Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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, $0.0001 par value per share | |
Trading Symbol | RNAZ | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 6,622,053 | |
Entity Central Index Key | 0001829635 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash | $ 4,913,676 | $ 2,767,598 |
Prepaid expenses and other current assets | 1,800,346 | 1,687,846 |
Total current assets | 6,714,022 | 4,455,444 |
Property and equipment, net of depreciation | 92,379 | 120,707 |
Right-of-use asset, net of amortization | 372,210 | 481,694 |
Security deposit | 111,856 | 111,856 |
Total assets | 7,290,467 | 5,169,701 |
Current liabilities: | ||
Accounts payable and accrued expenses | 2,366,764 | 3,051,259 |
Deferred grant income | 0 | 27,057 |
Short-term lease liability | 339,408 | 412,280 |
Total current liabilities | 2,706,172 | 3,490,596 |
Long-term lease liability | 38,291 | |
Total liabilities | 2,706,172 | 3,528,887 |
Stockholders' equity: | ||
Preferred stock - $0.0001 par value; 10,000,000 shares authorized at March 31, 2024, and December 31, 2023; -0- shares issued and outstanding at March 31, 2024 and December 31, 2023 | ||
Common stock - $0.0001 par value, 290,000,000 shares authorized at March 31, 2024, and December 31, 2023; 5,808,053 and 627,448 shares issued and outstanding at March 31, 2024, and December 31, 2023, respectively | 581 | 63 |
Additional paid-in capital | 54,326,870 | 48,057,095 |
Accumulated deficit | (49,743,156) | (46,416,344) |
Total stockholders' equity | 4,584,295 | 1,640,814 |
Total liabilities and stockholders' equity | $ 7,290,467 | $ 5,169,701 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 5,808,053 | 627,448 |
Common stock, share outstanding | 5,808,053 | 627,448 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses | ||
Research and development | $ 1,759,020 | $ 2,591,350 |
General and administrative | 1,529,962 | 2,296,334 |
Total operating expenses | 3,288,982 | 4,887,684 |
Operating loss | (3,288,982) | (4,887,684) |
Other income (expense) | ||
Grant income | 27,057 | 79,409 |
Currency exchange gain/(loss) | (55,349) | |
Interest income | 168 | 4,770 |
Interest expense | (9,706) | (13,429) |
Total other income (expense) | (37,830) | 70,750 |
Net loss | $ (3,326,812) | $ (4,816,934) |
Weighted-average common shares outstanding, Basic | 5,142,398 | 18,593 |
Weighted-average common shares outstanding, Diluted | 5,142,398 | 18,593 |
Net loss per share, Basic | $ (0.65) | $ (259.07) |
Net loss per share, Diluted | $ (0.65) | $ (259.07) |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance, beginning of period at Dec. 31, 2022 | $ 2 | $ 31,110,943 | $ (27,870,249) | $ 3,240,696 |
Balance, beginning of period (in shares) at Dec. 31, 2022 | 16,222 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Net loss | (4,816,934) | (4,816,934) | ||
Issuances of common stock, net | 1,180,686 | 1,180,686 | ||
Issuances of common stock, net (in shares) | 3,558 | |||
Share based compensation | 158,760 | 158,760 | ||
Balance, end of period at Mar. 31, 2023 | $ 2 | 32,450,389 | (32,687,183) | (236,792) |
Balance, end of period (in shares) at Mar. 31, 2023 | 19,780 | |||
Balance, beginning of period at Dec. 31, 2023 | $ 63 | 48,057,095 | (46,416,344) | 1,640,814 |
Balance, beginning of period (in shares) at Dec. 31, 2023 | 627,448 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Net loss | (3,326,812) | (3,326,812) | ||
Issuances of common stock, net | $ 518 | 6,086,623 | 6,087,141 | |
Issuances of common stock, net (in shares) | 5,180,605 | |||
Share based compensation | 183,152 | 183,152 | ||
Balance, end of period at Mar. 31, 2024 | $ 581 | $ 54,326,870 | $ (49,743,156) | $ 4,584,295 |
Balance, end of period (in shares) at Mar. 31, 2024 | 5,808,053 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (3,326,812) | $ (4,816,934) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 32,164 | 29,640 |
Amortization of right-of-use asset | 109,483 | 70,559 |
Share-based compensation expense | 183,152 | 158,760 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (112,500) | (673,207) |
Accounts payable and accrued expenses | (684,493) | 575,982 |
Deferred grant income | (27,057) | |
Grants receivable | 360,229 | |
Security deposit | (111,856) | |
Operating lease liability | (111,164) | (106,724) |
Net cash used in operating activities | (3,937,227) | (4,513,551) |
Cash flows from investing activities: | ||
Purchase of equipment | (3,836) | (12,896) |
Net cash used in investing activities | (3,836) | (12,896) |
Cash flows from financing activities: | ||
Net proceeds from sales of common stock | 6,087,141 | 1,180,686 |
Net cash provided by financing activities | 6,087,141 | 1,180,686 |
Net change in cash | 2,146,078 | (3,345,761) |
Cash, beginning of period | 2,767,598 | 4,968,418 |
Cash, end of period | 4,913,676 | 1,622,657 |
Cash paid during the period for: | ||
Interest related to insurance premium payment plan | $ 5,653 | 8,298 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 874,957 | |
Deferred offering costs included in accounts payable and accrued expenses | $ 135,797 |
Nature of Business and Liquidit
Nature of Business and Liquidity | 3 Months Ended |
Mar. 31, 2024 | |
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 $28.75 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 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 three months ended March 31, 2024, net cash used in operating activities was approximately $3.9 million and the Company’s net loss was approximately $3.3 million. As of March 31, 2024, the Company had an accumulated deficit of approximately $49.7 million and approximately $4.9 million in cash. The Company plans to expand development of its lead therapeutic candidate and other candidates, and explore strategic partnerships. Management believes that current cash is sufficient to fund operations and capital requirements into the third 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 these financial statements. To support its planned expanded 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 March 31, 2024, the Company’s primary source of capital was from the sale of equity securities in the IPO and subsequent financings, previous sales of convertible promissory notes and funds received under 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 consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating development programs, and the Company may need to seek an in-court or out-of-court restructuring of its liabilities. In the event of such future restructuring activities, holders of the Company’s common stock and other securities will likely suffer a total loss of their investment. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies (a) Basis of Presentation The interim financial statements included herein are unaudited. These financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, these financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair presentation of the financial position of the Company at March 31, 2024, its results of operations for the three months ended March 31, 2024 and 2023, and its cash flows for the three months ended March 31, 2024 and 2023. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2023, and notes thereto contained in the Company’s Annual Report on Form 10-K, filed with the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements. (b) Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant items subject to such estimates and assumptions include but are not limited to the valuation of share-based compensation, income from grants, and accrued research and development costs. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. (c) Basic and Diluted Loss per Share Basic net loss per share is determined by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share includes the effect, if any, from the potential conversion, vesting or exercise of securities (“Contingent Securities”) such as convertible promissory notes, stock options and warrants which would result in the issuance of additional shares of common stock. The computation of diluted net loss per shares does not include the conversion or exercise of Contingent Securities when the effect of doing so would be antidilutive. (d) Cash The Company classifies deposits in banks, money market funds and cash invested temporarily in various instruments with original maturities of three months or less as cash and cash equivalents. 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 March 31, 2024, and December 31, 2023, included cash, grant receivable, prepaid expenses and other current assets, right-of-use asset, accounts payable and accrued expenses, deferred grant income, and current and long-term portion of lease liability. Cash is reported at fair value. The recorded carrying amount 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 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. (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. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies share-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Forfeitures are accounted for as they occur. The estimated fair value of the common stock used by the Company to determine the expense of option awards is the closing Nasdaq price of the Company’s common shares on the date of each award. Other factors used in calculating the fair value of share-based awards represented management’s best estimates, some of which involve inherent uncertainties and the application of management’s judgment. As a result, if factors were to change and management were to use different assumptions, share-based compensation expense could be materially different. Certain stock appraisal methodologies utilize, among other variables, the volatility of the stock price. When private, the Company lacked Company-specific historical and implied volatility information for its stock. Therefore, it estimated its expected stock price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time, if ever, as it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected life of options awarded was estimated using the simplified method because the Company has limited historical information on which to base reasonable expectations about future exercise patterns and post-vesting employment. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on its common stock and does not expect to pay cash dividends in the foreseeable future. (i) Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Laboratory equipment 3 years Furniture and fixtures 5 years Computer and office equipment 3 years Leasehold improvements Shorter of the useful life or remaining lease term When assets are retired or otherwise disposed of, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the statements of operations in the period of disposal. Expenditures for repairs and maintenance are charged to expense as incurred. (j) Income Taxes The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of the dates of the Company’s balance sheets herein, the Company had a full valuation allowance against deferred tax assets. The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (“ASC 740”). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are currently no open federal or state tax audits. The Company has not recorded any liability for uncertain tax positions at the dates of the Company’s balance sheets herein. (k) Emerging Growth Company Status The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act (“JOBS Act”) and may take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of a public offering or such earlier time that it is no longer an EGC. (l) Reverse Stock Split 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 share for every 40 shares previously held with no change in the par value per share. The 2024 Reverse Split did not change the number of authorized shares of common stock. All common stock share and per share data, and exercise price data for applicable common stock equivalents, included in these financial statements have been retroactively adjusted to reflect the 2024 Reverse Split. (m) Collaboration Agreements When the Company enters into a collaboration agreement, it evaluates the arrangement against the requirements of ASC 808, “Collaborative Arrangements,” as well as ASU 2018-18 which clarifies the interaction between Topic 808 and Topic 606. ASU 2018-18 indicates that collaborative arrangements could be partially in the scope of other guidance, including ASC 606. (n) Leases The Company leases certain office and laboratory space. At inception, the Company determines if a contract or arrangement contains a lease. Leases are evaluated and classified as either operating or finance leases. A lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. A lease that does not meet any of the criteria to be classified as a finance lease is classified as an operating lease. Operating leases are included on the balance sheets as right-of-use (“ROU”) assets, net; current portion of operating lease liabilities; and operating lease liabilities. ROU assets and operating lease liabilities are recognized based on the present value of the future lease payments over the lease term at the commencement date. Where leases do not provide an implicit rate for use in determining the present value of future payments, the Company uses an incremental borrowing rate that represents the cost of borrowing on a collateralized basis for a period equal to the expected lease term. ROU assets also include any lease payments made and exclude any lease incentives and initial direct costs incurred. Lease terms may include periods under options to extend the lease or terminate the lease prior to expiration when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term, including rent abatement periods and rent holidays. While lease liabilities are not remeasured as a result of changes to these costs, changes are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred. Finance leases are included on the balance sheets as property and equipment, net; current maturities of long-term debt; and long-term debt. Finance lease costs are split between depreciation expense related to the asset and interest expense on the lease liability, using the effective rate charged by the lessor. The Company has elected to account for lease and non-lease components separately. Additionally, the Company has elected not to record short-term leases, those with expected terms of twelve months or less, on the balance sheets. Certain lease agreements include fixed escalations, while others include rental payments adjusted periodically for inflation. (o) Warrant Accounting The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, “Distinguishing Liabilities from Equity” (“ASC 480”), and ASC 815, “Derivatives and Hedging” (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares and whether warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end-date while the warrants are outstanding. For issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component of equity at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as liabilities at their initial fair value on the date of issuance, and 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 and in the three months ended March 31, 2024, meet the criteria for equity classification under ASC 815, those warrants were classified as equity as of March 31, 2024, and December 31, 2023. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | (3) 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 | 3 Months Ended |
Mar. 31, 2024 | |
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: March 31, December 31, 2024 2023 Prepaid operating expenses $ 97,324 $ 116,607 Contract manufacturers and research organizations 1,061,170 717,686 Insurance premiums 219,360 431,061 Prepaid FICA 422,492 422,492 $ 1,800,346 $ 1,687,846 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2024 | |
Property and Equipment | |
Property and Equipment | (5) Property and Equipment Property and equipment, net consisted of the following: March 31, December 31, 2024 2023 Laboratory and computer equipment $ 387,886 $ 384,050 Less accumulated depreciation (295,507) (263,343) Total property and equipment, net $ 92,379 $ 120,707 Depreciation expense for the three months ended March 31, 2024 and 2023, was $32,164 and $29,640, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
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: March 31, December 31, 2024 2023 Professional and general consulting fees $ 667,538 $ 375,550 R&D-related – CMOs, CROs, supplies, equipment and consulting 919,816 1,260,578 General expenses 139,845 295,508 Insurance premiums 128,149 400,236 Payroll and benefits 202,361 589,404 Accrued license payments 309,055 129,983 $ 2,366,764 $ 3,051,259 At March 31, 2024, and December 31, 2023, the Company’s outstanding payables to CROs or CMOs included above were $634,512 and $1,020,875, respectively. See Note 8 for further information regarding the accrued license payments. |
Grant Income
Grant Income | 3 Months Ended |
Mar. 31, 2024 | |
Grant Income | |
Grant Income | (7) 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 $27,057 and $79,409 for the three months ended March 31, 2024 and 2023, respectively. The Company recorded grant income receivable of $0 at both March 31, 2024, and December 31, 2023. The Company had deferred grant income of $0 and $27,057 at March 31, 2024, and December 31, 2023, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
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 three months ended March 31, 2024. Prior to February 1, 2023, the Company had no operating leases with maturities greater than one year. The Company does not recognize any variable lease costs or short-term lease costs in connection with the operating lease. Three Months Ended Operating Leases March 31, 2024 Weighted average remaining lease term (years) 0.8 Weighted average discount rate 3.6 % Year ending December 31, 2024 $ 307,246 2025 38,291 Total undiscounted lease payments 345,537 Imputed interest (6,129) Lease liability $ 339,408 Rent expense for the three months ended March 31, 2024 and 2023, was $109,483 and $126,944, respectively. (b) License Agreements In November 2018, the Company licensed the exclusive rights to certain intellectual property to support development of its therapeutic candidates (“License”). The intellectual property licensed by the Company is owned by The General Hospital Corporation, d/b/a Massachusetts General Hospital, (“Licensor”). Payments by the Company under the license agreement included a one-time non-refundable fee of $50,000 paid after execution of the License; reimbursement of Licensor’s patent costs which, at execution of the License, were approximately $145,000; a minimum annual license fee of $25,000 payable within 60 days of each anniversary of the effective date of the License prior to the first commercial sale of a product or process covered by the License; milestone payments upon attainment of certain milestone events; royalties based on net sales of products covered by the patent-related rights; and a portion of any sublicense income received by the Company. The Company is responsible for the development and commercialization of the licensed assets and for meeting certain milestones set forth in the License. The milestone payments the Company shall pay to Licensor shall not exceed $1,550,000 based upon and subject to the attainment of each milestone event indicated below. These payments are generally due within 60 days of achievement of the milestone. Milestone Event Amount Enrollment of first patient in a phase II clinical trial of a therapeutic product or process $ 100,000 Enrollment of first patient in a phase III clinical trial of a therapeutic product or process $ 200,000 First commercial sale of a therapeutic product or process $ 1,000,000 Filing of an application for regulatory approval of a clinical diagnostic product or process $ 100,000 First regulatory approval of a clinical diagnostic product or process $ 150,000 As of March 31, 2024, and December 31, 2023, no milestone events had been achieved. The royalties to be paid to Licensor shall be assessed on net sales of licensed products on a country-by-country basis in an amount equal to 3.0% for therapeutic products or processes, and 6.0% for clinical diagnostic products and processes. The Company shall pay Licensor 30% of any and all sublicense income. The Company has the right to terminate the License at any time by giving 90 days’ advance notice subject to the payment of any amounts due under the License at that time. The License may also be terminated for cause by either party upon the breach of the material obligations of the other party or the bankruptcy or liquidation of the other party. If the Company does not terminate the License, the term of the License shall continue until the latest of (i) the date on which all issued patents and filed patent applications subject to the License have expired or been abandoned; (ii) expiration of the last to expire regulatory exclusivity covering a covered product or process; or (iii) 10 years after the first commercial sale. The License requires the Company to make royalty payments beyond the term of the License at 1.5%. In November 2020, the Company and Licensor amended the November 2018 license. Under the amendment, the intellectual property licensed in 2018 was categorized as “Patent Family 1” and a provisional patent filing related to the Company’s nanoparticle technology was added to Patent Family 1. A second patent family (“Patent Family 2”) was created which includes Licensor intellectual property targeting PD-L1. The minimum annual license fee prior to the first commercial sale of a product or process covered by the License was increased from $25,000 per year to $30,000 per year for Patent Family 1 and a minimum annual license fee of $10,000 per year was added related to Patent Family 2. All other terms of the License including milestone payments, royalties and payment terms related to sublicense income received by the Company remain the same as in the original License. Accrued License Obligations At March 31, 2024, and December 31, 2023, the Company had accrued $309,055 and $129,983, respectively, in license payments under the foregoing arrangements included in accounts payable and accrued expenses. (c) Collaboration Agreement On July 29, 2022, the Company signed 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 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 Prior to the IPO, the Company entered into employment agreements with its executive officers which became effective on completion of the IPO. The employment agreements provide the employee with, among other things, severance payments upon termination of the agreement by the Company for any reason other than for cause, death or disability or by the employee for good reason. The maximum aggregate severance payments under the agreements, which arise in the event of termination involving a Change of Control (as defined in the agreements), are approximately $1,031,400. (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 March 31, 2024, and December 31, 2023, the Company did not know of any claims or actions pending against it or threatened, the ultimate disposition of which could have a material adverse effect on its results of operations or financial condition except a claim by an investment bank that it is entitled to fees, a claim which the Company rigorously disputes. (f) Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors 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 March 31, 2024, and December 31, 2023. (g) Risks and Uncertainties As geopolitical events such as wars in the Ukraine and the Middle East and major health issues such as SARS-CoV-2, or the coronavirus, continue to evolve, the extent to which they affect the Company’s operations directly or through parties on whom the Company depends is highly uncertain and cannot be predicted with confidence. The outcomes resulting from these or other 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 | 3 Months Ended |
Mar. 31, 2024 | |
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, on May 22, 2023, to effect a reverse split (the 2023 Reverse Split), and on January 16, 2024, to effect the 2024 Reverse Split. The total number of shares which the Company is authorized to issue is 300,000,000, each with a par value of $0.0001 per share. Of these shares, 290,000,000 shall be common stock and 10,000,000 shall be preferred stock. At March 31, 2024, and December 31, 2023, the Company had 5,808,053 and 627,448 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 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 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 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 White Lion expenses but before aggregate legal and printing expenses the Company incurred of $75,418. The commitment period ended May 31, 2023. On June 6, 2023, the Company entered into a Securities Purchase Agreement with a purchaser named therein pursuant to which the Company sold 2,475 shares of common stock, 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 $0.40 per share. All the PFWs sold in the June RDO were exercised prior to March 31, 2024. See Note 10. In connection with the June RDO, the Company also issued the placement agent warrants to purchase up to 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 with ThinkEquity LLC, as underwriter, pursuant to which it issued and sold 17,500 shares of common stock and 404,075 PFWs, including the partial exercise of the underwriter’s over-allotment 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 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 March 31, 2024, all September Offering PFWs had been exercised. Net proceeds from the September Offering, after deducting underwriting discounts, commissions and fees paid to the underwriter and other offering expenses, were approximately $6.7 million. In connection with the September Offering, the Company also issued warrants to the underwriter to purchase up to 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 closed an offering under a Securities Purchase Agreement with certain 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 the placement agent warrants 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. On January 22, 2024, the Company closed an offering under a Securities Purchase Agreement with certain purchasers named therein pursuant to which the Company sold three and one-half years of the PFWs sold in the January 2024 RDO were exercised prior to March 31, 2024. In connection with the January 2024 RDO, the Company also issued the placement agent warrants to purchase up to three and one-half years (b) Common Stock i. Dividends Subject to the rights of holders of any preferred stock, holders of common stock are entitled to receive dividends as may be declared from time to time by the Board. No cash dividends were declared or paid during the three months ended March 31, 2024, nor at any other time through the date of these financial statements. ii. Liquidation Subject to the rights of holders of any preferred stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the remaining assets of the Company will be distributed to holders of common stock. iii. Voting Holders of common stock are entitled 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 | 3 Months Ended |
Mar. 31, 2024 | |
Warrants | |
Warrants | (10) Warrants In connection with the IPO, the Company granted the underwriters warrants (the “IPO Underwriter Warrants”) to purchase up to 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 term and were not exercisable prior to January 9, 2022. All of the IPO Underwriter Warrants were outstanding at March 31, 2024. The Company accounts for these warrants as a component of stockholders’ equity. In connection with the February RDO, the Company issued the February Placement Agent Warrants to purchase up to 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 $527.00 per share. The Company accounts for these warrants as a component of stockholders’ equity. 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. These Consultant Warrants became exercisable any time after August 23, 2023, until February 23, 2028. The Company accounts for these warrants as a component of stockholders’ equity. In connection with the June RDO, the Company issued 47,525 PFWs, together with 50,000 Series A-1 Warrants and 50,000 Series A-2 Warrants, at a purchase price of $139.60 per PFW. All of these PFWs were exercised prior to the date of these financial statements at $0.40 per share. The Series A-1 Warrants and Series A-2 Warrants became exercisable commencing June 9, 2023, 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 placement agent to purchase up to 3,500 shares of common stock. The June Placement Agent Warrants became exercisable commencing June 9, 2023, expire three years after issuance, and have an exercise price per share of $175.00 per share. The Company accounts for these warrants as a component of stockholders’ equity. In connection with the September Offering, the Company issued 404,075 PFWs, at a purchase price of $20.00 per PFW. Each of these PFWs was exercisable at $0.40 per share. All the September Offering PFWs were exercised prior to the date of these financial statements. The Company also issued warrants to the underwriter to purchase up to 21,079 shares of common stock. The September 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. On October 5, 2023, the underwriter partially exercised its overallotment option to purchase an additional 8,348 shares of common stock. As a result of the partial overallotment exercise, the Company also issued an additional 417 September Underwriter Warrants to the underwriter. The Company accounts for these warrants as a component of stockholders’ equity. The December Placement Agent Warrants became exercisable on issuance, expire five years after issuance, and have an exercise price per share of $12.10 per share. The Company accounts for these warrants as a component of stockholders’ equity. In connection with the January 2024 RDO, the Company issued 11,885,246 January 2024 Warrants, 5,513,699 PFWs with no expiration date and exercisable at $0.01 per share, and 356,558 January 2024 Placement Agent Warrants. The January 2024 Warrants became exercisable commencing on issuance and are exercisable for three and one-half years three and one-half years The following table summarizes the Company’s outstanding or issuable warrants at March 31, 2024: Number Exercise Price Description of Shares Per Share IPO Underwriter Warrants 391 $ 4,000 February Placement Agent Warrants 249 527 Consultant Warrants 156 400 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 January 2024 Common Stock Purchase Warrants 11,885,246 1.22 January 2024 Placement Agent Warrants 356,557 1.525 |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
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 3,791 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 shares in January 2023, and 31,372 shares 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 for grants to any person possessing more than 10% of the total combined voting power of all classes of stock). Of options awarded under the 2021 Plan, 3,905 were outstanding at March 31, 2024. At March 31, 2024, there were 1,930 options outstanding under the 2020 Plan that were vested and exercisable and 3,486 options outstanding under the 2021 Plan that were vested and exercisable. Information about options to purchase common stock of the Company under both Plans is as follows: Weighted average Weighted exercise average Number of price contractual shares per share term (years) Outstanding at December 31, 2022 3,771 $ 592.00 5.3 Granted 2,911 226.88 6.4 Exercised — — — Forfeited (393) 459.02 — Outstanding at December 31, 2023 6,289 419.58 3.7 Granted — — — Exercised — — — Forfeited (414) 819.52 — Outstanding at March 31, 2024 5,875 $ 407.11 3.9 The intrinsic value of the outstanding options as of March 31, 2024, was $0. Option Valuation No options were granted in the three months ended March 31, 2024. The assumptions that the Company used to determine the grant-date fair value of options granted in the year ended December 31, 2023, were as follows: Year ended December 31, 2023 Risk-free interest rate 4.01% - 4.72% Expected term (in years) 6.0 Expected volatility 100.6% - 100.8% Expected dividend yield — Fair value per share of underlying stock $226.80 - $238.80 The Company recorded share-based compensation expense of $183,152 and $158,760 during the three months ended March 31, 2024 and 2023, respectively. Share-based compensation in both periods was entirely related to stock options. The remaining share-based compensation expense to be recognized in the future is $109,119 over approximately 2.2 years. |
Employee Stock Purchase Plan
Employee Stock Purchase Plan | 3 Months Ended |
Mar. 31, 2024 | |
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 increases by approximately 113 shares in January of each year beginning in 2022. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Net Loss per Share | (13) Net Loss per Share The Company reported net losses for the three months ended March 31, 2024 and 2023. Reported basic and diluted net loss per share attributable to common stockholders are the same for each period because shares issuable in connection with Contingent Securities have been excluded from the computation of diluted weighted-average shares outstanding. The effect of their inclusion would have been antidilutive. In accordance with ASC 260-10-45-13, a pre-funded, or penny, warrant is an instrument that requires the holder to pay little or no consideration to receive the shares upon exercise of the warrant. Since the shares underlying the PFWs are issuable for little or no consideration, the Company considered them outstanding in the context of basic earnings per share. The following table sets forth the computation of basic and diluted loss per share: Three months ended March 31, 2024 2023 Basic and diluted loss per share Net loss $ (3,326,812) $ (4,816,934) Weighted-average common shares outstanding 5,142,398 18,593 Net loss per share $ (0.65) $ (259.07) |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | (14) Income Taxes The Company’s income tax benefit (expense) was $0 for the three months ended March 31, 2024 and 2023. The Company has recorded a full valuation allowance against its net deferred tax assets as of March 31, 2024, and December 31, 2023, because the Company has determined that is it more likely than not that these assets will not be fully realized due to historic net operating losses incurred. Accordingly, the benefit of the net operating loss that would have been recognized in the three months ended March 31, 2024 and 2023, was fully offset by changes in the valuation allowance. As of March 31, 2024, and December 31, 2023, 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. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events | |
Subsequent Events | (15) Subsequent Events For its financial statements as of March 31, 2024, the Company evaluated subsequent events through May 15, 2024, the date on which those financial statements were issued, and determined that there were none for which recognition or disclosure is warranted except: On May 7, 2024, the Company reported that it had received a letter from the Nasdaq Stock Market (“Nasdaq”) Staff notifying the Company that it had not regained compliance with Nasdaq Listing Rule 5550(a)(2), requiring that a company maintain a minimum closing bid price of $1.00 per share (the “Minimum Bid Price Requirement”) during the time period Nasdaq provided for the Company to do so. As a result, the shares of the Company’s common stock are subject to delisting from The Nasdaq Capital Market. The Company subsequently filed a request for a hearing before a Nasdaq Hearings Panel (the “Panel”) at which time the Company intends to appeal the Staff’s determination. The hearing has been scheduled for June 25, 2024. There is no assurance as to the outcome of the planned appeal. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | (a) Basis of Presentation The interim financial statements included herein are unaudited. These financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, these financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair presentation of the financial position of the Company at March 31, 2024, its results of operations for the three months ended March 31, 2024 and 2023, and its cash flows for the three months ended March 31, 2024 and 2023. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2023, and notes thereto contained in the Company’s Annual Report on Form 10-K, filed with the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements. |
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 and cash equivalents. 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 March 31, 2024, and December 31, 2023, included cash, grant receivable, prepaid expenses and other current assets, right-of-use asset, accounts payable and accrued expenses, deferred grant income, and current and long-term portion of lease liability. Cash is reported at fair value. The recorded carrying amount 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 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. 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. |
Reverse Stock Split | (l) Reverse Stock Split 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 share for every 40 shares previously held with no change in the par value per share. The 2024 Reverse Split did not change the number of authorized shares of common stock. All common stock share and per share data, and exercise price data for applicable common stock equivalents, included in these financial statements have been retroactively adjusted to reflect the 2024 Reverse Split. |
Collaboration Agreements | (m) Collaboration Agreements When the Company enters into a collaboration agreement, it evaluates the arrangement against the requirements of ASC 808, “Collaborative Arrangements,” as well as ASU 2018-18 which clarifies the interaction between Topic 808 and Topic 606. ASU 2018-18 indicates that collaborative arrangements could be partially in the scope of other guidance, including ASC 606. |
Leases | (n) 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 | (o) Warrant Accounting The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, “Distinguishing Liabilities from Equity” (“ASC 480”), and ASC 815, “Derivatives and Hedging” (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares and whether warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end-date while the warrants are outstanding. For issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component of equity at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as liabilities at their initial fair value on the date of issuance, and 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 and in the three months ended March 31, 2024, meet the criteria for equity classification under ASC 815, those warrants were classified as equity as of March 31, 2024, and December 31, 2023. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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) | 3 Months Ended |
Mar. 31, 2024 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | March 31, December 31, 2024 2023 Prepaid operating expenses $ 97,324 $ 116,607 Contract manufacturers and research organizations 1,061,170 717,686 Insurance premiums 219,360 431,061 Prepaid FICA 422,492 422,492 $ 1,800,346 $ 1,687,846 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property and Equipment | |
Schedule of property and equipment | March 31, December 31, 2024 2023 Laboratory and computer equipment $ 387,886 $ 384,050 Less accumulated depreciation (295,507) (263,343) Total property and equipment, net $ 92,379 $ 120,707 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | March 31, December 31, 2024 2023 Professional and general consulting fees $ 667,538 $ 375,550 R&D-related – CMOs, CROs, supplies, equipment and consulting 919,816 1,260,578 General expenses 139,845 295,508 Insurance premiums 128,149 400,236 Payroll and benefits 202,361 589,404 Accrued license payments 309,055 129,983 $ 2,366,764 $ 3,051,259 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies | |
Schedule of lease cost | Three Months Ended Operating Leases March 31, 2024 Weighted average remaining lease term (years) 0.8 Weighted average discount rate 3.6 % Year ending December 31, 2024 $ 307,246 2025 38,291 Total undiscounted lease payments 345,537 Imputed interest (6,129) Lease liability $ 339,408 |
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) | 3 Months Ended |
Mar. 31, 2024 | |
Warrants | |
Summary of company's outstanding or issuable warrant | The following table summarizes the Company’s outstanding or issuable warrants at March 31, 2024: Number Exercise Price Description of Shares Per Share IPO Underwriter Warrants 391 $ 4,000 February Placement Agent Warrants 249 527 Consultant Warrants 156 400 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 January 2024 Common Stock Purchase Warrants 11,885,246 1.22 January 2024 Placement Agent Warrants 356,557 1.525 |
Share-Based Compensation (Table
Share-Based Compensation (Table) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2022 3,771 $ 592.00 5.3 Granted 2,911 226.88 6.4 Exercised — — — Forfeited (393) 459.02 — Outstanding at December 31, 2023 6,289 419.58 3.7 Granted — — — Exercised — — — Forfeited (414) 819.52 — Outstanding at March 31, 2024 5,875 $ 407.11 3.9 |
Schedule of assumptions to determine the grant-date fair value of options granted | Year ended December 31, 2023 Risk-free interest rate 4.01% - 4.72% Expected term (in years) 6.0 Expected volatility 100.6% - 100.8% Expected dividend yield — Fair value per share of underlying stock $226.80 - $238.80 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Schedule of computation of basic and diluted loss per share | Three months ended March 31, 2024 2023 Basic and diluted loss per share Net loss $ (3,326,812) $ (4,816,934) Weighted-average common shares outstanding 5,142,398 18,593 Net loss per share $ (0.65) $ (259.07) |
Nature of Business and Liquid_2
Nature of Business and Liquidity - IPO (Details) - IPO $ / shares in Units, $ in Thousands | Jul. 13, 2021 USD ($) $ / shares shares |
Nature of Business and Liquidity | |
Gross proceeds | $ | $ 28,750 |
Shares issued (in shares) | 8,984 |
Price per share (in dollars per share) | $ / shares | $ 3,200 |
Net proceeds | $ | $ 25,400 |
Number of shares of common stock called by warrants | 391 |
Exercise price | $ / shares | $ 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 ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Nature of Business and Liquidity | |||
Net cash used in operating activities | $ 3,937,227 | $ 4,513,551 | |
Net loss | (3,326,812) | $ (4,816,934) | |
Accumulated deficit | (49,743,156) | $ (46,416,344) | |
Cash | $ 4,913,676 | $ 2,767,598 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Estimated useful life of property and equipment (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Reverse stock split ratio | 1 |
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 ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid Expenses and Other Current Assets | ||
Prepaid operating expenses | $ 97,324 | $ 116,607 |
Contract manufacturers and research organizations | 1,061,170 | 717,686 |
Insurance premiums | 219,360 | 431,061 |
Prepaid FICA | 422,492 | 422,492 |
Prepaid expenses and other current assets | $ 1,800,346 | $ 1,687,846 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Property and Equipment | |||
Laboratory and computer equipment | $ 387,886 | $ 384,050 | |
Less accumulated depreciation | (295,507) | (263,343) | |
Total property and equipment, net | 92,379 | $ 120,707 | |
Depreciation expense | $ 32,164 | $ 29,640 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Accounts Payable and Accrued Expenses | ||
Professional and general consulting fees | $ 667,538 | $ 375,550 |
R&D-related - CMOs, CROs, supplies, equipment and consulting | 919,816 | 1,260,578 |
General expenses | 139,845 | 295,508 |
Insurance premiums | 128,149 | 400,236 |
Payroll and benefits | 202,361 | 589,404 |
Accrued license payments | 309,055 | 129,983 |
Total accounts payable and accrued expenses | 2,366,764 | 3,051,259 |
Outstanding payables to CROs or CMOs | $ 634,512 | $ 1,020,875 |
Grant Income (Details)
Grant Income (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 15 Months Ended | |||||
Apr. 30, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | 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 | $ 27,057 | $ 79,409 | ||||||
Grant income receivable | $ 0 | |||||||
Deferred grant income | $ 0 | $ 0 | $ 27,057 |
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 | Mar. 31, 2024 $ / ft² | |
Leases | ||||
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 | $ 900,000 | |||
Total sublease commitment | $ 900,000 | |||
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 ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments and Contingencies | ||
Weighted average remaining lease term (years) | 9 months 18 days | |
Weighted average discount rate | 3.60% | |
2024 | $ 307,246 | |
2025 | 38,291 | |
Total undiscounted lease payments | 345,537 | |
Imputed interest | (6,129) | |
Lease liability | 339,408 | |
Rent expense | $ 109,483 | $ 126,944 |
Commitments and Contingencies_3
Commitments and Contingencies - License Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Nov. 30, 2020 | Oct. 31, 2020 | Nov. 30, 2018 | Mar. 31, 2024 | Dec. 31, 2023 | |
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 | $ 309,055 | $ 129,983 |
Commitments and Contingencies_4
Commitments and Contingencies - Collaboration Agreement and Litigation (Details) - USD ($) | 3 Months Ended | 15 Months Ended | |
Jul. 29, 2022 | Mar. 31, 2024 | Mar. 31, 2024 | |
Employee Severance | Maximum | |||
Commitments and Contingencies | |||
Aggregate amount of severance | $ 1,031,400 | ||
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 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 1 Months Ended | 3 Months Ended | ||||||||||
Jan. 22, 2024 USD ($) $ / shares shares | Dec. 04, 2023 USD ($) $ / shares shares | Oct. 05, 2023 shares | Sep. 26, 2023 $ / shares shares | Jun. 06, 2023 USD ($) $ / shares shares | Feb. 16, 2023 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) | May 31, 2023 USD ($) shares | Apr. 30, 2023 USD ($) shares | Mar. 31, 2024 USD ($) Vote $ / shares shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 $ / 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 | ||||||||||
Common stock, shares issued | 5,808,053 | 627,448 | ||||||||||
Common stock, share outstanding | 5,808,053 | 627,448 | ||||||||||
Preferred stock, shares issued | 0 | 0 | ||||||||||
Net proceeds from sales of common stock | $ | $ 6,087,141 | $ 1,180,686 | ||||||||||
Common Stock - Dividends and Voting | ||||||||||||
Cash dividends were declared or paid | $ | $ 0 | |||||||||||
Common stock voting rights per share | Vote | 1 | |||||||||||
Series A-1 Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 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 | |||||||||||
Exercise price | $ / shares | $ 175.20 | |||||||||||
February Placement Agent Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 249 | |||||||||||
Exercise price | $ / shares | $ 527 | |||||||||||
December Placement Agent Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 7,500 | |||||||||||
Exercise price | $ / shares | $ 12.10 | |||||||||||
January Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 11,885,246 | |||||||||||
Exercise price | $ / shares | $ 1.22 | |||||||||||
January Placement Agent Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 356,557 | |||||||||||
Exercise price | $ / shares | $ 1.525 | |||||||||||
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 | ||||||||||||
Aggregate of direct offering | 428,924 | 125,000 | 3,558 | |||||||||
Net proceeds from sales of common stock | $ | $ 6,100,000 | $ 900,000 | $ 1,200,000 | |||||||||
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 | $ 1.22 | $ 9.68 | $ 140 | $ 421.60 | ||||||||
Securities Purchase Agreement | Pre-funded warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants purchased | 814,000 | |||||||||||
Number of warrants sold | 5,513,699 | 47,525 | ||||||||||
Exercise price | $ / shares | $ 0.01 | $ 0.40 | ||||||||||
Price per share (in dollars per share) | $ / shares | $ 1.21 | $ 139.60 | ||||||||||
Securities Purchase Agreement | Series A warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Term of warrants | 3 years | |||||||||||
Exercise price | $ / shares | $ 130 | |||||||||||
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 | February Placement Agent Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Sale of stock exercise price | $ / shares | $ 527 | |||||||||||
Number of warrants purchased | 249 | |||||||||||
Term of warrants | 5 years | |||||||||||
Exercise price | $ / shares | $ 527 | |||||||||||
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 | January Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Term of warrants | 3 years 6 months | |||||||||||
Number of warrants sold | 11,885,246 | |||||||||||
Exercise price | $ / shares | $ 1.22 | |||||||||||
Securities Purchase Agreement | January Placement Agent Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Term of warrants | 3 years 6 months | |||||||||||
Number of warrants sold | 356,558 | |||||||||||
Exercise price | $ / shares | $ 1.525 | |||||||||||
Over-Allotment Option | ||||||||||||
Stockholders' Equity | ||||||||||||
Issuances of common stock, net (in shares) | 8,348 | |||||||||||
Over-Allotment Option | Underwriter Warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants sold | 417 | |||||||||||
Underwriting Agreement | ||||||||||||
Stockholders' Equity | ||||||||||||
Issuances of common stock, net (in shares) | 17,500 | |||||||||||
Net proceeds | $ | $ 6,700,000 | |||||||||||
Price per share (in dollars per share) | $ / shares | $ 20.40 | |||||||||||
Underwriting Agreement | Pre-funded warrants | ||||||||||||
Stockholders' Equity | ||||||||||||
Number of warrants sold | 404,075 | |||||||||||
Exercise price | $ / shares | $ 0.40 | |||||||||||
Price per share (in dollars per share) | $ / shares | $ 20 | |||||||||||
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 | 21,079 | ||||||||||
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) | 5,180,605 | 3,558 | ||||||||||
Preferred Stock | ||||||||||||
Stockholders' Equity | ||||||||||||
Maximum number of shares which the Company is authorized to issue | 10,000,000 |
Warrants (Details)
Warrants (Details) - $ / shares | Jan. 22, 2024 | Oct. 05, 2023 | Sep. 26, 2023 | Jun. 06, 2023 | Feb. 16, 2023 | Mar. 31, 2024 | Dec. 04, 2023 | Jul. 13, 2021 |
Underwriting Agreement | ||||||||
Warrants | ||||||||
Shares issued (in shares) | 17,500 | |||||||
Price per share (in dollars per share) | $ 20.40 | |||||||
Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Shares issued (in shares) | 2,475 | |||||||
Price per share (in dollars per share) | $ 1.22 | $ 140 | $ 421.60 | $ 9.68 | ||||
Commencement period for exercise of warrants, following the date of issuance | 6 months | |||||||
Over-Allotment Option | ||||||||
Warrants | ||||||||
Shares issued (in shares) | 8,348 | |||||||
IPO Underwriter Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 391 | 391 | ||||||
Exercise price (in dollars per share) | $ 4,000 | $ 4,000 | ||||||
Underwriter Initial public offering price (in percentage) | 125% | |||||||
Term of warrants | 5 years | |||||||
February Placement Agent Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 249 | |||||||
Exercise price (in dollars per share) | $ 527 | |||||||
February Placement Agent Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants purchased | 249 | |||||||
Exercise price (in dollars per share) | $ 527 | |||||||
Term of warrants | 5 years | |||||||
Sale of stock exercise price | $ 527 | |||||||
Consultant warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 156 | |||||||
Exercise price (in dollars per share) | $ 400 | |||||||
Consultant warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants purchased | 156 | |||||||
Exercise price (in dollars per share) | $ 400 | |||||||
June Placement Agent Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 3,500 | |||||||
Exercise price (in dollars per share) | $ 175.20 | |||||||
June Placement Agent Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants purchased | 3,500 | |||||||
Exercise price (in dollars per share) | $ 175 | |||||||
Term of warrants | 3 years | |||||||
Pre-funded warrants | Underwriting Agreement | ||||||||
Warrants | ||||||||
Exercise price (in dollars per share) | 0.40 | |||||||
Price per share (in dollars per share) | $ 20 | |||||||
Number of warrants sold | 404,075 | |||||||
Pre-funded warrants | Underwriting Agreement | Maximum | ||||||||
Warrants | ||||||||
Number of warrants purchased | 58,480 | |||||||
Pre-funded warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants purchased | 814,000 | |||||||
Exercise price (in dollars per share) | 0.01 | $ 0.40 | ||||||
Price per share (in dollars per share) | $ 1.21 | $ 139.60 | ||||||
Number of warrants sold | 5,513,699 | 47,525 | ||||||
Series A warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Exercise price (in dollars per share) | $ 130 | |||||||
Term of warrants | 3 years | |||||||
Series A-1 Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 50,000 | |||||||
Exercise price (in dollars per share) | $ 130 | |||||||
Series A-1 Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants sold | 50,000 | |||||||
Series A-2 Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 50,000 | |||||||
Exercise price (in dollars per share) | $ 130 | |||||||
Series A-2 Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants sold | 50,000 | |||||||
Underwriter Warrants | Underwriting Agreement | ||||||||
Warrants | ||||||||
Exercise price (in dollars per share) | $ 25.50 | |||||||
Term of warrants | 5 years | |||||||
Commencement period for exercise of warrants, following the date of issuance | 180 days | |||||||
Underwriter Warrants | Underwriting Agreement | Maximum | ||||||||
Warrants | ||||||||
Number of warrants purchased | 21,496 | 21,079 | ||||||
Underwriter Warrants | Over-Allotment Option | ||||||||
Warrants | ||||||||
Number of warrants sold | 417 | |||||||
December Placement Agent Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 7,500 | |||||||
Exercise price (in dollars per share) | $ 12.10 | |||||||
December Placement Agent Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Number of warrants purchased | 7,500 | |||||||
Exercise price (in dollars per share) | $ 12.10 | |||||||
Term of warrants | 5 years | |||||||
January Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 11,885,246 | |||||||
Exercise price (in dollars per share) | $ 1.22 | |||||||
January Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Exercise price (in dollars per share) | $ 1.22 | |||||||
Term of warrants | 3 years 6 months | |||||||
Number of warrants sold | 11,885,246 | |||||||
January Placement Agent Warrants | ||||||||
Warrants | ||||||||
Number of warrants purchased | 356,557 | |||||||
Exercise price (in dollars per share) | $ 1.525 | |||||||
January Placement Agent Warrants | Securities Purchase Agreement | ||||||||
Warrants | ||||||||
Exercise price (in dollars per share) | $ 1.525 | |||||||
Term of warrants | 3 years 6 months | |||||||
Number of warrants sold | 356,558 |
Warrants - Summary of Company's
Warrants - Summary of Company's Outstanding or Issuable Warrants (Details) - $ / shares | Mar. 31, 2024 | Jul. 13, 2021 |
IPO Underwriter Warrants | ||
Warrants | ||
Number of warrants purchased | 391 | 391 |
Exercise price (in dollars per share) | $ 4,000 | $ 4,000 |
February Placement Agent Warrants | ||
Warrants | ||
Number of warrants purchased | 249 | |
Exercise price (in dollars per share) | $ 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 | |
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 | |
Exercise price (in dollars per share) | $ 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 | |
January Warrants | ||
Warrants | ||
Number of warrants purchased | 11,885,246 | |
Exercise price (in dollars per share) | $ 1.22 | |
January Placement Agent Warrants | ||
Warrants | ||
Number of warrants purchased | 356,557 | |
Exercise price (in dollars per share) | $ 1.525 |
Share-Based Compensation - Info
Share-Based Compensation - Information about Plans (Details) - shares | 3 Months Ended | |||||||
Mar. 31, 2024 | Jan. 31, 2024 | Dec. 31, 2023 | Jan. 31, 2023 | Dec. 31, 2022 | Jan. 31, 2022 | Mar. 31, 2021 | Apr. 30, 2020 | |
Share-Based Compensation | ||||||||
Terms of award | 10 | |||||||
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 | |||||||
Number of stock options outstanding | 5,875 | 6,289 | 3,771 | |||||
Minimum | ||||||||
Share-Based Compensation | ||||||||
Vesting period | 2 years | |||||||
Maximum | ||||||||
Share-Based Compensation | ||||||||
Vesting period | 4 years | |||||||
Stock Option and Incentive Plan 2020 | ||||||||
Share-Based Compensation | ||||||||
Shares approved for issuance of options or other awards | 3,791 | |||||||
Options vested and exercisable | 1,930 | |||||||
Stock Option and Incentive Plan 2021 | ||||||||
Share-Based Compensation | ||||||||
Shares approved for issuance of options or other awards | 6,250 | |||||||
Options available for future grants | 31,372 | 811 | 807 | |||||
Number of stock options outstanding | 3,905 | |||||||
Options vested and exercisable | 3,486 |
Share-Based Compensation - In_2
Share-Based Compensation - Information About Options to Purchase Common Stock (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Number of shares | |||
Outstanding, beginning balance | 6,289 | 3,771 | |
Granted | 0 | 2,911 | |
Forfeited | (414) | (393) | |
Outstanding, ending balance | 5,875 | 6,289 | 3,771 |
Weighted average exercise price per share | |||
Outstanding, beginning balance | $ 419.58 | $ 592 | |
Granted | 226.88 | ||
Forfeited | 819.52 | 459.02 | |
Outstanding, ending balance | $ 407.11 | $ 419.58 | $ 592 |
Weighted average contractual term (years) | |||
Weighted average contractual term (years) | 3 years 10 months 24 days | 3 years 8 months 12 days | 5 years 3 months 18 days |
Granted | 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) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Compensation | ||
Number of Options | 0 | 2,911 |
Employee Stock Option | ||
Assumptions Used to Determine the Grant-Date Fair Value of Options Granted | ||
Risk-free interest rate, minimum | 4.01% | |
Risk-free interest rate, maximum | 4.72% | |
Expected term (in years) | 6 years | |
Expected volatility, minimum | 100.60% | |
Expected volatility, maximum | 100.80% | |
Employee Stock Option | Minimum | ||
Assumptions Used to Determine the Grant-Date Fair Value of Options Granted | ||
Fair value per share of underlying stock | $ 226.80 | |
Employee Stock Option | Maximum | ||
Assumptions Used to Determine the Grant-Date Fair Value of Options Granted | ||
Fair value per share of underlying stock | $ 238.80 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation | ||
Remaining unrecognized option compensation expense | $ 109,119 | |
Employee Stock Option | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 183,152 | $ 158,760 |
Period for recognition of stock-based compensation expense | 2 years 2 months 12 days |
Employee Stock Purchase Plan (D
Employee Stock Purchase Plan (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Jan. 31, 2022 | |
Employee Stock Purchase Plan | ||
Shares issued on ESPP | 188 | |
Shares available in ESPP | 113 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of basic and diluted loss per share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator | ||
Net loss | $ (3,326,812) | $ (4,816,934) |
Denominator | ||
Weighted-average common shares outstanding, Basic | 5,142,398 | 18,593 |
Weighted-average common shares outstanding, Diluted | 5,142,398 | 18,593 |
Net loss per share, Basic | $ (0.65) | $ (259.07) |
Net loss per share, Diluted | $ (0.65) | $ (259.07) |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Income Taxes | |||
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 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (3,326,812) | $ (4,816,934) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
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 |