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    SEC Form 10-Q filed by Shuttle Pharmaceuticals Holdings Inc.

    5/8/25 5:29:46 PM ET
    $SHPH
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $SHPH alert in real time by email
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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    FORM 10-Q

     

    (Mark One)

     

      ☒ Quarterly Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934

     

    For the quarterly period ended March 31, 2025

     

    OR

     

      ☐ Transition Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934

     

    For the transition period from ______________ to ______________

     

    Commission File Number 001-41488

     

    SHUTTLE PHARMACEUTICALS HOLDINGS, INC.

    (Exact name of registrant as specified in its charter)

     

    Delaware   82-5089826
    (State or other jurisdiction of   (I.R.S. Employer
    incorporation or organization)   Identification Number)

     

    401 Professional Drive, Suite 260

    Gaithersburg, MD 20879

    (Address of principal executive offices) (Zip Code)

     

    (240) 403-4212

    (Registrant’s telephone number, including area code)

     

    N/A

    (Former name, former address and former fiscal year, if changed since last report)

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class   Trading Symbol(s)   Name of each exchange on which registered
    Common Stock, par value $0.00001 per share   SHPH   The Nasdaq Stock Market LLC

     

    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

     

    Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

     

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

     

      Large accelerated filer ☐ Accelerated filer ☐
      Non-accelerated filer ☒ Smaller reporting company ☒
          Emerging growth company ☒

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

     

    The number of shares outstanding of the registrant’s common stock on May 8, 2025 was 10,984,291.

     

     

     

     

     

     

    Shuttle Pharmaceuticals Holdings, Inc.

     

    TABLE OF CONTENTS

     

       

    Page

      Part I. Financial Information  
         
    Item 1. Unaudited Condensed Consolidated Financial Statements  
      Unaudited Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 3
      Unaudited Condensed Consolidated Statements of Operations for the three months ended March 31, 2025 and 2024 4
      Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three months ended March 31, 2025 and 2024 5
      Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 6
      Notes to Unaudited Condensed Consolidated Financial Statements 7
         
    Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 24
    Item 3. Quantitative and Qualitative Disclosures About Market Risk 30
    Item 4. Controls and Procedures 30
         
      Part II. Other Information 32
         
    Item 1. Legal Proceedings 32
    Item 1A. Risk Factors 32
    Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 32
    Item 3. Defaults Upon Senior Securities 32
    Item 4. Mine Safety Disclosures 32
    Item 5. Other Information 32
    Item 6. Exhibits 32
    Signatures 33

     

    2

     

     

    Shuttle Pharmaceuticals Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

     

       March 31,   December 31, 
       2025   2024 
    Assets          
    Current assets          
    Cash and cash equivalents  $4,512,607   $1,920,144 
    Prepaid expenses   446,790    290,773 
    Total current assets   4,959,397    2,210,917 
               
    Property and equipment, net   18,356    19,364 
    Deferred financing costs   71,880    — 
    Operating lease right-of-use asset   260,557    276,009 
    Total Assets   5,310,190    2,506,290 
               
    Liabilities and Stockholders’ Equity          
    Current Liabilities          
    Accounts payable and accrued expenses  $896,885   $596,600 
    Accrued interest payable - related parties   1,208    1,785 
    Notes payable to related parties   128,730    190,270 
    Convertible notes payable, net - fair value option, related parties   217,379    206,085 
    Convertible notes payable, net - fair value option   474,749    478,120 
    Operating lease liability   63,226    60,909 
    Total Current Liabilities   1,782,177    1,533,769 
               
    Derivative liability   22,638    25,281 
    Operating lease liability non-current   220,110    238,088 
    Total Liabilities   2,024,925    1,797,138 
               
    Commitments and contingencies (Note 8)   -    - 
               
    Stockholders’ Equity          
    Series A Convertible Preferred Stock, $0.00001 par value; $1,000 per share liquidation value; 20,000,000 shares authorized; no shares outstanding   —    — 
    Common stock, $0.00001 par value; 100,000,000 shares authorized; 6,382,694 shares issued and outstanding at March 31, 2025; 4,076,567 shares issued and outstanding at December 31, 2024   63    41 
    Additional paid in capital   40,916,310    35,287,212 
    Accumulated deficit   (37,631,108)   (34,578,101)
    Total Stockholders’ Equity   3,285,265    709,152 
    Total Liabilities and Stockholders’ Equity  $5,310,190   $2,506,290 

     

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

     

    3

     

     

    Shuttle Pharmaceuticals Holdings, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

     

       2025   2024 
       Three Months Ended 
       March 31, 
       2025   2024 
             
    Revenue  $—    — 
               
    Operating expenses          
    Research and development   1,573,928    586,104 
    General and administrative   596,886    324,609 
    Legal and professional   780,427    474,134 
    Total operating expenses   2,951,241    1,384,847 
               
    Net loss from operations   (2,951,241)   (1,384,847)
               
    Other income (expense)          
    Interest expense - related parties   (5,395)   — 
    Interest expense   (6,535)   (497,515)
    Interest income   —    21,453 
    Change in fair value of derivative liabilities   2,643    197,862 
    Change in fair value of convertible notes   (92,479)   — 
    Gain on sale of marketable securities   —    4,037 
    Change in fair value of marketable securities   —    (706)
    Loss on settlement of convertible debt   —    (71,315)
    Total other income (expense)   (101,766)   (346,184)
               
    Net loss   (3,053,007)   (1,731,031)
               
    Weighted average common shares outstanding - basic and diluted   10,048,915    2,075,745 
    Net loss per shares - basic and diluted  $(0.30)  $(0.83)

     

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

     

    4

     

     

    Shuttle Pharmaceuticals Holdings, Inc.

    Condensed Consolidated Statements of Changes in Stockholders’ Equity

    (Unaudited)

     

    For the Three Months Ended March 31, 2025

     

       Shares   Amount   Capital   Deficit   Equity 
               Additional       Total 
       Common Stock   Paid-In   Accumulated   Stockholders’ 
       Shares   Amount   Capital   Deficit   Equity 
    Balance at December 31, 2024   4,076,567   $41   $35,287,212   $(34,578,101)  $709,152 
    Common stock issued for restricted stock units   840,206    8    (8)   —    — 
    Issuance of common stock and pre-funded warrants, net of issuance costs of $693,600   1,340,921    13    5,038,561    —    5,038,574 
    Partial conversion of convertible note at fair value   125,000    1    53,499    —    53,500 
    Stock-based compensation   —    —    537,046    —    537,046 
    Net loss   —    —    —    (3,053,007)       (3,053,007)
    Balance at March 31, 2025   6,382,694   $63   $40,916,310   $(37,631,108)  $3,285,265 

     

    For the Three Months Ended March 31, 2024

     

               Additional       Total 
       Common Stock   Paid-In   Accumulated   Stockholders’ 
       Shares   Amount   Capital   Deficit   Equity 
    Balance at December 31, 2023   2,008,689    20    29,489,055    (25,433,304)   4,055,771 
    Balance   2,008,689    20    29,489,055    (25,433,304)   4,055,771 
    Common stock issued for conversion of accrued interest and principal   78,197    1    325,297    —    325,298 
    Common stock issued for restricted stock units   15,625    —    —    —    — 
    Stock-based compensation   —    —    111,449    —    111,449 
    Net loss   —    —    —    (1,731,031)   (1,731,031)
    Balance at March 31, 2024   2,102,511    21    29,925,801    (27,164,335)   2,761,487 
    Balance   2,102,511    21    29,925,801    (27,164,335)   2,761,487 

     

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

     

    5

     

     

    Shuttle Pharmaceuticals Holdings, Inc.

    Condensed Consolidated Statements of Cash Flows

    (Unaudited)

     

       2025   2024 
       Three Months Ended 
       March 31, 
       2025   2024 
    CASH FLOWS FROM OPERATING ACTIVITIES:          
    Net loss  $(3,053,007)  $(1,731,031)
    Adjustments to reconcile net loss to net cash used in operating activities:          
    Depreciation   1,008    1,912 
    Change in fair value of derivative liabilities   (2,643)   (197,862)
    Amortization of debt discount and finance fees   6,535    445,509 
    Gain on marketable securities   —    (4,037)
    Change in fair value of marketable securities   —    706 
    Accrued interest settled with common stock   —    18,783 
    Loss on settlement of convertible debt   —    71,315 
    Stock-based compensation   537,046    111,449 
    Interest payments on convertible notes accounted for at fair value   (31,056)   — 
    Change in fair value of convertible notes   92,479    — 
    Changes in operating assets and liabilities:          
    Accrued interest income   —    2,937 
    Prepaid expenses   (156,017)   (15,169)
    Accounts payable and accrued expenses   79,517    23,162 
    Accounts payable and accrued expenses - related parties   —    (446)
    Accrued interest payable   —    33,223 
    Accrued interest payable - related parties   (577)   — 
    Change in operating lease asset and liabilities   (209)   466 
    Net cash used in operating activities   (2,526,924)   (1,239,083)
               
    CASH FLOWS FROM INVESTING ACTIVITIES:          
    Investment in marketable securities   —    (18,705)
    Proceeds from disposition of marketable securities   —    120,000 
    Net cash provided by investing activities   —    101,295 
               
    CASH FLOWS FROM FINANCING ACTIVITIES:          
    Repayment of note payable-related party   (61,540)   — 
    Proceeds from issuance of common stock and pre-funded warrants, net of placement agent costs of $322,501   5,409,673    — 
    Payment of other issuance costs for issuance of common stock and equity-classified warrants   (178,745)   — 
    Payment for finance costs   (50,001)   (40,000)
    Net cash provided by (used in) financing activities   5,119,387    (40,000)
               
    Net change in cash and cash equivalents   2,592,463    (1,177,788)
    Cash and cash equivalents, beginning of period   1,920,144    2,576,416 
    Cash and cash equivalents, end of period  $4,512,607   $1,398,628 
               
    Cash paid for:          
    Interest  $36,153   $— 
    Income taxes  $—   $— 
               
    Supplemental non-cash financing activities:          
    Issuance costs in accounts payable and accrued expenses  $192,354   $— 
    Common stock issued for RSUs  $8   $— 
    Conversion of convertible notes accounted for at fair value  $53,500   $— 
    Finance costs accrued in accounts payable  $28,414   $41,534 
    Common stock issued for settlement of debt  $—   $325,298 

     

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

     

    6

     

     

    Note 1 – Organization and Liquidity

     

    Organization and Line of Business

     

    Shuttle Pharmaceuticals Holdings, Inc. (“we,” “us,” “our,” or the “Company”) was originally formed as Shuttle Pharmaceuticals, LLC in the State of Maryland on December 18, 2012. On August 12, 2016, the Company filed articles of conversion with the State of Maryland to convert from an LLC to a C corporation, at which time the Company changed its name to Shuttle Pharmaceuticals, Inc. (“Shuttle”). In connection with the conversion, the Company issued 5,625,000 shares of common stock in exchange for 100% of the outstanding membership interests in Shuttle prior to conversion. On June 4, 2018, Shuttle completed a reverse merger with Shuttle Pharmaceuticals Holdings, Inc. (then known as Shuttle Pharma Acquisition Corp, Inc.), a Delaware corporation, pursuant to which Shuttle, our operating entity, became a wholly-owned subsidiary of the Company. Shuttle Diagnostics, Inc, a subsidiary of the Company, was formed in the State of Maryland on November 14, 2023.

     

    The Company’s primary purpose is to develop and commercialize unique drugs for the sensitization of cancers and protection of normal tissues, with the goal of improving outcomes for cancer patients receiving radiation therapy. Shuttle has deployed its proprietary technology to develop novel cancer immunotherapies, producing a pipeline of selective HDAC inhibitors for cancer and immunotherapy applications. The Company’s HDAC platform is designed to target candidate molecules with potential roles in therapeutics beyond cancer, including autoimmune, inflammatory, metabolic, neurological and infectious diseases. The Company’s Ropidoxuridine product, which is used with radiation therapy to sensitize cancer cells, was initially funded by a Small Business Innovation Research (“SBIR”) contract provided by the National Cancer Institute (“NCI”), a unit of the National Institutes of Health (“NIH”). Ropidoxuridine has been further developed through the Company’s collaborations with scientists at the University of Virginia for use in combination with proton therapy to improve patient survival. Historically, and prior to the Company’s initial public offering in September 2022, the Company had obtained funding to develop products through NIH grants, including a product to predict late effects of radiation with metabolite biomarkers and develop prostate cancer cell lines in health disparities research.

     

    The production and marketing of the Company’s products and its ongoing research and development activities will be and are subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any products or combination of products developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the Food and Drug Administration (“FDA”) under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems in its clinical trials that will cause the Company or the FDA to delay or suspend the clinical trials.

     

    The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and in other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company now or in the future.

     

    Liquidity and Going Concern

     

    Our unaudited condensed consolidated financial statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred losses since inception and has a net loss of approximately $3.0 million and no revenues for the three months ended March 31, 2025 and working capital of approximately $3.2 million as of March 31, 2025. The Company does not expect to generate positive cash flows from operating activities in the near future.

     

    In February 2025, the Company issued a revolving note in the principal amount of up to $2,000,000, which the Company may draw upon at its discretion from time to time. In March 2025, the Company completed an equity raise that provided $5.0 million net cash proceeds for the issuance of 1.3 million shares and 17.8 million pre-funded warrants. However, the Company’s existing cash resources, the cash received from the equity offering, and financing available under the revolving note are not expected to provide sufficient funds to carry out the Company’s operations and clinical trials through the next twelve months.

     

    7

     

     

    The ability of the Company to continue as a going concern is dependent upon its ability to continue to successfully raise additional equity or debt financing to allow it to fund ongoing operations, conduct clinical trials and bring a drug candidate to commercialization to generate revenues. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued.

     

    The accompanying unaudited condensed consolidated financial statements do not include any adjustments to reflect the future effects on the recoverability and classification of assets or the amounts and classification of liabilities if the Company is unable to continue as a going concern.

     

    Note 2 – Summary of Significant Accounting Policies

     

    Basis of Presentation

     

    The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial statements and with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X of the United States Securities and Exchange Commission (“SEC”). Accordingly, they do not contain all information and notes required by GAAP for annual financial statements. A complete discussion of the Company’s significant accounting policies is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

     

    In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all of the adjustments necessary to present the financial position of the Company as of March 31, 2025 and the results of operations and cash flows for the periods presented. The accompanying condensed consolidated financial statements of the Company have not been audited by the Company’s independent registered public accounting firm, except that the year-end consolidated balance sheet was derived from audited financial statements. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the operating results for the full fiscal year or any future period.

     

    Reverse Stock Split

     

    On August 13, 2024, in order to meet Nasdaq’s minimum bid price requirement of $1.00 per share (the “Minimum Bid Price Requirement”), the Company effectuated a 1-for-8 reverse stock split of its issued and outstanding common stock, rounding up to account for any fractional shares (the “Reverse Stock Split”). The Reverse Stock Split had no effect on the Company’s authorized shares of common stock or preferred stock and the par value will remain unchanged at $0.00001, respectively. All common stock share, option, warrant and per share amounts (except our authorized but unissued shares and previously reserved shares) have been retroactively adjusted in these unaudited condensed consolidated financial statements and related disclosures.

     

    Basis of Consolidation

     

    The unaudited condensed consolidated financial statements have been prepared on a consolidated basis with those of the Company’s wholly-owned subsidiaries, Shuttle Pharmaceuticals, Inc. and Shuttle Diagnostics, Inc. All intercompany transactions and balances have been eliminated.

     

    Use of Estimates

     

    The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company regularly evaluates estimates and assumptions. The Company bases its estimates and assumptions on current facts, historical experience, and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected. Significant estimates are contained in the accompanying unaudited condensed consolidated financial statements for the valuation of debt and warrants and valuation of bifurcated derivative liabilities and other financial instruments.

     

    8

     

     

    Cash and Cash Equivalents

     

    Cash and cash equivalents include cash in bank accounts and money market funds with maturities of less than three months from inception, which are readily convertible to known amounts of cash and which, in the opinion of management, are subject to an insignificant risk of loss in value. As of March 31, 2025 and December 31, 2024, cash and cash equivalents consisted of the following:

     Schedule of Cash and Cash Equivalents

      March 31,   December 31,
      2025   2024
    Cash $ 4,511,790   $ 1,918,941
    Money market funds  817    1,203
    Total cash and cash equivalents $ 4,512,607   $ 1,920,144

     

    Periodically, the Company may carry cash balances at financial institutions in excess of the federally insured limit of $250,000 per institution. The amount in excess of the FDIC insurance as of March 31, 2025 was approximately $4.3 million. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.

     

    Fair Value of Financial Instruments

     

    The Company follows accounting guidelines on fair value measurements for financial instruments measured on a recurring basis, as well as for certain assets and liabilities that are initially recorded at their estimated fair values. Fair value is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The Company uses the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments:

     

      ● Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments
         
      ● Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
         
      ● Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires a significant judgment or estimation.

     

    Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires the Company to make judgments and consider factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed, or initial amounts recorded, may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange.

     

    The carrying amounts of the Company’s financial instruments including cash and cash equivalents, prepaid expenses, accounts payable and accrued liabilities approximate fair value due to the short-term maturities of these instruments.

    9

     

     

    Set out below are the Company’s financial instruments that are required to be remeasured at fair value on a recurring basis and their fair value hierarchy as of March 31, 2025 and December 31, 2024:

     Schedule of Fair Value Liabilities Measured on Recurring Basis

    March 31, 2025  Level 1   Level 2   Level 3   Carrying Value 
    Liabilities                    
    Derivative Liability - Warrants  $—   $—   $22,638   $22,638 
    Convertible Note  —   —   692,128   692,128 
    Total Liabilities  $—   $—   $714,766   $714,766 

     

    December 31, 2024  Level 1   Level 2   Level 3   Carrying Value 
    Liabilities                    
    Derivative Liability - Warrants  $—   $—   $25,281   $25,281 
    Convertible Note   

    —

        —    684,205    684,205 
    Total Liabilities  $—   $—   $709,486   $709,486 

     

    See Note 5 and Note 7 for additional disclosures related to the fair value of the Company’s convertible notes and derivative liabilities, respectively.

     

    Derivative Financial Instruments

     

    The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations.

     

    For its derivative financial instruments, the Company utilizes the most appropriate valuation model (such as Monte Carlo simulations or other sophisticated models, based on the nature of the terms of the instrument) to value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the consolidated balance sheet sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within twelve (12) months of the balance sheet date.

     

    Convertible Notes

     

    The Company accounts for its Convertible Bridge Notes (as defined in Note 5) under the fair value option in accordance with ASC 825. The fair value option may be elected on an instrument-by-instrument basis and is irrevocable unless a new election date occurs. Additional term or other notes may be issued in subsequent periods where the Company would be able to make a fair value option election upon issuance provided eligibility criteria are met. The Company records the portion of the Convertible Bridge Notes that are issued and outstanding for accounting purposes at fair value with changes in fair value recorded in other income (expense), net in the unaudited condensed consolidated statements of operations, except for the portion of the total change in fair value that results from a change in the instrument-specific credit risk of the Convertible Bridge Notes, which is recorded in other comprehensive income (loss), if applicable. No loss was attributed to changes in credit risk for the periods presented therefore net loss was equal to comprehensive loss. The fair value option election was made to align the accounting for the Convertible Bridge Notes with the Company’s financial reporting objectives and reduce operational effort to account for embedded features that otherwise would require bifurcation as a separate unit of account.

     

    Pursuant to the fair value option election, direct and incremental debt issuance costs and consideration paid to the lender related to the Convertible Bridge Notes were expensed as incurred and recorded in other income (expense), net in the unaudited condensed consolidated statements of operations.

     

    10

     

     

    For convertible notes for which the fair value option is not elected, the Company evaluates the convertible notes for embedded features and bifurcates these features (such as conversion options and redemption options) from their host instruments and accounts for them as free standing derivative financial instruments if certain criteria are met. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. All of the Company’s convertible bridge notes as of March 31, 2025 had elected the fair value option at the initial transaction date.

     

    Warrants

     

    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 FASB 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 the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. Finally, the Company determines if the warrants meet the definition of a derivative based on their contractual terms. 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 of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital 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 at their initial fair value on the date of issuance, and at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the unaudited condensed consolidated statements of operations. The Company also evaluates if changes in contractual terms or other considerations would result in the reclassification of outstanding warrants from liabilities to stockholders’ equity (or vice versa).

     

    The fair value of the warrants is estimated using a Monte Carlo simulation. Warrants that have terms greater than one year are classified as non-current liabilities in the balance sheet, unless there is an indication that the warrants would be settled within one year.

     

    Stock-Based Compensation

     

    Compensation cost for stock awards, which include restricted stock units (“RSUs”), is measured at the fair value on the grant date and recognized as expense, over the related service period. The fair value of stock awards is based on the quoted price of our common stock on the grant date. Compensation expense related to the RSUs is reduced by the fair value of the units that are forfeited by employees that leave the Company prior to vesting as they occur. Compensation cost for RSUs is recognized using the straight-line method over the requisite service period.

     

    Research and Development Expenses

     

    Research and development expenses are charged to expense as incurred. Research and development expenses include, but are not limited to, product development, clinical and regulatory expenses, payroll and other personnel expenses, which include a certain portion of the Company’s former chief executive officer (prior to his transition to chief scientific officer), chief operating officer, vice president regulatory (formerly the chief financial officer) and directors’ compensation. For the three months ended March 31, 2025 and 2024, a portion of personnel-related expenses and stock-based compensation expense for these individuals totaling $0.8 million and $0.2 million, respectively, was included within research and development due to their active involvement in the research and development activities, materials, supplies, related subcontract expenses, and consulting costs.

     

    11

     

     

    Regarding the accounting treatment for reimbursements, GAAP provides limited guidance on the accounting for government grants received by for-profit companies. In accordance with ASC Topic 832, Government Assistance, as adopted January 1, 2022, the Company discloses certain types of government assistance received in the notes to the consolidated financial statements that includes: a) the nature of the transaction including the nature of the assistance being given, b) the accounting policies being used to account for the transaction and c) other provisions of relevance, where required. Depending on the type of grant or contract, the Company understands there is more than one acceptable alternative for the accounting treatment – a reduction of costs, a deferred credit to be amortized, revenue or other income. The Company has concluded that reimbursements received for R&D expenses incurred are more akin to a reduction of costs and applies reimbursements against incurred research costs. For the three months ended March 31, 2025 and 2024, the Company recorded $1.6 million and $0.6 million, respectively, in research and development.

     

    Segment Information

     

    Operating segments are defined as components of an enterprise about which separate and discrete information is available for evaluation by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company’s CODM, its chief executive officer, evaluates the Company’s operations and manages its business as a single operating segment. All of the Company’s long-lived assets are held in the United States. Refer to Note 9 for the Company’s disclosure on its 1 single operating segment.

     

    Net Loss Per Common Stock

     

    Net loss per share of common stock requires presentation of basic and diluted earnings per common share on the face of the condensed and consolidated statements of operations for all entities with complex capital structures and requires a reconciliation of the numerator and denominator of the basic earnings per share computation to diluted earnings per share.

     

    In the accompanying unaudited condensed consolidated financial statements, basic loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the year. Certain warrants issued and outstanding include terms and conditions resulting in the treatment as participating securities. Such warrants do not include an obligation for the warrant holders to fund the losses of the Company. Therefore, these warrants are excluded from the calculation of earnings per common share in periods of net loss.

     

    Diluted earnings per share is computed by dividing net income attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially dilutive shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through convertible securities, contingent share arrangements, stock options and warrants unless the result would be antidilutive.

     

    The dilutive effect of restricted stock units and other stock-based payment awards subject to vesting and common stock warrants is calculated using the “treasury stock method,” which assumes that the “proceeds” from the exercise of these instruments are used to purchase common shares at the average market price for the period. The dilutive effect of convertible securities is calculated using the “if-converted method.” Under the if-converted method, securities are assumed to be converted at the beginning of the period, and the resulting shares of common stock are included in the denominator of the diluted calculation for the entire period being presented.

     

    Given the nominal exercise price of the Company’s issuance of Pre-Funded Warrants (as defined in Note 6), such Pre-Funded Warrants are included in in the calculation of basic and diluted net loss per share as the exercise price per warrant is deemed nonsubstantive when compared to the fair value of the underlying common shares. The 19,651,746 unexercised pre-funded warrants as of March 31, 2025 were included in the Company’s calculation of basic and diluted loss per share.

     

    12

     

     

    For the three months ended March 31, 2025 and 2024, the following common stock equivalents were excluded from the computation of diluted net loss per share as the result of the computation was anti-dilutive.

      Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share

       March 31,   March 31, 
       2025   2024 
    Convertible notes (Note 5)   2,924,123    107,429 
    Warrants (Note 7)   3,464,281    184,000 
    Restricted stock units (Note 7)   796,925    34,106 
    Anti-dilutive securities   7,185,329    325,535 

     

    Recently Issued Accounting Pronouncements

     

    In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The guidance is effective for the Company’s fiscal years beginning after December 15, 2024. The Company will reflect any impact of adoption in its Form 10-K for the annual period ending December 31, 2025. The Company does not expect the adoption of this standard to have any material impact on its financial statements.

     

    On November 4, 2024, the FASB issued ASU 2024-03, “Disaggregation of Income Statement Expenses (“DISE”),” which requires disaggregated disclosure of income statement expenses for public business entities. The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the notes to the financial statements. ASU 2024-03 is effective for all public business entities for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.

     

    There have been no other recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended March 31, 2025 that are of significance or potential significance to the Company.

     

    Note 3 - Leases

     

    Operating lease right-of-use (“ROU”) assets and liabilities are recognized at the present value of the future lease payments as of the lease commencement date. Operating lease expense is recognized on a straight-line basis over the lease term.

     

    The Company currently has a lease agreement which allows for the use of a laboratory facility, entered into on February 16, 2023, with base rent of $7,206 per month for a period of 64 months, which increases at the rate of 3% per year, that commenced June 1, 2023. The lease included a six-month 50% rent abatement upon commencement. Additional common area maintenance (“CAM”) fees are charged monthly and revised annually. The estimated monthly CAM fees are $3,300 for the first year of the lease, which are being expensed as incurred. An irrevocable letter of credit (“LOC”) for the security deposit of $43,234 and base rent of $3,891, including 50% abatement, and $3,315 of CAM cost, was due and paid on execution of the lease agreement. Alexandria Real Estate (ARE-QRS-CORP) is the beneficiary of the LOC. The current LOC expires on March 1, 2026.

     

    13

     

     

    The following summarizes the right-of use asset and lease information for the Company’s operating leases:

     Schedule of Right-of Use Asset and Lease Information about Operating Lease

       2025   2024 
       Three Months Ended 
       March 31, 
       2025   2024 
    Operating lease cost  $22,947   $22,947 
    Variable lease cost   10,878    10,440 
    Sublease income   —    (2,163)
    Total lease cost  $33,825   $31,224 
               
    Other information:          
    Cash paid for operating cash flows for operating leases  $23,156   $22,482 
    Right-of-use assets obtained in exchange for new operating lease liabilities   —    — 
               
    Weighted-average remaining lease term - operating leases (year)   3.42    4.42 
    Weighted-average discount rate - operating leases   10.48%   10.48%

     

    Future non-cancelable minimum lease payments under the operating lease liability as of March 31, 2025, are as follows:

     Schedule of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability

    Years ended December 31,    
    2025 (excluding the three months ended March 31, 2025)  $71,090 
    2026   97,074 
    2027   99,986 
    2028   68,236 
    2029 and thereafter   — 
    Total future minimum lease payments   336,386 
    Less: imputed interest   (53,050)
    Present value of payments  $283,336 

     

    Note 4 – Notes Payable-Related Party

     

    On October 14, 2024, as part of the senior convertible note offering described in Note 5, the Company entered into a loan with an officer of the Company in the amount of $250,000 (principal) with an interest rate of 14.5% per annum due October 13, 2025, and warrants to purchase 100,382 shares of common stock at an exercise price of $1.40 per share. As of March 31, 2025, there was outstanding principal and interest balances for these related party notes of $250,000 and $7,653, respectively. Under the fair value option, the senior convertible note is $217,379 as of March 31, 2025.

     

    On September 4, 2024, the Company issued a $250,000 promissory note (the “Promissory Note”) to an officer of the Company for $250,000. The Promissory Note accrues interest at 12% per annum and is repayable in 12 substantially equal installments over a period of one year. During the three months ended March 31, 2025 the Company incurred $5,395 in interest expense relating to this Promissory Note. During the three months ended March 31, 2025 the Company repaid principal and interest of $61,540 and $5,097, respectively. The principal balance of the Promissory Note as of March 31, 2025 and December 31, 2024 was $128,730 and 190,270, respectively.

     

    Note 5 - Convertible Notes and Loan Agreement

     

    Revolving Note Agreement

     

    On February 27, 2025, the Company entered into a Revolving Loan Agreement with a lender. Pursuant to and under the terms of the Revolving Loan Agreement, the Company issued a revolving note dated February 28, 2025 in the principal amount of up to $2,000,000 (the “Revolving Note”), which the Company may draw upon at its discretion from time to time through its maturity on February 28, 2026.

     

    14

     

     

    The Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue interest daily commencing from the date of any draw down until paid in full on the maturity date. The Company recognized deferred loan costs of approximately $78,000 in relation to the closing of the Revolving Loan Agreement as an asset on the unaudited condensed consolidated balance sheet. These deferred loan costs are being amortized to interest expense on a straight-line basis to the maturity of the Revolving Loan Agreement. During the quarter ended March 31, 2025, the Company recognized $6,535 in interest expense related to the amortization of these deferred loan costs.

     

    The Revolving Loan Agreement contains customary events of default. If an event of default occurs, the lender may accelerate the repayment of amounts outstanding under the Revolving Loan Agreement, and an amount equal to 120% of the outstanding principal amount and accrued and unpaid interest plus other amounts, costs, expenses and/or liquidated damages. The default provision meets the criteria of a derivative liability that would have an associated fair value if any amounts are outstanding under the Agreement.

     

    As of March 31, 2025, the Company has not yet drawn on the Revolving Note and no balances are outstanding.

     

    2024 Convertible Bridge Notes

     

    During October 2024, the Company completed a senior convertible note offering in two closings, as further described below.

     

    On October 14, 2024, the Company issued an aggregate of $600,000 (of an up to $1.3 million authorized financing) senior secured convertible notes due in October 2025, which accrue interest at 14.5% interest per year. The notes include a 5% original issue discount and the Company received $570,000 in proceeds. The notes are optionally convertible by each holder at a 10% premium beginning three months after the date of issuance, and the conversion price will be the 5-day volume-weighted average price (“VWAP”) immediately prior to Closing unless re-set (one-time only) by a lower price of an offering entered into by the Company during the term of the notes. The Company has the option to prepay the notes at any time for 107% of total outstanding balance. Any outstanding principal at maturity will be paid in conversion of shares of common stock (provided such shares have been registered), at a 15% discount of the effective conversion price (unless re-set, one-time only), subject to the Company’s exercise of the optional prepayment right. If such shares of common stock have not been registered, any outstanding principal will be settled in cash. Any accrued interest will be repaid quarterly in cash. The Company also issued warrants to the lenders to purchase an aggregate 240,917 shares of common stock, exercisable at $1.40 per share, with such warrants expiring five years from issuance. In addition, the Company’s former Chief Executive Officer, now Chief Scientific Officer, Dr. Anatoly Dritschilo, invested a total of $237,500 in this financing round, in exchange for a $250,000 convertible note.

     

    As part of the same offering, on October 21, 2024, the Company issued an additional $231,579 in senior secured convertible notes due in October 2025, with substantially similar terms as the October 14, 2024, issuance. The notes include a 5% original issue discount and the Company received $220,000 in proceeds. The Company also issued warrants to the lenders to purchase an aggregate 88,544 shares of common stock, exercisable at $1.49 per share, with such warrants expiring five years from issuance. Upon completing this issuance, the Company closed the senior secured convertible note offering after receiving a total of $790,000 in proceeds.

     

    After analyzing the terms of the 2024 Convertible Bridge Notes (“Convertible Bridge Notes”) and its embedded features, the Company elected to account for the 2024 Convertible Bridge Notes at fair value under the allowable fair value option election. As such, the Company initially recognized the 2024 Convertible Bridge Notes at their fair value and subsequently measured the notes at fair value with changes in fair value recorded in current period earnings (or other comprehensive income, if specific to Company credit risk). The Company initially recorded the 2024 Convertible Bridge Notes at their estimated issuance date fair value of $806,758. As the fair value of the 2024 Convertible Bridge Notes exceeded the proceeds received, the Company recorded a loss on issuance of convertible notes of $16,758. The proceeds were allocated in full to the 2024 Convertible Bridge Notes recorded at fair value. The warrants issued in connection with the 2024 Convertible Bridge Notes were deemed to be equity instruments. In addition, the Company allocated the issuance costs incurred to these instruments to the 2024 Convertible Bridge Notes and, as such, expensed $107,491 in issuance costs, including $41,579 of original issue discount on the 2024 Convertible Bridge Notes.

     

    15

     

     

    The Company used a Monte Carlo simulation model to calculate the fair value of the 2024 Convertible Bridge Notes. The 2024 Convertible Bridge Notes were classified within Level 3 of the fair value hierarchy at the initial measurement date, due to the use of unobservable inputs. The key inputs into the model for the 2024 Convertible Bridge Note were as follows:

    Schedule of Key Inputs of Convertible Bridge Note

       March 31, 2025   December 31, 2024 
    Risk-free interest rate   4.38%   4.16%
    Expected term (years)   0.54    0.83 
    Quoted VWAP  $0.38   $0.82 
    Volatility   73.90% - 120.16%   57.50% - 97.14%
    Discount rate   40% - 60%   40% - 60%
    Probability assessment1   5% - 20%   10% - 40%
    Illiquidity discount   (29)%   (26)%

     

    (1)Probability assessments include the probabilities that subsequent successful capital raises (in terms of amounts raised and timing) are not executed and the probability that the securities issuable under the convertible bridge notes are not timely registered.

     

    The following table summarizes the changes in the carrying value of the 2024 Convertible Bridge Notes:

     

    Schedule of Fair Value Measurement using Significant Unobservable Inputs

          
    Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
    Balance - December 31, 2024  $684,205 
    Conversion of Convertible Bridge Note (at fair value)   (53,500)
    Payments of coupon interest   (31,056)
    Loss on change in fair value   92,479 
    Balance - March 31, 2025  $692,128 

     

    Alto Opportunity Master Fund, SPC

     

    On January 11, 2023, the Company entered into a securities purchase agreement (the “SPA”) with Alto Opportunity Master Fund, SPC – Segregated Master Portfolio B, a Cayman entity (the “Investor”), pursuant to which the Company sold to the Investor a $4,300,000 convertible note (the “Alto Convertible Note”) and warrant (the “Alto Warrant”) to purchase 127,260 shares of common stock, exercisable at $18.80 per share (after taking into account the Company’s August 2025 reverse stock split), in exchange for gross proceeds of $3,935,000 (the “Investment Amount”) (See Note 6). As a consequence of the Company issuing the Convertible Bridge Notes in October 2024, and then subsequently completing the Equity Financing in March 2025, the exercise price of the Alto Warrant was adjusted to $0.48 and $0.32 per share, respectively. The Company determined that the Alto Warrant contains a net cash settlement feature at inception and categorized the Alto Warrant as a liability in the accompanying consolidated financial statements. The Alto Convertible Note was amortized on a monthly basis and the Company could make such monthly amortization payments in cash or, subject to certain equity conditions, in registered shares of common stock or a combination thereof. Installments could be deferred by the noteholder, resulting in a variable interest rate. However, the effective interest rate was approximately 346% based on the internal rate of return calculated on a series of cash flows that occur at regular intervals. For equity repayment, the Alto Convertible Note was convertible into shares of common stock at a price per share equal to the lower of (i) $18.80 per share, as adjusted, (ii) 90% of the three lowest daily VWAPs of the 15 trading days prior to the payment date, or (iii) 90% of the VWAP of the trading day prior to payment date. The noteholder had an acceleration of installment amount conversion option (the “Alto Acceleration Option”), whereby the noteholder, with certain share percentage limitations, could convert to common stock any outstanding installment amount at an amount equal to the installment amount plus five times (5x) the installment amount at any time. The Company determined the Alto Acceleration Option was an embedded derivative within the host instrument and bifurcated it from the host instrument and recorded it as a derivative liability valued at $1,442,000 at inception, using a Monte Carlo simulation model (Note 7). The Convertible Note was repayable over 26 months and bore interest at the rate of 5% per annum. Additionally, the note contained certain redemption options and “Make Whole” provisions.

     

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    In conjunction with entry into the SPA, the Company entered into a series of related agreements, including a security agreement (the “Security Agreement”), an intellectual property security agreement (the “IP Security Agreement”) and a subsidiary guaranty (the “Subsidiary Guaranty”). The security agreements and guaranty allow, among other things, for the Investor to have a security interest in and place a lien on all of the Company’s assets and intellectual property until such time as the Alto Convertible Note is paid off. In addition, the SPA called for the Company to enter into a springing deposit account control agreement (the “Springing DACA”), which, in the event the Company defaulted on its repayment of the Alto Convertible Note, would allow the Investor to assume control of the Company’s bank account only with regard to any funds remaining outstanding under the Alto Convertible Note. As such, in conjunction with entry into the SPA, the Company established a separate bank account in which it deposited the Investment Amount and pursuant to which the Company, the Investor and the bank holding the Investment Amount, First Republic Bank, entered into the Springing DACA agreement. As the Investment Amount had been held at First Republic Bank, in light of certain banking crises then affecting smaller banks, on March 12, 2023, the Company and the Investor moved the Investment Amount from First Republic Bank, after which time the Springing DACA was no longer in effect. Further, pursuant to amendments to the SPA entered into in May and June of 2023, the Company and the Investor agreed that all of the Investment Amount would be released to the Company and the relevant provision of the SPA which required the Springing DACA would no longer be deemed applicable. In addition, the Company granted the Investor the option to purchase up to an additional $10 million in convertible notes and warrants on substantially the same terms as the Alto Convertible Note and Alto Warrant, excluding the Springing DACA requirement, with such option to be effective through December 31, 2025. The agreement offered the investor an opportunity to participate in future capital raises at substantially similar terms as the January 11, 2023 agreement. The Company expected that such subsequent convertible notes and warrants would be issued on substantially similar terms as the January 11, 2023 initial agreement, as amended, thus providing the Company the opportunity to negotiate certain aspects of the agreement.

     

    Boustead Securities, LLC (“Boustead”) served as a placement agent for the Alto Convertible Note and Warrant offering and received $345,000 cash compensation and a warrant to purchase 8,909 shares of common stock, exercisable at $18.80 per share. The Boustead warrant was determined to be an equity instrument valued on a non-recurring basis. The Company used the Black Scholes valuation model using a term of five years, volatility of 110%, a risk-free rate of 3.53% for a value of $99,543.

     

    The Company allocated the finance costs related to the Boustead placement agent fee of $345,000, based on the relative fair market values of the Convertible Note and warrants issued. The allocation of the financing costs applied $232,027 to the debt component as a debt discount that was being amortized to interest expense over the term of the Convertible Note, $104,245 to the warrant derivative liability component, expensed as a finance fee, and $8,727 to the equity warrant as a reduction in additional paid in capital.

     

    The Company allocated to the debt component of the note an original discount of $300,000, legal fees of $65,000, $215,000 for additional interest fees on day one added to note principal, $1,442,000 for the accelerated conversion feature, and $1,288,543 for the fair value of warrants, resulting in an additional $3,310,543 debt discount that was being amortized to interest expense over the term of the Alto Convertible Note.

     

    On August 6, 2024, the Company entered into an amendment to the SPA with Alto. Under the Amendment Agreement, the Company and Alto agreed as follows: (i) that the Company would pay $600,000 (the “Cash Collateral”) in cash by wire transfer of immediately available funds to Alto, which would be held as collateral on the remaining $1.2 million outstanding under the Alto Note; (ii) Alto will defer the monthly installment payment due on September 3, 2024 under the Alto Note until the Alto Note’s March 11, 2025 maturity date; and (iii) Alto would grant a waiver of any default Section 4(a)(xvi) of the Note related to the restatement and reaudit of the Company’s financial statements for the years ended December 31, 2022 and 2023. The amendment was accounted for as a troubled debt restructuring as the Company determined it was experiencing financial difficulties and was provided a concession through the deferral of one monthly principal and interest payment. As the future undiscounted cash flows exceeded the carrying value of the Alto Convertible Note, the Company did not recognize any gain or loss associated with the troubled debt restructuring.

     

    On February 26, 2025, the Company, entered into an amendment agreement (the “Amendment Agreement”) for purposes of amending the terms of the SPA originally dated January 11, 2023, and as amended May 10, 2023, June 5, 2023 and August 6, 2024, between the Company and Alto. Under the Amendment Agreement, in exchange for the Company’s payment of $75,000 to Alto, Alto agreed to permanently waive its right to purchase up to $10 million in Additional Notes and Additional Warrants and to a one-time waiver of the right to participate in the Company’s contemplated registered securities offering, as disclosed in the Company’s registration statement on Form S-1, filed with the SEC on February 13, 2025. The payment to Alto was accounted for as an issuance cost and recorded as a reduction to additional paid-in capital.

     

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    During the three months ended March 31, 2024, the Company recorded interest expense of $497,515, which included amortization of debt discount as interest expense of $445,509.

     

    During the three months ended March 31, 2024, the Company settled $235,200 of principal, and settled $18,783 of accrued interest, which settlements were made in the form of 78,197 shares of common stock, during the three months ended March 31, 2024. As a consequence of the settlement during the year ended December 31, 2024, no balances were outstanding as of March 31, 2025 and December 31, 2024.

     

    Note 6 - Stockholders’ Equity

     

    Common Stock

     

    During the three months ended March 31, 2025, the Company issued:

     

      ● 125,000 shares of common stock upon partial conversion of the 2024 Convertible Bridge Notes,
      ● 1,340,921 shares of common stock as part of a public offering, and
      ● 840,206 shares of common stock issued for vesting of restricted stock units.

     

    During the three months ended March 31, 2024, the Company issued:

     

      ● 78,197 shares of common stock to settle $235,200 of principal and $18,783 of interest on a convertible note and incurred $71,315 of loss on settlement, and
      ● 15,625 shares of common stock issued for vesting of restricted stock units.

     

    March 2025 Equity Financing

     

    On March 12, 2025, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with WestPark Capital, Inc. (“WestPark”) as the sole underwriter (the “Underwriter”), related to a public offering (the “Offering”) of (i) 1,340,921 shares of common stock, par value $0.00001 per share, of the Company, at a public offering price of $0.30 per share and (ii) pre-funded warrants to purchase 17,825,746 shares of Common Stock at an exercise price of $0.001 per share, at a public offering price of $0.299 per Pre-Funded Warrant (the “Pre-Funded Warrants”). The Offering closed on March 13, 2025.

     

    The Offering resulted in gross proceeds of approximately $5.7 million and net proceeds of approximately $5.0 million, reflecting approximately $0.7 million of legal costs and other expenses connected with the transaction.

     

    The Pre-Funded Warrants are exercisable at any time after March 13, 2025, at an exercise price of $0.001 per share. The Pre-Funded Warrants contain standard adjustments to the exercise price, including for stock splits, stock dividends and pro rata distributions and contain customary terms regarding the treatment of such Pre-Funded Warrants in the event of a fundamental transaction, which include but are not limited to a merger or consolidation involving the Company, a sale of all or substantially all of the assets of the Company or a business combination resulting in any person acquiring more than 50% of the outstanding shares of Common Stock of the Company. Additionally, the Pre-Funded Warrants include restrictions on exercise in the event the Purchaser’s beneficial ownership of the Company’s common stock would exceed 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise.

     

    The Company concluded that the Pre-Funded Warrants met the requirements to be classified in stockholders’ equity, and have been recorded as additional paid in capital.

     

    As of March 31, 2025, no Pre-Funded Warrants have expired or have been exercised.

     

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    Warrants

     

    In connection with the January 2023 Alto Convertible Note, Boustead was granted warrants to purchase 8,909 shares of common stock, at an exercise price of $18.80 per share (Note 5). In addition, Alto was granted warrants to purchase 127,260 shares of common stock, at an exercise price of $0.32 per share, as adjusted (Note 5, 7).

     

    In connection with the Convertible Bridge Notes issued on October 14, 2024, the lenders were granted warrants to purchase 240,917 shares of common stock, at an exercise price of $1.40 per share. In addition, in connection with the Convertible Bridge Notes issued on October 21, 2024, the lenders were granted warrants to purchase 88,544 shares of common stock, at an exercise price of $1.49 per share.

     

    In connection with the October 2024 Equity Financing, the Company issued pre-funded warrants to purchase up to 2,555,246 shares of common stock, at an exercise price of $0.001 per share, and warrants to purchase up to 2,950,820 shares of common stock, at an exercise price of $1.40 per share.

     

    The table below excludes the pre-funded warrants, of which none were exercised during the three months ended March 31, 2025. As of March 31, 2025, 19,651,746 pre-funded warrants remained unexercised and outstanding and have no expiration date, including 17,825,746 and 1,826,000 from the March 2025 and October 2024 Equity Financings, respectively.

     

    A summary of activity regarding warrants to purchase common stock (excluding pre-funded warrants) for the three months ended March 31, 2025 were as follows:

     Schedule of Warrants Activity

       Number of   Weighted Average   Average 
       warrants   Exercise Price   Life (years) 
    Outstanding, December 31, 2024  3,464,281   $1.89    4.67 
    Granted   —    —    0— 
    Outstanding, March 31, 2025   3,464,281   $1.88    4.42 

     

    The warrants had intrinsic value of $8,450 as of March 31, 2025. All of the outstanding warrants are exercisable as of March 31, 2025.

     

    Equity Incentive Plan

     

    The Company’s 2018 Equity Incentive Plan (the “2018 Plan”) provides for equity incentives to be granted to employees, executive officers, directors and key advisers and consultants. Equity incentive grants may be made in the form of stock options with an exercise price of not less than the fair market value of the underlying shares as determined pursuant to the 2018 Plan, restricted stock awards, other stock-based awards, or any combination of the foregoing. The 2018 Plan is administered by the Company’s compensation committee. The Company has reserved 3,000,000 shares of common stock for issuance under the 2018 Plan. As of March 31, 2025, 1,727,175 shares have been granted, net of forfeitures, under the 2018 Equity Incentive Plan, of which 930,250 shares have vested.

     

    Restricted Stock Units

     

    The Company may grant restricted stock units (“RSU”) under our 2018 Plan. RSUs are bookkeeping entries representing an amount equal to the fair market value of one share of our common stock. Subject to the provisions of the 2018 Plan, the administrator determines the terms and conditions of RSUs, including the vesting criteria and the form and timing of payment. Notwithstanding the foregoing, the administrator, in its sole discretion, may accelerate the time at which any restrictions will lapse or be removed. RSUs granted typically vest annually in one third increments from the date of appointment.

     

    During the three months ended March 31, 2025 and 2024, pursuant to agreements with directors, officers and consultants, 552,486 and 25,000 RSUs with a value of $0.3 million and $42 thousand were granted, respectively.

     

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    Stock-based compensation expense was classified as follows:

    Schedule of Compensation Expenses (RSUs)

       2025   2024 
       Three Months Ended 
       March 31, 
       2025   2024 
    Research and development  $320,105   $33,953 
    General and administrative   216,941    77,496 
    Total  $537,046   $111,449 

     

    On February 27, 2025, the Company entered into a Revolving Loan Agreement with Bowery Consulting Group Inc. (“Bowery”) where the Company may borrow from Bowery an aggregate principal amount of up to $2,000,000 (see Note 5). As part of one of the lender conditions, no less than four of the current board members were to resign, with three new nominees to be elected and appointed by the remaining members of the Company’s Board of Directors. Upon the resignation of the four board members, vesting of all outstanding unvested RSUs held by the departing board members were allowed to accelerate immediately. The Company concluded that the acceleration represented a modification of the outstanding unvested RSUs. As a result of the modification, the Company recorded approximately $0.5 million of stock based compensation expense.

     

    As of March 31, 2025, there was $0.5 million of unrecognized RSU compensation cost related to non-vested stock-based compensation arrangements which is expected to be recognized over a weighted-average period of 2.47 years.

     

    The following is a summary of activity regarding Restricted Stock Units issued:

     Schedule of Restricted Stock Units (RSUs)

       Number of RSU   Weighted Average Fair Value Per RSU 
    Outstanding, December 31, 2024   1,084,644   $0.84 
    Granted   552,486    0.54 
    Forfeited   —    — 
    Vested   (840,205)  $0.73 
    Outstanding, March 31, 2025  796,925   $0.74 

     

    Note 7 – Derivative Liabilities

     

    Fair Value Assumptions Used in Accounting for Derivative Liabilities

     

    ASC 815 requires the Company to assess the fair market value of derivative liabilities at the end of each reporting period and recognize any change in the fair market value as other income or expense.

     

    In October 2024, in connection with the Equity Financing, the Company issued warrants to purchase 2,950,820 shares of common stock, with an exercise price of $1.40 per share, valued at inception at $0.2 million and as of March 31, 2025, at less than $0.1 million. The Company determined that the derivative liabilities from the warrants issued in relation to the October 2024 Equity Financing did not qualify for classification as equity instruments as they did not meet the requirements to be considered indexed to the Company’s own stock, due to potential variability in the settlement amount upon a fundamental transaction, as defined.

     

    In January 2023, in connection with the Alto Convertible Note, the Company issued warrants to purchase 127,260 shares of common stock, with an exercise price of $0.32 per share, as adjusted, valued at inception at $1.1 million and as of March 31, 2025, at less than $0.1 million. The Company determined that the derivative liabilities from the warrants issued in relation to the Alto Convertible Note did not qualify for classification as equity instruments due to the existence of certain net cash settlement provisions that are not within the sole control of the Company. In addition, there are certain down round provisions that could reduce the exercise price if the Company issues securities at lower prices in the future.

     

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    The Company has determined the Acceleration Option in the Alto warrants is an embedded derivative within the host instrument and has bifurcated it from the host instrument and recorded it as a derivative liability valued at $1.4 million at inception, using a Monte Carlo simulation model. The Company determined its derivative liability from the noteholder’s Acceleration Option for the Alto Convertible Note was not clearly and closely related to the host and should thus be accounted for as a bifurcated derivative liability. As of March 31, 2025, the value of the Acceleration Option was $0 as the Alto Convertible Note was settled in full by September 30, 2024.

     

    The Company classifies these derivative liabilities as a Level 3 fair value measurement and used the Monte Carlo pricing model to calculate the fair value as of March 31, 2025 (less than $0.1 million) and December 31, 2024 (less than $0.1 million).

     

    The key inputs for the Monte Carlo simulation* for the Alto and October 2024 Equity Financing warrants as of March 31, 2025, were as follows:

     Schedule of Monte Carlo Simulation Assumption

    Net cash settlement and down round key valuation inputs - warrants*    
    Annualized volatility   73.90% - 120.16%
    Risk-free interest rate   3.89 - 4.38%
    Quoted VWAP  $0.38 
    Exercise price   0.32 - 1.40 
    Probability assessment1   5% - 20%
    Illiquidity discount   (29)%
    Time period (years)   1.79 - 4.58 

     

    1Probability assessments include the probabilities that subsequent successful capital raises (in terms of amounts raised and timing) are not executed and the probability that the securities issuable under the convertible bridge notes are not timely registered.

     

    *Based on a Monte Carlo simulation analysis of 50,000 iterations

     

    The key inputs for the Monte Carlo simulation as of December 31, 2024, were as follows:

     

    Net cash settlement and down round key valuation inputs - warrants*    
    Annualized volatility   57.50% - 97.14%
    Risk-free interest rate   4.25 - 4.38%
    Quoted VWAP  $0.82 
    Exercise price   0.48 - 1.40 
    Probability assessment1   10% - 40%
    Illiquidity discount   (26)%
    Time period (years)   2.03 - 4.84 

     

    1Probability assessments include the probabilities that subsequent successful capital raises (in terms of amounts raised and timing) are not executed and the probability that the securities issuable under the convertible bridge notes are not timely registered.

     

    *Based on a Monte Carlo simulation analysis of 50,000 iterations.

     

    The following table summarizes the changes in the derivative liabilities:

    Schedule of Derivative Liabilities 

    Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
       Warrants   Alto Acceleration Feature 
    Balance - December 31, 2024   $ 25,281     $ —  
    Addition of new derivatives     —       —  
    Gain on change in fair value     (2,643 )     —  
    Balance - March 31, 2025   $ 22,638     $ —  
                     
    Balance - December 31, 2023  $410,660   $3,852 
    Gain on change in fair value   (196,045)   (1,817)
    Addition of new derivatives   —    — 
    Balance - March 31, 2024  $214,615   $2,035 

     

    21

     

     

    Note 8 – Commitments and Contingencies

     

    On December 16, 2024, the Company entered into a sponsored research agreement (the “Sponsored Research Agreement”) with the Regents of the University of California, on behalf of its San Francisco campus (the “UCSF”), pursuant to which UCSF’s employees will conduct research on a project entitled “Investigation of 18F-fluorodeboronation method for PSMA targeting ligand radiolabeling and evaluation in prostate cancer models” (the “Research Program”). Under the terms of the Sponsored Research Agreement, the Company will bear the total cost of $0.3 million of the Research Program and has an exclusive license to the intellectual property underlying the research. This Sponsored Research Agreement will be effective for a period of one year and may be extended by written mutual consent of the parties. During the three months ended March 31, 2025, the Company made prepayments of $0.2 million and amortized $0.05 million of costs under the Sponsored Research Agreement.

     

    In January 2025, the Company entered into a change order to its existing agreement with Theradex Systems, Inc., the Company’s primary third-party CRO, for purposes of supporting the Company’s clinical trials of Ropidoxuridine. Following the change order, the Company’s total cost limit increased by $3.0 million, for an aggregate of $5.3 million, of which $3.2 million has not yet been incurred.

     

    In March 2025, the Company entered into a consulting services agreement (the “Consulting Agreement”) with Bowery Consulting Group Inc. (the “Consultant”). According to the Consulting Agreement, the Consultant will provide consulting services in connection with the Company’s business, advising on viability of plans for scaling activities, growth and capital raising strategies, and costs minimization associated with technological platform improvements and marketing spend. The Company agreed to pay the Consultant $260,000 for their services, of which the Company recognized less than $0.1 million during the three months ended March 31, 2025 related to the Consulting Agreement. The Company is not obligated to pay amounts under the Consulting Agreement until it regains full Nasdaq listing requirement.

     

    On November 10, 2021, the Company entered into an engagement agreement (“EA”) with Boustead designating Boustead as its exclusive financial advisor for corporate finance activities and subsequently, on August 29, 2022, the Company entered into an underwriting agreement with Boustead in conjunction with the Company’s IPO. The EA contained an up to three year right of first refusal (“ROFR’) and the Underwriting Agreement, which overrode conflicting terms in the EA, contained a two year ROFR following the September 2, 2022 closing of the Company’s IPO. Further, Boustead also had a ROFR in conjunction with the Company’s terminated rights offering, which provided Boutead with a ROFR through February 7, 2025. Following the Company’s engagement agreement and underwriting agreement with WestPark Capital dated February 10, 2025 and March 13, 2025, respectively, Boustead asserted it has ROFR rights, demanding termination of WestPark’s engagement and claiming entitlement to compensation under the Boustead EA. As of the reporting date, there are no conditions indicating a loss has been incurred, nor does the Company believe a loss is probable and reasonably estimable, therefore no accrual for a potential loss has been recorded.

     

    Note 9 – Business Segment Information

     

    The Company operates as one operating segment with a focus on products designed to address the limitations of current cancer therapies and extend new applications of radiation therapy. The CEO, as our chief operating decision maker (CODM), manages and allocates resources to the operations of the Company on a consolidated basis, considering primarily research and development expenditures, cash burn and net loss. This enables the CEO to assess our overall level of available resources and determine how best to deploy these resources across products and research and development projects in line with the longer-term Company-wide strategic goals. During the three months ended March 31, 2025, the Company appointed an Interim CEO, who assumed the role of CODM. This appointment did not result in any immediate changes to the reporting metrics that the CODM uses to manage and allocate resources to the operations of the Company. Our former CEO continues to chair the Company’s Board of Directors and serve in a corporate role as Chief Scientific Officer.

     

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    The accounting policies of our reportable segment are the same as those described in the “Summary of Significant Accounting Policies” for the Company. All costs, research and development expenses, general and administrative expenses, other operating expenses, interest expense, depreciation, corporate overhead assets (workforce, intellectual property, etc.) are fully allocated to the Company’s one segment. Significant segment expenses include payroll and costs incurred for the Company’s primary third-party contract research organization (“CRO”). During the three months ended March 31, 2025 and 2024, the Company incurred payroll expenses classified in our unaudited condensed consolidated statements of operations as research and development of $0.3 million and $0.3 million, respectively. During the three months ended March 31, 2025 and 2024, the Company incurred payroll expenses classified in our unaudited condensed consolidated statements of operations as general and administrative of $0.2 million and $0.1 million. During the three months ended March 31, 2025, the Company incurred third-party CRO expenses of $0.8 million and $0.2 million, respectively, all of which is classified in our unaudited condensed consolidated statements of operations as research and development. All other operating expenses in our unaudited condensed consolidated statements of operations are characterized as other segment expenses which, after factoring in other income and expenses, reconcile to net loss for each period. The Company’s reportable segment’s profit or loss, assets, significant expenses and other specified items are consistent with the financial information disclosed in our unaudited condensed consolidated financial statements. See the unaudited condensed consolidated financial statements for the financial information of the Company’s one segment.

     

    Note 10 – Subsequent Events

     

    On April 3, 2025, the Company, entered into a consulting agreement (the “Consulting Agreement”) with IR Agency LLC (the “IR Agency”). Pursuant to the Consulting Agreement, IR Agency agrees to provide certain marketing and advertising services to communicate information about the Company to the financial community (the “Services”), including, but not limited to, creating company profiles, media distribution and building a digital community with respect to the Company. As consideration for the performance of the Services, the Company paid IR Agency $2.0 million on April 5, 2025. The term of the Consulting Agreement will be three months starting on April 3, 2025.

     

    On April 4, 2025, the Company received a conversion request related to the Convertible Bridge Notes. As a result, the Company issued 175,000 shares of common stock with a fair value of $77,525.

     

    Through May 8, 2025, holders exercised prefunded warrants, resulting in the issuance of 4,426,000 shares of common stock.

     

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    ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     

    The following Management’s Discussion and Analysis of Financial Condition and Result of Operations (the “MD&A”) should be read in conjunction with our unaudited financial statements and the related notes thereto included elsewhere in this Quarterly Report and our financial statement and related notes contained in our annual report on Form 10-K for the fiscal year ended December 31, 2024. The MD&A contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect,” and the like, and/or future-tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify certain of these forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements in this report. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, those noted under “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2024.

     

    We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this report, except as required by U.S. federal securities laws.

     

    Overview

     

    Founded by Georgetown University Medical School faculty members, Shuttle Pharmaceuticals Holdings, Inc. is a discovery and development stage pharmaceutical company leveraging our proprietary technology to develop novel therapies that are designed to cure cancer. Originally formed as Shuttle Pharmaceuticals, LLC in 2012, our goal is to extend the benefits of cancer treatments by leveraging insights into cancer therapy with surgery, radiation therapy, chemotherapy and immunotherapy. While there are several therapies being developed with the goal of curing cancer, one of the most effective and proven approaches to this is radiation therapy (“RT”). We are developing a pipeline of products designed to address the limitations of the current standard of cancer therapies. We believe that our product candidates will enable us to deliver cancer treatments that are safer, more reliable and at a greater scale than that of the current standard of care.

     

    Operations to date have focused on continuing our research and development efforts to advance Ropidoxuridine clinical testing and improved drug formulation, to advance HDAC6 inhibitor (SP-2-225) preclinical development and explore the application of the PC-RAD Test, predictive biomarkers of radiation response. The clinical development of Ropidoxuridine has included completion of a Phase I clinical trial to establish drug bioavailability and a maximum tolerated dose for use in Phase II clinical trials. TCG GreenChem, with whom we have contracted for process research, development and cGMP compliant manufacture of IPdR, has manufactured the API of Ropidoxuridine and the University of Iowa Pharmaceuticals has formulated the drug product for use in our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy. The drug product (capsules) were shipped to CRO Theradex Oncology and distributed to clinical trial sites that are fully approved to enroll patients in the trial. Shuttle received approval from the FDA to begin the clinical trial. The FDA thereafter made recommendations to expand the clinical trial to include a randomized dose “optimization” step and we agreed with the recommendation. Meetings with engaged clinical sites to review the protocol documents have occurred and FDA required IRB approvals have been received. With FDA recommended changes incorporated into the revised protocol and the completion of site initiation visits, we commenced our Phase II clinical study in October 2024. The Company’s radiation biomarker project and the health disparities project have been completed and we are proceeding with plans for clinical validation and potential for commercialization of Ropidoxuridine as a radiation sensitizer.

     

    Nasdaq Listing Compliance

     

    On December 31, 2024, we received a letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) stating that for the 30 consecutive business day period between November 15, 2024 to December 30, 2024 our common stock had failed to maintain a minimum closing bid price of $1.00 per share, as required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days, or until June 30, 2025 (the “Compliance Period”), to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days.

     

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    Because we have already completed a 1-for-8 reverse stock split in August 2024, under new Nasdaq rules, we will not be allowed an additional 180 day compliance period. As such, if we do not regain compliance with the Minimum Bid Price Requirement by June 30, 2025, we will be subject to delisting. As such, we are seeking stockholder approval to complete an additional reverse stock split at our upcoming Annual Meeting of Stockholders, scheduled to be held on May 9, 2025, in the event our stock does not begin trading above $1.00 per share in the interim.

     

    If we cannot regain compliance during the Compliance Period, by reverse split or otherwise, Nasdaq will provide a notice that our common stock will be subject to delisting. At that time, we may appeal Nasdaq’s delisting determination to a Nasdaq Hearings Panel.

     

    Nasdaq’s notice of noncompliance has no immediate effect on the listing of our common stock and our common stock will continue to be listed on The Nasdaq Capital Market under the symbol “SHPH.” There can be no assurance that we will regain compliance with the Minimum Bid Price Requirement or maintain compliance with any of the other Nasdaq continued listing requirements. We will continue to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement.

     

    On September 10, 2024, we received a letter from Nasdaq, notifying us that we were no longer in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million. In our Quarterly Report on Form 10-Q for the period ended June 30, 2024, we reported stockholders’ equity of $0.8 million, which was below the minimum stockholders’ equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). Nasdaq provided us with 45 calendar days, or until October 25, 2024, to submit a plan to regain compliance with the minimum stockholders’ equity standard. On October 15, 2024, we submitted a plan to Nasdaq to regain compliance and Nasdaq subsequently granted us up until March 10, 2025 to regain compliance.

     

    Following the Company’s March 2025 $5.75 million equity financing, on March 14, 2025, Nasdaq acknowledged that we had regained compliance with the Listing Rule 5550(b)(1) but indicated that if we fail to evidence compliance upon filing our next periodic report for the period ended March 31, 2025, we may be subject to delisting. As evidenced herein, we continue to be in compliance with the Listing Rule 5550(b)(1). However, Nasdaq will continue to monitor our ongoing compliance with the Minimum Equity Requirement and, subject to a determination that we are not in compliance, we may be subject to delisting.

     

    Results of Operations

     

    Comparison of the three months ended March 31, 2025 and 2024

     

    The following table summarizes the results of our operations:

     

       Three Months Ended         
       March 31,         
       2025   2024   Change   % 
    Revenue  $—   $—   $—    — 
    Operating expenses:                    
    Research and development   1,573,928    586,104    987,824    169%
    General and administrative   596,886    324,609    272,277    84%
    Legal and professional   780,427    474,134    306,293    65%
    Total operating expenses and loss of operations   2,951,241    1,384,847    1,566,394    113%
                         
    Other income (expense):                    
    Interest expense - related parties   (5,395)   —    (5,395)   —%
    Interest expense   (6,535)   (497,515)   490,980    (99)%
    Interest income   —    21,453    (21,453)   (100)%
    Change in fair value of derivative liabilities   2,643    197,862    (195,219)   (99)%
    Change in fair value of convertible notes   (92,479)   —    (92,479)   —%
    Gain on sale of marketable securities   —    4,037    (4,037)   (100)%
    Change in fair value of marketable securities   —    (706)   706    (100)%
    Loss on settlement of convertible debt   —    (71,315)   71,315    (100)%
    Total other expense   (101,766)   (346,184)   244,418    (71)%
    Net loss  $(3,053,007)  $(1,731,031)  $(1,321,976)   76%

     

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    Research and Development. Total research and development (“R&D”) expense was $1.6 million for the three months ended March 31, 2025, as compared to $0.6 million to the three months ended March 31, 2024. The increase in total R&D expense of $1.0 million, or 169%, is primarily related to the Company having completed production of the drug product and the start of work related to the initiation of trials including contract research organization (“CRO”) expenses, clinical trial sites, other regulatory activities.

     

    R&D compensation related expenses were $0.6 million in the three months ended March 31, 2025 as compared to $0.3 million in the three months ended March 31, 2024. For the three months ended March 31, 2025, R&D compensation related expenses were 39% as a percent of total R&D expense, representing a decrease from the 56% of total R&D incurred in the three months ended March 31, 2024. Subcontractor expense made up 58% of total R&D expenses in the three months ended March 31, 2025 and 34% of total R&D expenses during the three months ended March 31, 2024.

     

    General and Administrative Expenses. General and administrative expenses in the three months ended March 31, 2025 increased by $0.3 million, or 84%, from $0.3 million in the three months ended March 31, 2024 to $0.6 million in the three months ended March 31, 2025. The increase in general and administrative expenses was primarily due to costs associated with stock-based compensation of $0.1 million and marketing of $0.1 million for investor relations and other administrative costs.

     

    Legal and Professional Expenses. During the three months ended March 31, 2025, legal and professional expenses increased by $0.3 million or 65% compared to the same period in 2024. The increase in legal and professional fees was primarily due to increases in legal costs associated with corporate matters and our accounting expenses related to our public filing requirements.

     

    Other Income (expense). During the three months ended March 31, 2025, other expense decreased by $0.3 million or 73% compared to the same period in 2024. The decrease was primarily driven by a $0.5 million decrease in interest expense. The decrease was partially offset by a $0.2 million decrease in change in fair value of derivative liabilities.

     

    Liquidity and Capital Resources

     

    Our unaudited condensed consolidated financial statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have incurred losses since inception and had a net loss of $3.0 million and no revenues generated during the three months ended March 31, 2025 and working capital of approximately $3.2 million as of March 31, 2025. We do not expect to generate positive cash flows from operating activities in the near future.

     

    In January 2025, we entered into a change order to the existing agreement with Theradex Systems, Inc., our primary third-party CRO, for purposes of supporting our clinical trials of Ropidoxuridine. Following the change order, our total cost limit increased by $3.0 million, for an aggregate of $5.3 million, of which $2.4 million had not yet been incurred as of March 31, 2025.

     

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    In March 2025, we entered into a consulting services agreement (the “Bowery Consulting Agreement”) with Bowery Consulting Group Inc. (the “Consultant”). According to the Bowery Consulting Agreement, the Consultant will provide consulting services in connection with our business, advising on viability of plans for scaling activities, growth and capital raising strategies and cost minimization associated with technological platform improvements and marketing spend. We agreed to pay the Consultant $260,000 for their services. We are not obligated to pay amounts under the Bowery Consulting Agreement until we regain full Nasdaq listing requirement compliance.

     

    In April 2025, we entered into a consulting agreement (the “IR Agency Consulting Agreement”) with IR Agency LLC (the “IR Agency”). Pursuant to the IR Agency Consulting Agreement, IR Agency agrees to provide certain marketing and advertising services to communicate information about us to the financial community (the “Services”), including, but not limited to, creating company profiles, media distribution and building a digital community with respect to us. As consideration for the performance of the Services, we paid IR Agency $2.0 million on April 5, 2025. The term of the IR Agency Consulting Agreement is three months commencing April 3, 2025.

     

    Our ability to continue as a going concern is dependent upon our ability to continue to successfully raise additional equity or debt financing to allow us to fund ongoing operations, conduct clinical trials and bring a drug candidate to commercialization to generate revenues. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements contained in this report are issued.

     

    Recent Financings

     

    On February 27, 2025, we entered into a Revolving Loan Agreement (the “Revolving Loan Agreement”) with certain lender identified on the signature page thereto. Pursuant to and under the terms of the Revolving Loan Agreement, we issued a revolving note dated February 28, 2025 in the principal amount of up to $2.0 million (the “Revolving Note”), which we may draw upon at our discretion from time to time through its maturity on February 28, 2026. The Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue interest daily commencing from the date of any draw down until paid in full.

     

    On March 12, 2025, we consummated a public offering of an aggregate of (i) 1,340,921 shares of common stock, of the Company, at a public offering price of $0.30 per share and (ii) pre-funded warrants to purchase 17,825,746 shares of common stock at an exercise price of $0.001 per share, at a public offering price of $0.299 per pre-funded warrant (the “Offering”). The Offering closed on March 13, 2025. We received gross proceeds of approximately $5.7 million and net proceeds of approximately $5.0 million, reflecting approximately $0.7 million of legal costs and other expenses connected with the Offering.

     

    Balance Sheet Data:

       March 31,   December 31,         
       2025   2024   Change   % 
    Current assets  $4,959,397   $2,210,917   $2,748,480    124%
    Current liabilities   1,782,177    1,533,769    248,408    16%
    Working capital  $3,177,220   $677,148   $2,500,072    369%

     

    As of March 31, 2025, total current assets were $5.0 million and total current liabilities were $1.8 million, resulting in working capital of $3.2 million. As of December 31, 2024, total current assets were $2.2 million and total current liabilities were $1.5 million, resulting in a working capital of $0.7 million. The Company’s current assets as of March 31, 2025 are comprised of $4.5 million of cash and cash equivalents and $0.4 million of prepaid expenses, with the increase from December 31, 2024 being primarily due to the March 2025 equity raise that provided $5.0 million in net cash.

     

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    In addition, we continued progress on our R&D programs during the three months ended March 31, 2025 that resulted in increased cash expenditures. The Company’s current liabilities as of March 31, 2025 are primarily comprised of $0.7 million of convertible notes payable, $0.9 million of accounts payable and accrued expenses, $0.1 million of notes payable to related parties, and the current portion of our operating lease liability of $0.1 million. The increase in current liabilities is primarily due to an increases in accounts payable and accrued expenses of $0.2 million, primarily attributable to our efforts to preserve cash while we strive to raise funds to finance ongoing business and operations.

     

    Cash Flows

       Three Months Ended         
       March 31,   Change   % 
       2025   2024         
    Cash used in operating activities  $(2,526,924)  $(1,239,083)  $(1,287,841)   104%
    Cash provided by investing activities  $—   $101,295   $(101,295)   100%
    Cash provided by (used in) financing activities  $5,119,387   $(40,000)  $5,159,387    (12898)%
    Cash and cash equivalents on hand  $4,512,607   $1,398,628   $3,113,979    223%

     

    Cash Flows from Operating Activities

     

    Our cash flows from operating activities are greatly influenced by our use of cash for operating expenses and working capital requirements to support the business. We have historically experienced negative cash flows from operating activities as we invested in research and development activities. The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges, which are generally attributable to stock-based compensation, changes in fair value of our derivative liabilities and amortization of debt discounts and finance fees, as well as changes in components of operating assets and liabilities, which are generally attributable to increased expenses and timing of vendor payments.

     

    During the three months ended March 31, 2025, net cash used in operating activities of $2.5 million was primarily due to our net loss of $3.0 million, stock-based compensation of $0.5 million, change in fair value of convertible notes of $0.1 million, partially offset by the net change in operating assets and liabilities of $0.1 million.

     

    During the three months ended March 31, 2024, net cash used in operating activities of $1.2 million was primarily due to our net loss of $1.7 million, increased by a gain on change in derivative liabilities of $0.2 million, offset by amortization of debt discount of $0.4 million, loss on settlement of convertible debt of less than $0.1 million, accrued interest settled with common stock of less than $0.1 million, stock-based compensation of $0.1 million and increased by a net change in working capital of $0.1 million.

     

    Cash Flows from Investing Activities

     

    For the three months ended March 31, 2025, the Company did not have investing activities. For the three months ended March 31, 2024, cash flows used in investing activities was primarily attributable to investing in trading marketable securities for $19 thousand and receiving $120 thousand in proceeds from disposition of marketable securities.

     

    Cash Flows from Financing Activities

     

    For the three months ended March 31, 2025, cash flows from financing activities was primarily comprised of net proceeds of $5.4 million, from the sale of common stock and pre-funded warrants, net of placement agent costs of $0.3 million, partially offset by $0.2 million payment of other issuance costs for issuance of common stock and equity-classified warrants, $0.1 million of payment for finance cost, and $0.1 million of repayment of note payable-related party used to finance the Company’s ongoing operations. For the three months ended March 31, 2024, the Company paid $40,000 related to financing activities.

     

    Off-Balance Sheet Arrangements

     

    We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

     

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    Critical Accounting Policies and Significant Judgments and Estimates

     

    This discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While the significant accounting policies are described in more detail in the notes to the unaudited condensed consolidated financial statements included elsewhere in this report, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

     

    Our most critical accounting policies and estimates relate to the following:

     

      ● Research and Development Expenses
      ● Fair Value of Convertible Notes
      ● Fair Value of Warrant to Purchase Common Stock
      ● Fair Value of Derivative Financial Instruments

     

    Research and Development Expense

     

    Research and development expenses are expensed as incurred and, prior to our initial public offering in September 2022, have historically been offset by contract receivable payments from an NIH SBIR contract that has supported our scientific research. This is stated in the financials as research and development-net of contract expense reimbursements.

     

    Fair Value of Convertible Notes

     

    As permitted under ASC 825, Financial Instruments (“ASC 825”), we elected the fair value option to account for the October 2024 Convertible Bridge Notes. The valuation of the October 2024 Convertible Bridge Notes utilizes a Monte Carlo simulation model. Monte Carlo simulation models require the use of simulations that are weighted based on projected future stock prices, the volatility of a set of guideline companies and significant unobservable inputs including probabilities assigned to not achieving a successful capital raise and a registration of related securities. Each simulation is based on the range of inputs in a scenario with the mean of the output on each simulation calculated as an average.

     

    The significant inputs and assumptions used to estimate the fair value also include: (i) the expected timing of conversion, (ii) the amount subject to equity conversion, (iii) the sum of the notes’ principal and unpaid accrued interest, (iv) expected volatility, (v) risk-free interest rate, (vi) the discount rate, (vii) volume-weighted average price (“VWAP”), (viii) illiquidity discounts, and (ix) probabilities assigned. The October 2024 Convertible Bridge Notes are subject to revaluation at the end of each reporting period, with changes in fair value recognized in the accompanying unaudited condensed consolidated statements of operations, or for changes due to our credit worthiness, if any, as a component of other comprehensive income.

     

    Fair Value of Warrants to Purchase Common Stock

     

    We have issued warrants to investors in our debt and equity offerings. We have also issued warrants to service providers in relation to our financing offerings.

     

    We evaluate all warrants issued to determine the appropriate classification under ASC 480 and ASC 815 (as well as under ASC 718 for warrants issued as share-based payments). In addition to determining classification, we evaluate these instruments to determine if such instruments meet the definition of a derivative.

     

    For warrants that are determined to be equity-classified, we estimate the fair value at issuance and record the amounts to additional paid in capital (potentially on a relative fair value basis if issued in a basket transaction with other financial instruments). Warrants that are equity-classified are not subsequently remeasured unless modified or required to be reclassified as liabilities. For warrants that are determined to be liability-classified, we estimate the fair value at issuance and each subsequent reporting date, with changes in the fair value reported in the unaudited condensed consolidated statements of operations. The classification of all outstanding warrants, including whether such instruments should be recorded as equity, is evaluated at the end of each reporting period.

     

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    For warrants with uncertain or more complex terms (such as variability in the warrant shares or exercise price), we may utilize more complex models to address such provisions, including Monte Carlo simulation models. Monte Carlo simulation models require the use of simulations that are weighted based on projected future stock prices, the volatility of a set of guideline companies and significant unobservable inputs including probabilities assigned. Each simulation is based on the range of inputs in a scenario with the mean of the output on each simulation calculated as an average.

     

    The use of these valuation models requires the input of highly subjective assumptions. Any change to these inputs could produce significantly higher or lower fair value measurements.

     

    Fair Value of Financial Instruments

     

    We evaluate our financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, such as the Acceleration Option in the Alto warrants (as defined in Note 5). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the unaudited condensed consolidated statements of operations. The classification of derivative instruments, including whether such instruments should be recorded as liabilities are evaluated at the end of each reporting period.

     

    For our derivative financial instruments classified as a liability, we use a Monte Carlo valuation model to value the derivative instruments at inception and on subsequent valuation dates. The model requires the use of simulations that are weighted based the volatility of a set of guideline companies and significant unobservable inputs including probabilities assigned. Each simulation is based on the range of inputs in a scenario with the mean of the output on each simulation calculated as an average. The Monte Carlo simulation uses an implied VWAP for valuation. The implied VWAP was backsolved by setting the summation of the parts (e.g., derivatives and debt without derivatives) equal to the cash proceeds and is updated each period.

     

    The use of Monte Carlo valuation models require key inputs, some of which are based on estimates and judgements by management. Any change to these key inputs could produce significantly higher or lower fair value measurements.

     

    Item 3. Quantitative and Qualitative Disclosures About Market Risk

     

    As a “smaller reporting company,” we are not required to provide the information required by this Item.

     

    Item 4. Controls and Procedures

     

    Evaluation of Disclosure Controls and Procedures

     

    Disclosure controls and procedures (as defined in Securities Exchange Act of 1934, as amended, or the Exchange Act Rule 15d-15(e)) are designed with the objective of ensuring that information required to be disclosed in our reports filed under the Exchange Act, such as this report, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures are also designed with the objective of ensuring that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

     

    As of March 31, 2025, our management carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures. Such evaluation was carried out under the supervision of our Chief Executive Officer with the participation of our President and Chief Operating Officer, and our Chief Financial Officer, and our third-party financial service provider. Based on this evaluation, management concluded that our disclosure controls and procedures were, and continue to be, ineffective as of March 31, 2025. Based on the foregoing, our management concluded that our internal controls over the following financial reporting areas to be material weaknesses:

     

      ● Our written policies and procedures over accounting transaction processing and period end financial close and reporting are limited, which has resulted in ineffective oversight in the establishment of proper monitoring controls over accounting and financial reporting; in addition, we lacked sufficient review and segregation of duties for certain financial transactions, manual journal entries, and critical financial spreadsheets, such that a proper review had not been performed by someone other than preparer, and that process documentation is lacking for review and monitoring controls over accounting and financial reporting. These were contributing factors which led to untimely filings for certain periods in fiscal year 2024.

     

    30

     

     

      ● We lack a formal process to identify and ensure the proper classification of operating expenses as Research and Development.
      ● We identified findings related to overall information technology general controls (“ITGCs”) including issues with super-user access and segregation of duties for systems supporting the Company’s internal control processes and controls.

     

    Management’s Remediation Measures

     

    While the Company has improved its organizational capabilities, the Company’s remediation efforts will continue to take place. Management is committed to maintaining a strong internal control environment. In response to the identified material weaknesses in the overall control environment, management is currently implementing additional measures which include:

     

    ● Hired a new Chief Financial Officer during the second quarter of 2024 to bolster the Company’s internal technical accounting and financial reporting experience and provide bandwidth for the prior Chief Financial Officer to focus on the Company’s expanding clinical trial.
       
    ● Engaged a third-party consulting firm to assist with the preparation of SEC reporting and other technical accounting matters.

     

    The Company will continue to review and improve its internal controls over financial reporting to address the underlying causes of the material weaknesses and control deficiencies. Such material weaknesses and control deficiencies will not be fully remediated until the Company has concluded that its internal controls are operating effectively for a sufficient period of time.

     

    Remediation of Previously Disclosed Material Weaknesses

     

    As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, we identified material weaknesses in our internal controls over financial reporting for 1) significant unusual transactions, including complex accounting associated with debt and equity transactions and 2) certain technical aspects of financial reporting for stock-based compensation transactions. Our remediation efforts, including those noted above, were completed and the related controls were in place for a sufficient period of time to conclude that these material weaknesses were remediated as of March 31, 2025.

     

    Changes in Internal Control over Financial Reporting

     

    There has been no change in the Company’s internal control over financial reporting during the three months ended March 31, 2025 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. Management will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional improvements as necessary.

     

    31

     

     

    PART II — OTHER INFORMATION

     

    ITEM 1. LEGAL PROCEEDINGS

     

    Currently, there are no legal proceedings pending or threatened against us. We are not presently party to any pending or other threatened legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results, although from time to time, we may become involved in legal proceedings in the ordinary course of business.

     

    ITEM 1A. RISK FACTORS

     

    As a smaller reporting company, we are not required to provide the information required by this item.

     

    ITEM 2. UNREGISTERED SALES OF SECURITIES AND USE OF PROCEEDS

     

    None.

     

    ITEM 3. DEFAULTS UPON SENIOR SECURITIES

     

    Not Applicable.

     

    ITEM 4. MINE SAFETY DISCLOSURES

     

    Not Applicable.

     

    ITEM 5. OTHER INFORMATION

     

    During the quarter ended March 31, 2025, none of our directors or executive officers adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as each item is defined Item 408(a) of Regulation S-K).

     

    Item 6. Exhibits

     

    The following exhibits are filed or furnished with this report:

     

    Exhibit No.   Description of Exhibit
    10.1   Form of Pre-Funded Warrants (incorporated by reference to Exhibit 4.9 to the Registration Statement on Form S-1/A (File No. 333-284889) filed on March 5, 2025).
    10.2   Amendment Agreement, dated February 26, 2025, between Shuttle Pharmaceuticals Holdings, Inc. and Alto Opportunity Master Fund, SPC – Segregated Master Portfolio B (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed February 27, 2025).
    10.3   Revolving Loan Agreement, dated February 28, 2025, between Shuttle Pharmaceuticals Holdings, Inc. and Bowery Consulting Group Inc. (incorporated by reference to the Current Report on Form 8-K filed on February 28, 2025).
    10.4   Revolving Note, dated February 28, 2025, between Shuttle Pharmaceuticals Holdings, Inc. and Bowery Consulting Group Inc. (incorporated by reference to Current Report on Form 8-K filed on February 28, 2025).
    10.5   Employment Agreement, dated March 11, 2025, between Shuttle Pharmaceuticals Holdings, Inc. and Christopher Cooper (incorporated by reference to Exhibit 10. 1 to the Current Report on Form 8-K filed on March 12, 2025).
    10.6   Form of Employment Agreement, dated March 31, 2025, between Shuttle Pharmaceuticals holdings, Inc. and Anatoly Dritschilo (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 31, 2025).
    31.1   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
    31.2   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
    32.1   Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
    32.2   Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
    101.INS   Inline XBRL Document Set for the financial statements and accompanying notes in Part I, Item 1, of this Quarterly Report on Form 10-Q.
    104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    * Filed herewith.

    **Furnished herewith.

     

    32

     

     

    SIGNATURES

     

    In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

     

      SHUTTLE PHARMACEUTICALS HOLDINGS, INC.
         
    May 8, 2025 By: /s/ Chris Cooper
        Chris Cooper
        Interim Chief Executive Officer
        (Principal Executive Officer)
         
    May 8, 2025 By: /s/ Timothy J. Lorber
       

    Timothy J. Lorber

    Chief Financial Officer

        (Principal Financial and Accounting Officer)

     

    33

     

     

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