||||||
Series A-1 Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 50,000 | 50,000 | ||||||||||||
Exercise price | $ / shares | $ 130 | |||||||||||||
Series A-2 Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 50,000 | |||||||||||||
Exercise price | $ / shares | $ 130 | |||||||||||||
June Placement Agent Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 3,500 | 3,500 | ||||||||||||
Term of warrants | 3 years | |||||||||||||
Exercise price | $ / shares | $ 175.20 | $ 175.20 | ||||||||||||
February Placement Agent Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 249 | |||||||||||||
Exercise price | $ / shares | $ 527 | $ 527.20 | ||||||||||||
December Placement Agent Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 7,500 | |||||||||||||
Exercise price | $ / shares | $ 12.10 | |||||||||||||
Underwriter Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Exercise price | $ / shares | $ 25.50 | |||||||||||||
Underwriter Warrants | Maximum | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Commencement period for exercise of warrants, following the date of issuance | 180 days | |||||||||||||
Term of warrants | 5 years | |||||||||||||
RDO PFW | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Price per share (in dollars per share) | $ / shares | $ 0.01 | |||||||||||||
White Lion Purchase Agreement | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Net proceeds from sales of common stock | $ | $ 518,844 | $ 518,844 | ||||||||||||
Issuances of common stock, net (in shares) | 2,750 | 2,750 | ||||||||||||
Aggregate legal and printing expenses | $ | $ 75,418 | $ 75,418 | ||||||||||||
Securities Purchase Agreement | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Commencement period for exercise of warrants, following the date of issuance | 6 months | |||||||||||||
Issuances of common stock, net (in shares) | 2,475 | |||||||||||||
Net proceeds | $ | $ 6,100,000 | |||||||||||||
Price per share (in dollars per share) | $ / shares | $ 140 | |||||||||||||
Securities Purchase Agreement | Pre-funded warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants sold | 47,525 | |||||||||||||
Securities Purchase Agreement | Series A-1 Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants sold | 50,000 | |||||||||||||
Securities Purchase Agreement | Series A-2 Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants sold | 50,000 | |||||||||||||
Securities Purchase Agreement | June Placement Agent Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 3,500 | |||||||||||||
Term of warrants | 3 years | |||||||||||||
Exercise price | $ / shares | $ 175 | |||||||||||||
Securities Purchase Agreement | December Placement Agent Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 7,500 | |||||||||||||
Term of warrants | 5 years | |||||||||||||
Exercise price | $ / shares | $ 12.10 | |||||||||||||
Securities Purchase Agreement | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Aggregate of direct offering | 3,558 | 125,000 | ||||||||||||
Sale of stock exercise price | $ / shares | $ 421.60 | |||||||||||||
Net proceeds from sales of common stock | $ | $ 1,200,000 | $ 900,000 | ||||||||||||
Price per share (in dollars per share) | $ / shares | $ 9.68 | |||||||||||||
Underwriting Agreement | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Issuances of common stock, net (in shares) | 17,500 | |||||||||||||
Net proceeds | $ | $ 7,000,000 | |||||||||||||
Price per share (in dollars per share) | $ / shares | $ 20.40 | |||||||||||||
Underwriting Agreement | Maximum | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 8,348 | |||||||||||||
Underwriting Agreement | Pre-funded warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants sold | 404,075 | |||||||||||||
Price per share (in dollars per share) | $ / shares | $ 20 | |||||||||||||
Number of warrants exercised | 177,176 | |||||||||||||
Underwriting Agreement | Pre-funded warrants | Maximum | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 58,480 | |||||||||||||
Underwriting Agreement | Underwriter Warrants | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Commencement period for exercise of warrants, following the date of issuance | 180 days | |||||||||||||
Term of warrants | 5 years | |||||||||||||
Exercise price | $ / shares | $ 25.50 | |||||||||||||
Underwriting Agreement | Underwriter Warrants | Maximum | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Number of warrants purchased | 21,496 | |||||||||||||
Common Stock | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Maximum number of shares which the Company is authorized to issue | 290,000,000 | |||||||||||||
Issuances of common stock, net (in shares) | 611,226 | |||||||||||||
Preferred Stock | ||||||||||||||
Stockholders' Equity | ||||||||||||||
Maximum number of shares which the Company is authorized to issue | 10,000,000 |
Warrants (Details)
Warrants (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | Sep. 26, 2023 | Jun. 09, 2023 | Jun. 08, 2023 | Jun. 06, 2023 | Feb. 28, 2023 | Feb. 16, 2023 | |
Warrants | |||||||||
Number of warrants purchased | 391 | 249 | |||||||
Exercise price (in dollars per share) | $ 4,000 | ||||||||
Underwriter Initial public offering price (in percentage) | 125% | ||||||||
Term of warrants | 5 years | 5 years | |||||||
June Placement Agent Warrants | |||||||||
Warrants | |||||||||
Number of warrants purchased | 3,500 | 3,500 | |||||||
Exercise price (in dollars per share) | $ 175.20 | $ 175.20 | |||||||
Term of warrants | 3 years | ||||||||
February Placement Agent Warrants | |||||||||
Warrants | |||||||||
Number of warrants purchased | 249 | ||||||||
Exercise price (in dollars per share) | $ 527.20 | $ 527 | |||||||
Registered Direct Offering | |||||||||
Warrants | |||||||||
Number of warrants sold | 7,500 | ||||||||
private Placement Agent | |||||||||
Warrants | |||||||||
Exercise price (in dollars per share) | $ 12.10 | ||||||||
Pre-funded warrants | |||||||||
Warrants | |||||||||
Shares issued (in shares) | 50,000 | ||||||||
Price per share (in dollars per share) | $ 139.60 | ||||||||
Number of warrants sold | 21,496 | ||||||||
IPO Underwriter Warrants | |||||||||
Warrants | |||||||||
Number of warrants purchased | 391 | ||||||||
Exercise price (in dollars per share) | $ 4,000 | ||||||||
Term of warrants | 5 years | ||||||||
Underwriter Warrants | |||||||||
Warrants | |||||||||
Exercise price (in dollars per share) | $ 25.50 | ||||||||
Underwriter Warrants | Maximum | |||||||||
Warrants | |||||||||
Term of warrants | 5 years | ||||||||
Commencement period for exercise of warrants, following the date of issuance | 180 days | ||||||||
Series A warrants | |||||||||
Warrants | |||||||||
Exercise price (in dollars per share) | $ 130 | $ 130 | |||||||
Term of warrants | 3 years | 3 years | |||||||
Series A-1 Warrants | |||||||||
Warrants | |||||||||
Number of warrants purchased | 50,000 | 50,000 | |||||||
Exercise price (in dollars per share) | $ 130 | ||||||||
Consulting Agreement | |||||||||
Warrants | |||||||||
Number of warrants purchased | 156 | ||||||||
Sale of stock exercise price | $ 400 |
Warrants - Summary of Company's
Warrants - Summary of Company's Outstanding or Issuable Warrants (Details) - $ / shares | Dec. 31, 2023 | Jun. 30, 2023 | Jun. 08, 2023 | Feb. 28, 2023 | Feb. 16, 2023 |
Warrants | |||||
Number of warrants purchased | 391 | 249 | |||
Exercise price (in dollars per share) | $ 4,000 | ||||
IPO Underwriter Warrants | |||||
Warrants | |||||
Number of warrants purchased | 391 | ||||
Exercise price (in dollars per share) | $ 4,000 | ||||
February Placement Agent Warrants | |||||
Warrants | |||||
Number of warrants purchased | 249 | ||||
Exercise price (in dollars per share) | $ 527.20 | $ 527 | |||
Consultant warrants | |||||
Warrants | |||||
Number of warrants purchased | 156 | ||||
Exercise price (in dollars per share) | $ 400 | ||||
Series A-1 Warrants | |||||
Warrants | |||||
Number of warrants purchased | 50,000 | 50,000 | |||
Exercise price (in dollars per share) | $ 130 | ||||
Series A-2 Warrants | |||||
Warrants | |||||
Number of warrants purchased | 50,000 | ||||
Exercise price (in dollars per share) | $ 130 | ||||
June Placement Agent Warrants | |||||
Warrants | |||||
Number of warrants purchased | 3,500 | 3,500 | |||
Exercise price (in dollars per share) | $ 175.20 | $ 175.20 | |||
September Underwriter Warrants | |||||
Warrants | |||||
Number of warrants purchased | 21,496 | ||||
Exercise price (in dollars per share) | $ 25.50 | ||||
December Placement Agent Warrants | |||||
Warrants | |||||
Number of warrants purchased | 7,500 | ||||
Exercise price (in dollars per share) | $ 12.10 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - shares | 12 Months Ended | ||||||
Dec. 31, 2023 | Dec. 31, 2022 | Jan. 31, 2024 | Jan. 31, 2023 | Jan. 31, 2022 | Dec. 31, 2021 | Apr. 30, 2020 | |
Share-Based Compensation | |||||||
Significant shareholder threshold used for determining exercise price | 10% | ||||||
Exercise price as a percentage of fair value | 100% | ||||||
Exercise price as a percentage of fair value for shareholders owning specified minimum amount | 110% | ||||||
Option terms for shareholders owning specified minimum amount | 5 years | ||||||
Exercise of stock options (in shares) | 91 | ||||||
Number of shares terminated | 393 | ||||||
Number of stock options outstanding | 6,289 | 3,771 | 2,142 | ||||
Stock Option and Incentive Plan 2020 | |||||||
Share-Based Compensation | |||||||
Shares approved for issuance of options | 2,242 | ||||||
Terms of award | 10 | ||||||
Stock Option and Incentive Plan 2020 | Minimum | |||||||
Share-Based Compensation | |||||||
Vesting period | 2 years | ||||||
Stock Option and Incentive Plan 2020 | Maximum | |||||||
Share-Based Compensation | |||||||
Vesting period | 4 years | ||||||
Stock Option and Incentive Plan 2021 | |||||||
Share-Based Compensation | |||||||
Shares approved for issuance of options | 6,250 | ||||||
Options available for future grants | 1,569 | 811 | 807 | ||||
Number of stock options outstanding | 4,243 | ||||||
Employee Stock Option | Stock Option and Incentive Plan 2020 | |||||||
Share-Based Compensation | |||||||
Number of stock options outstanding | 2,050 | ||||||
Employee Stock Option | Stock Option and Incentive Plan 2021 | |||||||
Share-Based Compensation | |||||||
Options available for future grants | 3,469 |
Share-Based Compensation - Info
Share-Based Compensation - Information About Options to Purchase Common Stock (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of shares | |||
Outstanding, beginning balance | 3,771 | 2,142 | |
Granted | 2,911 | 1,720 | |
Exercised | (91) | ||
Forfeited | (393) | ||
Outstanding, ending balance | 6,289 | 3,771 | 2,142 |
Weighted average exercise price per share | |||
Outstanding, beginning balance | $ 592 | $ 264 | |
Granted | 226.88 | 976 | |
Exercised | 64 | ||
Forfeited | 459.02 | ||
Outstanding, ending balance | $ 419.58 | $ 592 | $ 264 |
Weighted average contractual term (years) | |||
Weighted average contractual term (years) | 3 years 8 months 12 days | 5 years 3 months 18 days | 5 years 2 months 12 days |
Granted | 10 months 24 days | 6 years 4 months 24 days | |
Intrinsic value of the outstanding options | $ 0 |
Share-Based Compensation - Gran
Share-Based Compensation - Grant-date Fair Value of Options Granted (Details) - Employee Stock Option - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (in years) | 6 years | |
Expected volatility | 93.20% | |
Weighted average grant date fair value of the options granted | $ 226.87 | $ 974.22 |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Risk-free interest rate | 4.01% | 1.38% |
Expected term (in years) | 3 years 6 months | |
Expected volatility | 100.60% | |
Fair value per share of underlying stock | $ 226.80 | $ 408 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Risk-free interest rate | 4.72% | 4.12% |
Expected term (in years) | 10 years | |
Expected volatility | 100.80% | |
Fair value per share of underlying stock | $ 238.80 | $ 1,960 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Stock Option | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 1,013,527 | $ 395,329 |
Period for recognition of stock-based compensation expense | 2 years 3 months 18 days | |
Restricted Stock | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 183,765 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - Stock Option and Incentive Plan 2020 | 12 Months Ended |
Dec. 31, 2023 | |
Minimum | |
Share-Based Compensation | |
Vesting period | 2 years |
Maximum [Member] | |
Share-Based Compensation | |
Vesting period | 4 years |
Employee Stock Purchase Plan (D
Employee Stock Purchase Plan (Details) - shares | 12 Months Ended | |||
Dec. 31, 2021 | Jan. 31, 2024 | Jan. 31, 2023 | Jan. 31, 2022 | |
Employee Stock Purchase Plan | ||||
Shares issued on ESPP | 188 | |||
Shares available in ESPP | 113 | 113 | ||
Subsequent Events | ||||
Employee Stock Purchase Plan | ||||
Shares available in ESPP | 113 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of basic and diluted loss per share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator | ||
Net loss | $ (18,546,095) | $ (17,564,968) |
Denominator | ||
Weighted-average common shares outstanding, Basic | 179,006 | 16,222 |
Weighted-average common shares outstanding, Diluted | 179,006 | 16,222 |
Net loss per share, Basic | $ (103.61) | $ (1,082.79) |
Net loss per share, Diluted | $ (103.61) | $ (1,082.79) |
Income Taxes - Effective income
Income Taxes - Effective income tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Federal income tax benefit at statutory rate | 21% | 21% |
State and local tax, net of federal benefit | 6% | 6.30% |
Permanent differences | 1.50% | (0.10%) |
Research and development credit | 2.20% | 2.40% |
Share-based compensation | (1.00%) | (0.40%) |
Change in valuation allowance | (29.70%) | (29.20%) |
Effective income tax rate | 0% | 0% |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 5,880,202 | $ 3,434,543 |
Capitalized research and development | 5,499,242 | 3,166,280 |
Capitalized patent and other costs | 3,071 | 5,219 |
Stock-based compensation | 118,733 | 69,592 |
Accrued expenses | 14,125 | 24,521 |
Fixed assets | 11,027 | 1,889 |
Research and development tax credit carryforwards | 1,136,299 | 454,616 |
Subtotal deferred tax assets before valuation allowance | 12,662,699 | 7,156,660 |
Less valuation allowance | $ (12,662,699) | $ (7,156,660) |
Income Taxes - Unrecognized tax
Income Taxes - Unrecognized tax assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Balance | $ 0 | $ 0 |
Increase for tax positions of prior years | 228 | 0 |
Increase based on tax positions related to current year | 125 | 0 |
Balance | $ 353 | $ 0 |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) | 12 Months Ended | |||
Nov. 07, 2023 item | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax expense (benefit) | $ 0 | $ 0 | ||
Accrued interest or penalties related to uncertain tax positions | 0 | 0 | ||
Interest or penalties related to uncertain tax positions recognized in the Company's statements of operations | 0 | 0 | ||
change in valuation allowance | 5,506,039 | 5,136,825 | ||
Unrecognized tax benefits | $ 353,000 | 0 | $ 0 | |
Tax credit carryforward expiration term | 3 years | |||
Payroll tax prepayments recorded under act | $ 250,000 | 250,000 | ||
Maximum [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Number of days minimum Bid Price | item | 20 | |||
Minimum | ||||
Operating Loss Carryforwards [Line Items] | ||||
Number of days minimum Bid Price | item | 10 | |||
Internal revenue | ||||
Operating Loss Carryforwards [Line Items] | ||||
Ownership interest | 50% | |||
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 21,556,006 | 12,277,816 | ||
Percentage of limitation of usage of operating losses | 80% | |||
Federal | Federal research and development | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforward | $ 864,408 | 549,780 | ||
Federal | 2017 and Prior Years | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 38,297 | |||
State and Local | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 21,415,201 | 12,137,011 | ||
State and Local | Federal research and development | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforward | 758,417 | $ 495,079 | ||
State and Local | Tax Year 2036 | Federal research and development | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforward | $ 7,013 |
Subsequent Events (Details)
Subsequent Events (Details) | 1 Months Ended | 12 Months Ended | |||||
Jan. 18, 2024 USD ($) $ / shares shares | Jan. 16, 2024 item $ / shares | Nov. 07, 2023 item $ / shares | Jun. 06, 2023 $ / shares shares | Sep. 30, 2023 shares | Dec. 31, 2023 USD ($) $ / shares shares | Feb. 28, 2023 shares | |
Subsequent Events | |||||||
Reverse stock split ratio | 0.05 | ||||||
Exercise price | $ 4,000 | ||||||
Term of warrants | 5 years | 5 years | |||||
Number of warrants purchased | shares | 391 | 249 | |||||
Closing bid price | $ 1 | ||||||
Initial Period | item | 180 | ||||||
Net proceeds from sales of common stock | $ | $ 15,909,324 | ||||||
Maximum | |||||||
Subsequent Events | |||||||
Number of days minimum Bid Price | item | 20 | ||||||
Pre-funded warrants | |||||||
Subsequent Events | |||||||
Number of warrants sold | shares | 21,496 | ||||||
Price per share (in dollars per share) | $ 139.60 | ||||||
Securities Purchase Agreement | |||||||
Subsequent Events | |||||||
Price per share (in dollars per share) | $ 140 | ||||||
Securities Purchase Agreement | Pre-funded warrants | |||||||
Subsequent Events | |||||||
Number of warrants sold | shares | 47,525 | ||||||
Subsequent Events | |||||||
Subsequent Events | |||||||
Reverse stock split ratio | 0.025 | ||||||
Number of days minimum bid price not maintained | item | 10 | ||||||
Minimum bid price | $ 1 | ||||||
Subsequent Events | Securities Purchase Agreement | |||||||
Subsequent Events | |||||||
Number of warrants sold | shares | 11,885,246 | ||||||
Price per share (in dollars per share) | $ 1.22 | ||||||
Subsequent Events | Registered Direct Offering | |||||||
Subsequent Events | |||||||
Aggregate of direct offering | shares | 428,924 | ||||||
Net proceeds from sales of common stock | $ | $ 6,200,000 | ||||||
Subsequent Events | Registered Direct Offering | Pre-funded warrants | |||||||
Subsequent Events | |||||||
Number of warrants sold | shares | 5,513,699 | ||||||
Price per share (in dollars per share) | $ 1.21 | ||||||
Subsequent Events | Registered Direct Offering | January Warrants | |||||||
Subsequent Events | |||||||
Purchase of common stock | shares | 1 | ||||||
Exercise price | $ 1.22 | ||||||
Term of warrants | 3 years 6 months | ||||||
Subsequent Events | Placement Agent | Registered Direct Offering | January Placement Agent Warrants | |||||||
Subsequent Events | |||||||
Exercise price | $ 1.525 | ||||||
Term of warrants | 3 years 6 months | ||||||
Subsequent Events | Placement Agent | Registered Direct Offering | January Placement Agent Warrants | Maximum | |||||||
Subsequent Events | |||||||
Number of warrants purchased | shares | 356,557 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (18,546,095) | $ (17,564,968) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |