SHPH 10-Q/A
Shuttle Pharmaceuticals Holdings, Inc. (SHPH)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Amendment No. 1)
(Mark One)
| Quarterly Report UNDER Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the quarterly period ended
OR
| Transition Report UNDER Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from ______________ to ______________
Commission
file number
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification Number) |
(Address of principal executive offices) (Zip Code)
(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 | ||
| The
|
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.
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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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 | ☐ | |
| ☒ | 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 if 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 September 3, 2024 was .
EXPLANATORY NOTE
Various changes were made to the Original Filing by the Company after being reviewed by its current audit firm, Forvis Mazars LLP, including changes to the condensed consolidated balance sheet and statement of operations.
The Company’s Principal Executive Officer and Principal Financial Officer has provided new certifications dated as of the date of this filing in connection with this Amendment No.1 (Exhibits 31.1, 31.2, 32.1 and 32.2).
In addition, prior to our completion of this Amendment No. 1, on August 13, 2024, the Company effected a 1-for-8 reverse split of our issued and outstanding common stock in order to regain compliance with Nasdaq Listing Rule 5550(a)(2), the minimum bid price requirement. As a result, all issued share numbers and per share prices reflected in this 10-Q/A are on a post-reverse split basis, unless otherwise indicated.
Shuttle Pharmaceuticals Holdings, Inc.
TABLE OF CONTENTS
| i |
PART I. Financial Information
Item 1. Unaudited Condensed Consolidated Financial Statements
Shuttle Pharmaceuticals Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| March 31, | December 31, | |||||||
2024 (as restated) | 2023 (as restated) | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Marketable securities | ||||||||
| Accrued interest income | ||||||||
| Other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use asset | ||||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Accounts payable and accrued expenses related party | ||||||||
| Accrued interest payable | ||||||||
| Convertible notes payable, net | ||||||||
| Derivative liability | ||||||||
| Operating lease liability | ||||||||
| Total Current Liabilities | ||||||||
| Convertible notes payable non-current, net | ||||||||
| Derivative liabilities non-current | ||||||||
| Operating lease liability non-current | ||||||||
| Total Liabilities | ||||||||
| Stockholders’ Equity | ||||||||
| Series A Convertible Preferred Stock, $ par value; $ | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding, respectively | ||||||||
| Additional paid in capital, as restated | ||||||||
| Accumulated deficit, as restated | ( | ) | ( | ) | ||||
| Total Stockholders’ Equity | ||||||||
| Total Liabilities and Stockholders’ Equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 1 |
Shuttle Pharmaceuticals Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | $ | ||||||
| Operating expenses | ||||||||
| Research and development | ||||||||
| General and administrative | ||||||||
| Legal and professional | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( |
) | ( |
) | ||||
| Other income (expense) | ||||||||
| Interest expense - related parties | ( |
) | ||||||
| Interest expense | ( |
) | ( |
) | ||||
| Interest income | ||||||||
| Finance fee | ( |
) | ||||||
| Change in fair value of derivative liabilities | ||||||||
| Gain on sale of marketable securities | ||||||||
| Change in fair value of marketable securities | ( |
) | ||||||
| Loss on settlement of convertible debt | ( |
) | ( |
) | ||||
| Total other income (expense) | ( |
) | ||||||
| Net loss attributable to common stockholders | $ | ( |
) | $ | ( |
) | ||
| Weighted average common shares outstanding - basic and diluted | ||||||||
| Net loss per shares - basic and diluted | $ | ) | $ | ) | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 2 |
Shuttle Pharmaceuticals Holdings, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
(Unaudited)
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 (as restated) | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Common stock issued for conversion of accrued interest and principal | $ | |||||||||||||||||||
| Common stock issued for restricted stock units | $ | |||||||||||||||||||
| Stock-based compensation | — | $ | ||||||||||||||||||
| Net loss | — | ( | ) | $ | ( | ) | ||||||||||||||
| Balance at March 31, 2024 (as restated) | $ | $ | $ | ( | ) | $ | ||||||||||||||
For the Three Months Ended March 31, 2023
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||
| Balance - December 31, 2022 (as restated) | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Warrants issued for financing costs | — | |||||||||||||||||||
| Common stock issued for conversion of accrued interest and principal | ||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance - March 31, 2023 (as restated) | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 3 |
Shuttle Pharmaceuticals Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Change in fair value of derivative liability | ( | ) | ( | ) | ||||
| Amortization of debt discount and finance fees | ||||||||
| Gain on marketable securities | ( | ) | ||||||
| Change in fair value of marketable securities | ( | ) | ||||||
| Accrued interest settled with common stock | ||||||||
| Loss on settlement of convertible debt | ||||||||
| Stock-based compensation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accrued interest income | ( | ) | ||||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Accounts payable and accrued expenses | ||||||||
| Accounts payable and accrued expenses - related parties | ( | ) | ( | ) | ||||
| Accrued interest payable | ||||||||
| Accrued interest payable - related parties | ( | ) | ||||||
| Other assets | ( | ) | ||||||
| Change in operating lease asset and liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Investment in marketable securities | ( | ) | ( | ) | ||||
| Proceeds from disposition of marketable securities | ||||||||
| Net cash used in investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Repayment of note payable-related party | ( | ) | ||||||
| Proceeds from convertible notes payable and warrants | ||||||||
| Payment for finance costs related to convertible note payable | ( | ) | ||||||
| Payment for finance costs | ( | ) | ||||||
| Net cash provided by financing activities | ( | ) | ||||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents, beginning of period | ||||||||
| Cash and cash equivalents, end of period | $ | $ | ||||||
| Cash paid for: | ||||||||
| Interest | $ | $ | ||||||
| Income taxes | $ | $ | ||||||
| Supplemental non-cash financing activities: | ||||||||
| Common stock issued for settlement of debt | $ | $ | ||||||
| Finance costs accrued in accounts payable | $ | $ | ||||||
| Warrants issued for financing fees, net of issuance fees of $ | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 4 |
Note 1 – Organization and Liquidity
Organization and Line of Business
Shuttle
Pharmaceuticals Holdings, Inc. (“we”, “us”, “our”, 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
shares of common stock in exchange for
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 though 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 has 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 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 $
In
January 2023, the Company entered into a securities purchase agreement with an institutional investor through which the Company sold
a convertible note with a principal value of $
The IPO and subsequent capital raise have supported operations leading up to the manufacture of drug product and FDA approval of the IND for the Phase II clinical trial of Ropidoxuridine and radiation therapy in glioblastoma. The FDA recommended and the Company agreed to an expansion of the clinical trial, necessitating additional capital to complete the trial as well as fund ongoing operations. As a result, we are in the process of filing a registration statement on Form S-1 to raise additional capital. We presently intend to commence the capital raise shortly after we complete the Re-audit noted below in Note 2, Restatement of Previously Issued Financial Statements. The Company may also pursue additional bridge financing pending the completion of the registration statement.
The accompanying 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.
Reverse Stock Split
On
August 13, 2024, in order to meet Nasdaq’s minimum bid price requirement of $
| 5 |
Note 2 – Restatement of Previously Issued Financial Statements
As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on May 13, 2024, following the entry of a cease-and-desist order by the SEC against our former auditor, B.F. Borgers CPA PC (“BF Borgers”), we commenced the re-audit (the “Re-audit”) of our financial statements for the year ended December 31, 2022, which had been audited by BF Borgers. Since that time and as a result of the Re-audit, and as initially disclosed on Form 8-K dated July 10, 2024, the Company and the Audit Committee have concluded and informed our current auditor, Forvis Mazars, LLP, that our audited financial statements for the year ended December 31, 2022 (the “2022 Financial Statements”), our audited financial statements for the year ended December 31, 2023 (the “2023 Financial Statements”), and the quarterly periods included in the Company’s Annual Report for the year ended December 31, 2023, and the quarterly report for the period ended March 31, 2024 require restatement and are not reliable.
The accounting errors impacting our 2022 Financial Statements include:
Stock Compensation
| ● | Application of the incorrect grant date fair values in determining the value of certain equity awards granted during the years ended December 31, 2019 and 2020; | |
| ● | Miscalculation of the pattern of recognition of stock-based compensation over the requisite service periods for certain equity awards granted during the years ended December 31, 2019 and 2020; |
Series A Convertible Preferred Stock
| ● | Utilization of incorrect inputs to the fair value estimates for the warrant obligation related to the Series A Convertible Preferred Stock; incorrectly recording the reclassification of the warrant obligation upon issuance as a gain and not as a reclassification to stockholders’ equity; | |
| ● | Recording of accrued dividends on the Series A Convertible Preferred Stock as a liability prior to the dividends being declared; | |
| ● | Failure to recognize the accounting impact for the amendment to the terms of the Series A Convertible Preferred Stock in April 2022, which the Company subsequently concluded should have been recognized as an extinguishment; | |
| ● | Failure to recognize deemed contribution related to the settlement of the Series A Convertible Preferred Stock and accrued dividends; |
Notes Payable
| ● | Misidentification of certain debt and equity issuance costs and incorrect association with certain of the Company’s financings during the years ended December 31, 2022 and 2021; | |
| ● | Application of the incorrect amortization period and pattern of recognition for debt discounts recorded in relation to the Company’s debt financings during the years ended December 31, 2022 and 2021; | |
| ● | Incorrect recognition of bifurcated derivative liabilities, as well as incorrect initial and subsequent fair value measurements, in relation to the December 2021 Notes, 2022 Convertible Notes and August 2022 Notes; | |
| ● | Misclassification of certain warrants issued with debt transactions during the year ended December 31, 2022; | |
| ● | Failure to recognize certain liability-classified warrants issued in exchange for services provided related to the Company’s financing activities during the year ended December 31, 2022; | |
| ● | Incorrect application of extinguishment or conversion models in accounting for certain debt instruments upon their settlement; and |
Initial Public Offering
| ● | Incorrect identification of deferred issuance costs incurred in relation to the initial public offering; Incorrect identification and classification of issuance costs incurred in relation to the initial public offering. |
The impact of the errors described above also impact the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024 and March 31, 2023 within Additional Paid In Capital and Accumulated Deficit, resulting in the presentation and filing of this Quarterly Report on Form 10-Q/A.
The Company’s prior and updated accounting for the errors described above do not have any effect on the Company’s previously reported cash or cash flows.
The following tables summarize the effect of the restatement on each financial statement line item as of the dates indicated:
| Consolidated Balance Sheet as of March 31, 2024 | As Reported | Adjustment | As Restated | |||||||||
| Additional paid in capital | ||||||||||||
| Accumulated deficit | ( | ) | ( | ) | ( | ) | ||||||
| Consolidated Balance Sheet as of December 31, 2023 | As Reported | Adjustment | As Restated | |||||||||
| Additional paid in capital | ||||||||||||
| Accumulated deficit | ( | ) | ( | ) | ( | ) | ||||||
| 6 |
Note 3 – 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 accounting principles generally accepted in the United States of America 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, 2023.
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, 2024 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 condensed consolidated balance sheet was derived from audited financial statements. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the operating results for the full fiscal year or any future period. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on [August [*], 2024].
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.
| 7 |
Use of Estimates
The preparation of 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 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 condensed consolidated financial statements for the recognition of research and development expenses, valuation of warrants and valuation of bifurcated derivative liabilities and other financial instruments.
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, 2024 and December 31, 2023, cash and cash equivalents consisted of the following:
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash | $ | $ | ||||||
| Money market funds | ||||||||
| $ | $ | |||||||
Periodically,
the Company may carry cash balances at financial institutions in excess of the federally insured limit of $
Marketable Securities
Our investments in debt securities are carried at fair value. Investments in debt securities that are not classified as held-to-maturity are carried at fair value and classified as either trading or available-for-sale. Realized and unrealized gains and losses on trading of debt securities are charged to income.
The
marketable securities held by the Company, which are classified as trading marketable securities, consisted of an outstanding
balance of $
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. |
| 8 |
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.
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, 2024 and December 31, 2023:
| March 31, 2024 | Level 1 | Level 2 | Level 3 | Carrying Value | ||||||||||||
| Assets | ||||||||||||||||
| Marketable Securities: | ||||||||||||||||
| United States Treasury Bonds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities | ||||||||||||||||
| Derivative Liability - Warrants | $ | $ | $ | $ | ||||||||||||
| Derivative Liability - Accelerated feature | ||||||||||||||||
| Total Liabilities | $ | $ | $ | $ | ||||||||||||
| December 31, 2023 | Level 1 | Level 2 | Level 3 | Carrying Value | ||||||||||||
| Assets | ||||||||||||||||
| Marketable Securities: | ||||||||||||||||
| United States Treasury Bonds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities | ||||||||||||||||
| Derivative Liability - Warrants | $ | $ | $ | $ | ||||||||||||
| Derivative Liability - Accelerated feature | ||||||||||||||||
| Total Liabilities | $ | $ | $ | $ | ||||||||||||
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. We evaluate all of our 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 our liability classified derivative financial instruments, the Company used a Monte Carlo valuation model to value the derivative instruments at inception and on subsequent valuation dates. For our equity classified derivative financial instruments, we used a Black-Scholes option-pricing model at the grant date to value the derivative instrument. 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 condensed consolidated balance 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.
| 9 |
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 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 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 Black-Scholes pricing model or a Monte Carlo simulation.
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 our chief executive officer, chief operating officer, chief financial officer and directors’ compensation. For the three months ended March 31, 2024 and 2023, a portion of personnel-related expenses and stock-based compensation expense for these individuals totaling $ thousand and $ thousand, 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.
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, we disclose 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, we understand 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. There were no reimbursements received for the three months ended March 31, 2024 and 2023.
Net loss per share of common stock requires presentation of basic earnings per common share on the face of the unaudited condensed 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. In the accompanying 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. 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 outstanding 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.
| 10 |
The dilutive effect of restricted stock units subject to vesting 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.
| March 31, | March 31, | |||||||
| 2024 | 2023 | |||||||
| Convertible notes (Note 6) | ||||||||
| Warrant (Note 7) | ||||||||
| Restricted stock units (Note 7) | ||||||||
Deferred Offering Costs
Pursuant to ASC 340-10-S99-1, costs directly attributable to an offering of equity securities are deferred and would be charged against the gross proceeds of an offering as a reduction of additional paid-in capital. Deferred offering costs may consist of underwriting, legal, accounting, and other expenses incurred through the balance sheet date that are directly related to a proposed public offering. Should the proposed public offering prove to be unsuccessful, any deferred costs, as well as additional expenses to be incurred, will be expensed.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting Topic 280, “Segment Reporting-Improvements to Reportable Segment Disclosures,” which allows disclosure of one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires enhanced disclosures of significant segment expenses and other segment items, as well as incremental qualitative disclosures on both an annual and interim basis. This guidance is effective for annual reporting periods beginning after December 15, 2023, and interim reporting periods after December 15, 2024. Early adoption is permitted and retrospective application is required for all periods presented. The adoption of this new guidance is not expected to have a significant impact on our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes Topic 740, “Income Tax-Improvements to Income Tax Disclosures,” which requires enhanced disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. This guidance is effective for annual reporting periods beginning after December 15, 2024. Early adoption is permitted and should be applied on a prospective basis, however retrospective application is permitted. The Company is currently evaluating the impact of adopting this guidance on its consolidated and condensed financial statements and disclosures included within notes to consolidated and condensed financial statements.
| 11 |
Note 4 – 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.
During the three months ended March 31, 2023, the Company had a lease agreement
which allowed for the use of a laboratory facility for a monthly payment of $
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 $
The following summarizes the right-of use asset and lease information for the Company’s operating leases:
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating lease cost | $ | $ | ||||||
| Variable lease cost | ||||||||
| Sublease income | ( | ) | ( | ) | ||||
| Total lease cost | $ | $ | ||||||
| Other information | ||||||||
| Operating cash flows from operating leases | $ | $ | ||||||
| Weighted-average remaining lease term - operating leases (year) | ||||||||
| Weighted-average discount rate - operating leases | % | % | ||||||
Future non-cancelable minimum lease payments under the operating lease liability as of March 31, 2024, are as follows:
| Years ended December 31, | ||||
| 2024 (excluding the three months ended March 31, 2024) | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| Total future minimum lease payments | ||||
| Less: imputed interest | ( | ) | ||
| Present value of payments | $ | |||
Note 5 – Notes Payable-Related Party
During
the three months ended March 31, 2024 and 2023 the Company incurred $ and $
| 12 |
Note 6 – Convertible Notes and Notes Payable
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 $
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 defaults 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 $
Boustead
Securities, LLC (“Boustead”) served as a placement agent for the Alto Convertible Note and Warrant offering and received
$
| 13 |
The
Company allocated the finance costs related to the Boustead placement agent fee of $
The
Company allocated to the debt component of the note an original discount of $
During
the three months ended March 31, 2024, the Company recorded interest expense of $
During
the three months ended March 31, 2023, the Company recorded interest expense of $
As
of March 31, 2024, the outstanding principal for the convertible note was $
Subsequent to March 31, 2024, the Company and the Investor agreed to certain changes in terms of the Alto Convertible Note as well as the waiver of certain covenant violations. See Subsequent Events for further details.
| 14 |
Note 7 – Stockholders’ Equity
Common Stock
During the three months ended March 31, 2024, the Company issued:
| ● |
shares of common stock to settle $ | |
| ● | shares of common stock issued for vesting of restricted stock units. |
During the three months ended March 31, 2023, the Company issued:
| ● |
shares of Common Stock to settle $ |
Warrants
In
connection with the January 2023 Alto Convertible Note, Boustead was granted warrants to purchase
A summary of activity regarding all warrants issued for the three months ended March 31, 2024 were as follows:
| Number of | Weighted Average | Weighted Average | ||||||||||
| Warrants | Exercise Price | Life (years) | ||||||||||
| Outstanding, December 31, 2023 | $ | |||||||||||
| Granted | — | |||||||||||
| Outstanding, March 31, 2024 | $ | |||||||||||
The intrinsic value of the warrants as of March 31, 2024 is $. All of the outstanding warrants are exercisable as of March 31, 2024.
Equity Incentive Plan
Our 2018 Equity Incentive Plan (the “2018 Plan”) provides for equity incentives to be granted to our 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 Equity Incentive Plan, restricted stock awards, other stock-based awards, or any combination of the foregoing. The 2018 Equity Incentive Plan is administered by the Company’s compensation committee. We have reserved shares of our common stock for issuance under the 2018 Equity Incentive Plan. As of March 31, 2024, shares have been granted under the 2018 Equity Incentive Plan, of which shares have vested.
Restricted Stock Units
We 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 our 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.
| 15 |
During
the three months ended March 31, 2024 and 2023, pursuant to agreements with officers and consultants, and RSUs with a value
of $
As of March 31, 2024, there was $ of unrecognized RSU compensation cost related to non-vested share-based compensation arrangements which is expected to be recognized over a weighted-average period of years.
| Number of RSU | Weighted Average Fair Value Per RSU | |||||||
| Outstanding, December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Outstanding, March 31, 2024 | $ | |||||||
Rights Offering and Financing Commitment
On
February 7, 2024, the Company and its wholly-owned subsidiary, Shuttle Diagnostics, Inc., entered into a securities purchase
agreement (the “Purchase Agreement”) with SRO, LLC, a Nevada limited liability company, pursuant to which SRO LLC agreed
to commit to purchasing from the Company $
The
Company filed an initial registration statement on Form S-1 (the “Form S-1”) with the SEC in April 2024 related to the
registration of subscription rights to purchase the Units to be sold in the Rights Offering. The Form S-1 has not been declared
effective as of the date these condensed consolidated financial statements were issued. Upon the Form S-1 being declared effective,
the Purchase Agreement allows SRO LLC up to 60 days to raise the initial $
In
conjunction with its entry into the Purchase Agreement, on February 7, 2024, the Company entered into a placement agent and advisory
services agreement (the “Placement Agent Agreement”) with BSL, pursuant to which BSL and BSL’s affiliates will provide
the Company with regular and customary financial consulting advice and will act as placement agent, on a best efforts basis, for the
Rights Offering. In exchange for its services, BSL will receive a commitment fee equal to $
As
of March 31, 2024, the Company has incurred $
| 16 |
Note 8 – Derivative Liabilities
Fair Value Assumptions Used in Accounting for Derivative Liabilities
ASC 815 requires us 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
January 2023, in connection with the Alto Convertible Note, the Company issued warrants to purchase
The Company determined our derivative liability from the noteholder’s Acceleration Option for the Alto Convertible Note is not clearly and closely related to the host and should be thus accounted for as a bifurcated derivative liability.
The
Company classified these derivative liabilities as a Level 3 fair value measurement and used the Monte Carlo pricing model to calculate
the fair value as of January 11, 2023 ($
The key inputs for the Monte Carlo simulation as of March 31, 2024, were as follows:
| Net cash settlement and down round key valuation inputs - warrants* | ||||
| Annualized volatility | % | |||
| Risk-free interest rate | % | |||
| Quoted VWAP* | $ | |||
| Exercise price | $ | |||
| Probability assessment | % | |||
| Illiquidity discount | ( | )% | ||
| Time period (years) | ||||
| * |
| Acceleration option key valuation inputs* | ||||
| Annualized volatility | % | |||
| Risk-free interest rate | % | |||
| Quoted VWAP* | $ | |||
| Illiquidity discount | ( | )% | ||
| Time period (years) | ||||
| * |
The following table summarizes the changes in the derivative liabilities:
| Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | ||||||||
| Warrants | Accelerated Feature | |||||||
| Balance - December 31, 2023 | $ | $ | ||||||
| Gain on change in fair value | ( | ) | ( | ) | ||||
| Balance - March 31, 2024 | $ | $ | ||||||
| 17 |
Note 9 – Related Party Transactions
On
September 14, 2022, we entered into a manufacturing agreement with TCG GreenChem, Inc. (“TCG GreenChem”), the U.S.
subsidiary of TCG Lifesciences Pvt Ltd., a global contract research and manufacturing services company located in India. Dr. Chis
Senanayake, one of our independent directors, is CEO and CSO of TCG GreenChem and CSO of TCG Lifesciences Pvt Ltd. TCG GreenChem was
contracted for process research, development and cGMP compliant manufacture of IPdR. During the three months ended March 31, 2024
and 2023, the Company expensed $
Note 10 – Subsequent Events
See above Note 2, Restatement of Previously Issued Financial Statements and Note 1, Summary of Significant Accounting Policies, Reverse Stock Split.
Alto Opportunity Master Fund, SPC
On
July 12, 2024, the Company informed the Investor in the Alto Convertible Note that the Company’s expected restatement of its
consolidated financial statements for the years ended December 31, 2022 and 2023 constituted an event of default under the terms of
the Alto Convertible Note. On August 6, 2024, the Company paid $
Alliance Global Partners
On
July 30, 2024, the Company engaged A.G. P./Alliance Global Partners (“AGP”) to serve as exclusive underwriter, placement
agent or advisor in any public or private offering or financing (as defined, the “Offering”) of up to $
Phase II study of Ropidoxuridine
On August 8, 2024, the Company entered into a work order (the “Work Order”) with Theradex Systems, Inc., a New Jersey contract research organization (“CRO”) for purposes of supporting the Company’s Phase II Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with Unmethylated MGMT Promotor.” As such, Shuttle Pharma is now in the process of signing up six clinical sites where the clinical studies will be performed – two of which have completed initial site initiation visits and one of which is ready to enroll patients – and where the CRO will oversee such studies.
Under
the terms of the Work Order, the CRO will oversee the studies for a period of 53 months (the “Term”), including overseeing
and monitoring the regulatory aspects of the Phase II clinical trial, and managing the documentation surrounding the clinical trial in
exchange for a fee of approximately $
| 18 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following Management’s Discussion and Analysis should be read in conjunction with our financial statements and the related notes thereto included elsewhere in this Quarterly Report. This discussion has been impacted by the restatement described in the Explanatory Note and in Note 2 of the condensed consolidated financial statements of this Quarterly Report. Certain of the financial and other information provided in this Management’s Discussion and Analysis has been updated to reflect the restatement adjustments.
The Management’s Discussion and Analysis 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 Quarterly 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 this Quarterly Report.
We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Quarterly Report, except as required by U.S. federal securities laws.
Overview
Founded by Georgetown University Medical School faculty members, Shuttle Pharmaceuticals Holdings, Inc. (the “Company”) 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 available with the current standard of care.
| 19 |
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 new SBIR contract work on predictive biomarkers of radiation response, as well as prostate cell lines for health disparities research. We have received Small Business Innovation Research (“SBIR”) contract funding from the National Institutes of Health (“NIH”) for the aforementioned projects. The clinical development of Ropidoxuridine has shown drug bioavailability and a maximum tolerated dose has been established for use in Phase II clinical trials. TCG GreenChem, Inc. (“TCG GreenChem”), with whom we have contracted for process research, development and cGMP compliant manufacture of IPdR, has successfully completed the manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy. Shuttle also worked with University of Iowa Pharmaceuticals to develop the formulation and produce the capsules, which have been shipped to contract research organization (CRO) Theradex Oncology for distribution to clinical trial sites. Both activities have now been completed. In addition, Shuttle received approval from the FDA to begin the clinical trial. The FDA made recommendations to expand the clinical trial and we agreed with the recommendation. Meetings with clinical sites to review the protocol documents have occurred and FDA required Institutional Review Board approval has been received from the central internal review board, or IRB. With FDA recommended changes incorporated into the revised protocol, the Company believes it remains on track to commence its Phase II clinical study in the second quarter of 2024. The radiation biomarker project and the health disparities project have been completed and the company is following up with plans for clinical validation and potential commercialization. Changes in operational, administrative, legal and professional expenses related to our operations are set forth in more detail in the discussion below.
Restatement of Previously Issued Consolidated Financial Statements
As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on May 13, 2024, following the entry of a cease-and-desist order by the SEC against our former auditor, B.F. Borgers CPA PC (“BF Borgers”), we commenced the re-audit (the “Re-audit”) of our financial statements for the year ended December 31, 2022, which had been audited by BF Borgers. Since that time and as a result of the Re-audit, as of July 10, 2024, the Company and the Audit Committee have concluded and informed our current auditor, Forvis, that our audited financial statements for the year ended December 31, 2022 (the “2022 Financial Statements”), our audited financial statements for the year ended December 31, 2023 (the “2023 Financial Statements”), and the quarterly periods included in the Company’s Annual Report for the year ended December 31, 2023, and the quarterly report for the period ended March 31, 2024 require restatement and are not reliable.
The accounting errors impacting our 2022 Financial Statements include (i) correcting historical and fiscal 2022 stock compensation transactions; (ii) correcting the initial and subsequent accounting for certain convertible notes, promissory notes and warrants to purchase shares of common stock in fiscal 2022; (iii) correcting the historical and subsequent accounting for the Series A Convertible Preferred Stock in fiscal 2022; (iv) correcting the initial and subsequent accounting for warrants issued with the Series A Convertible Preferred Stock, and (v) correcting the recognition of issuance costs related to the initial public offering in fiscal 2022.
The impact of the accounting errors from the 2022 Financial Statements also impacts the Company’s 2023 Financial Statements specific to additional paid in capital and accumulated deficit.
The discussion of financial results presented here is reflective of the restatement adjustments. Refer to Note 2 of the condensed consolidated financial statements included elsewhere in this Quarterly Report for more information on the restatement.
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. Following the reverse stock split on August 13, 2024, the Company had a total of 2,111,235 shares issued and outstanding (or 2,102,511 on a post-split basis as of March 31, 2024). All share, option, warrant and per share amounts (except our authorized outstanding) have been retroactively restated in these financial statements and related disclosures.
| 20 |
Results of Operations
Comparison of the three months ended March 31, 2024 and 2023
The following table summarizes the results of our operations:
| Three Months Ended | ||||||||||||||||
| March 31, | ||||||||||||||||
| 2024 | 2023 | Change | % | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | — | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 586,104 | 921,801 | (335,697 | ) | (36 | )% | ||||||||||
| General and administrative | 324,609 | 255,355 | 69,254 | 27 | % | |||||||||||
| Legal and professional | 474,134 | 367,624 | 106,510 | 29 | % | |||||||||||
| Total operating expenses and loss of operations | 1,384,847 | 1,544,780 | (159,933 | ) | (10 | )% | ||||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense - related parties | — | (4,237 | ) | 4,237 | (100 | )% | ||||||||||
| Interest expense | (497,515 | ) | (599,331 | ) | 101,816 | (17 | )% | |||||||||
| Interest income | 21,453 | 16,688 | 4,765 | 29 | % | |||||||||||
| Finance fee | — | (104,245 | ) | 104,245 | (100 | )% | ||||||||||
| Change in fair value of derivative liabilities | 197,862 | 1,241,000 | (1,043,138 | ) | (84 | )% | ||||||||||
| Gain on sale of marketable securities | 4,037 | — | 4,037 | 100 | % | |||||||||||
| Change in fair value of marketable securities | (706 | ) | 38,062 | (38,768 | ) | (102 | )% | |||||||||
| Loss on settlement of convertible debt | (71,315 | ) | (18,254 | ) | (53,061 | ) | 291 | % | ||||||||
| Total other expense | (346,184 | ) | 569,683 | (915,867 | ) | (161 | )% | |||||||||
| Net loss | $ | (1,731,031 | ) | $ | (975,097 | ) | (755,934 | ) | 78 | % | ||||||
Research and Development, net of contract expense reimbursements. Total research and development (“R&D”) expense was $0.6 million for the three months ended March 31, 2024, as compared to $0.9 million for the three months ended March 31, 2023. The decrease of $0.3 million, or 36%, is primarily related to the Company having completed production of the drug product and waiting for the initiation of trials.
R&D compensation related expenses were $0.3 million in the three months ended March 31, 2024 as compared to $0.6 million in the three months ended March 31, 2023. Compensation related expenses were 56% for the three months ended March 31, 2024, representing a decrease from 61% of total R&D in the three months ended March 31, 2023. Subcontract work made up 34% of total R&D expenses in the three months ended March 31, 2024 and 37% of total R&D expenses during the three months ended March 31, 2023.
General and Administrative Expenses. General and Administrative expenses in the three months ended March 31, 2024 increased by $0.1 million, or 27%, from $0.3 million in the three months ended March 31, 2023. The increase in general and administrative expenses was primarily due to a restricted stock-based grant to an officer of the Company valued at $41,840.
Legal and Professional Expenses. During the three months ended March 31, 2024, legal and professional expenses increased by $0.1 million or 29%. The increase in legal and professional fees was primarily due to increases in our expenses related to our public filing requirements, contracts and financing related work.
Other Income (expense) Other expense was $0.3 million for the three months ended March 31, 2024, which consisted of $0.5 million in interest expense on convertible loans, interest income of $21 thousand, loss on settlement of convertible debt of $71 thousand, change in marketable securities of $4 thousand, and a gain on change in fair value of derivative liabilities of $0.2 million. Other income was $0.6 million for the three months ended March 31, 2023, which consisted of $0.6 million in interest expense on convertible loans, $4 thousand in interest expense on related party loans, interest income of $17 thousand, finance fee on convertible loans of $0.1 million, loss on settlement of convertible debt of $18 thousand, unrealized gain on marketable securities of $38 thousand, and a gain on change in fair value of derivative liability of $1.2 million. The $1.0 million gain in fair value of derivative liability resulted from the fair value measurement using the Monte Carlo pricing model and the impact of the decrease in the market price of warrant shares.
| 21 |
Liquidity and Capital Resources
Our 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 had a net loss of approximately $1.7 million and no revenues for the three months ended March 31, 2024 and has working capital of approximately $2.9 million as of March 31, 2024. In addition, the convertible note payable outstanding at March 31, 2024 includes covenants and certain cash payment requirements. These conditions, and the Company’s ability to comply with such conditions, raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued.
In September 2022, the Company completed its IPO, generating net proceeds of approximately $10.0 million. Additionally, in January 2023, the Company entered into a securities purchase agreement with an institutional investor through which the Company sold a convertible note with a principal value of $4.3 million, along with a four-year warrant to purchase 127,260 shares of common stock, exercisable at $18.80 per share, providing the Company with approximately $3.6 million in net proceeds. To date, the warrant has not yet been exercised. However, the Company’s existing cash resources, marketable securities and the cash received from the equity offering and convertible note are not expected to provide sufficient funds to carry out the Company’s operations and clinical trials through the next twelve months.
The IPO and subsequent capital raise have supported operations leading up to the manufacture of drug product and FDA approval of the IND for the Phase II clinical trial of Ropidoxuridine and radiation therapy in glioblastoma. The FDA recommended and the Company agreed to an expansion of the clinical trial, necessitating additional capital to complete the trial as well as fund ongoing operations. As a result, management initiated a $4.5 million rights offering and submitted an application for a Small Business Innovation Research (“SBIR”) grant for non-dilutive funding for pre-clinical project through the National Institutes of Health (“NIH”). The Phase II clinical trial was also approved by the Institutional Review Board “IRB” in June, 2024. In August 2024, the Company took action to pursue a separate capital raise of up to $10 million and entered into a work order with a contract research organization (“CRO”) for purposes of supporting the Company’s Phase II Study of Ropidoxuridine. Under the terms of the work order, the CRO will oversee the studies for a period of 53 months in exchange for a fee of approximately $2.3 million, payable in stages and based upon services performed during the study. The ability of the Company to continue as a going concern is dependent upon its ability 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.
The accompanying 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.
Balance Sheet Data:
| March 31, | December 31, | |||||||||||||||
| 2024 | 2023 | Change | % | |||||||||||||
| Current assets | $ | 4,411,019 | $ | 5,593,005 | $ | (1,181,986 | ) | (21 | )% | |||||||
| Current liabilities | 1,489,217 | 1,042,237 | 446,980 | 43 | % | |||||||||||
| Working capital | $ | 2,921,802 | $ | 4,550,768 | $ | (1,628,966 | ) | (36 | )% | |||||||
As of March 31, 2024, total current assets were $4.4 million and total current liabilities were $1.5 million, resulting in working capital of $2.9 million. As of December 31, 2023, total current assets were $5.6 million and total current liabilities were $1.0 million, resulting in a working capital of $4.6 million. As of March 31, 2024, the current assets primarily resulted from $1.4 million cash and $2.8 million marketable securities, with the decrease from December 31, 2023 being primarily due to ongoing cash burn from our R&D programs, filing expenses and general operations. The increase in current liabilities is primarily due to the current portion of the $4,300,000 convertible note and accrued interest that increased $0.4 million and an increase in accounts payable of $65 thousand.
| 22 |
Cash Flows from Operating Activities
| Three Month Ended | ||||||||||||||||
| March 31, | ||||||||||||||||
| 2024 | 2023 | Change | % | |||||||||||||
| Cash used in operating activities | $ | (1,239,083 | ) | $ | (1,337,982 | ) | $ | 98,899 | (7 | )% | ||||||
| Cash used in investing activities | $ | 101,295 | $ | (2,953,709 | ) | $ | 3,055,004 | (103 | )% | |||||||
| Cash provided by financing activities | $ | (40,000 | ) | $ | 3,043,756 | $ | (3,083,756 | ) | (101 | )% | ||||||
| Cash on hand | $ | 1,398,628 | $ | 7,169,268 | $ | (5,770,640 | ) | (80 | )% | |||||||
To date, we have not generated positive cash flows from operating activities. For the three months ended March 31, 2024, net cash flows used in operating activities was $1.2 million, consisting of a 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 $71 thousand, accrued interest settled with common stock of $19 thousand, stock-based compensation of $111 thousand and increased by a net change in working capital of $50 thousand. For the three months ended March 31, 2023, net cash flows used in operating activities was $1.3 million, consisting of a net loss of $1.0 million, increased by a gain on change in derivative liability of $1.2 million, offset by amortization of debt discount of $0.6 million, and further reduced by a net change in working capital of $0.3 million.
Cash Flows from Investing Activities
For the three months ended March 31, 2024, we invested in trading marketable securities for $19 thousand and received $120 thousand in proceeds from disposition of marketable securities. For the three months ended March 31, 2023, we invested in trading marketable securities for $3.0 million.
Cash Flows from Financing Activities
For the three months ended March 31, 2024, we paid $40,000 related to financing activities. For the three months ended March 31, 2023, we received a net of $3,590,000 from the sale and issuance of convertible notes payable and warrants and repaid $546,244 in related party notes payable.
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.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of these 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 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 our significant accounting policies are described in more detail in the notes to our 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.
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Our most critical accounting policies and estimates relate to the following:
| ● | Initial Measurement of Equity-Based Warrants | |
| ● | Research and Development Expenses | |
| ● | Fair Value of Derivative Financial Instruments |
Initial Measurement of Equity-Based Warrants
We evaluate all of our 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 equity, the derivative instrument is initially recorded at its fair value and recorded to additional paid in capital. The classification of derivative instruments, including whether such instruments should be recorded as equity, is evaluated at the end of each reporting period.
For our derivative financial instruments classified as equity, the Company used a Black Scholes valuation model, to calculate the fair value on issuance date, without revaluation.
The use of Black Scholes valuation model requires the input of highly subjective assumptions, including the expected price volatility, that is based on an analysis of the historical volatility of the common stock of a group of comparable entities. Any change to these inputs could produce significantly higher or lower fair value measurements.
Research and Development
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 Financial Instruments
We evaluate all of our 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 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, the Company utilizes Monte Carlo or other appropriate valuation models to value the derivative instruments at inception and on subsequent valuation dates. The model requires the use of simulations that are weighted based on significant unobservable inputs including the average volatility of a population set and 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.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as defined in 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, 2024, 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, 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, 2024. Based on the foregoing, our management concluded that our internal controls over the following financial reporting areas to be material weaknesses:
| ● | Our written accounting policies and documentation of management’s contemplation of the accounting treatment and implications over significant unusual transactions, including complex accounting associated with debt and equity transactions, was limited and resulted in ineffective monitoring of financial reporting. These were contributing factors which lead to untimely filings | |
| ● | Due to our size and stage of development, segregation of all conflicting duties may not always be possible and may not be economically feasible. During the year, we lacked sufficient review procedures and segregation of duties such that a proper review had not been performed by someone other than a preparer, including manual journal entries, and that process documentation is lacking for review and monitoring controls over financial statements close process and financial reporting. | |
| ● | As a result of the Company’s evolution since the date of our initial formation, when we were focused on NIH SBIR research contracts with related costing allocation allowances until when we completed our IPO and continued our development process, management has lacked a formal process to identify and properly classify operating expenses such as Research and Development (“R&D”). | |
| ● | We identified findings related to overall information technology general controls (“ITGCs”) including issues with access and segregation of duties for systems supporting the Company’s internal control processes and controls. | |
| ● | Our accounting policies and oversight regarding certain technical aspects of financial reporting for stock-based compensation transactions, particularly relating to grant date valuations and expense attribution, was also limited and resulted in the incorrect recording of related compensation expense and related disclosures. |
There has been no change in the Company’s internal control over financial reporting during the three months ended March 31, 2024 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.
Management’s Remediation Measures
The aforementioned material weaknesses were identified in 2023 and the ineffective monitoring of financial reporting weakness resulted in the Company needing to restate its 2023 and 2022 financial statements. 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 (“CFO”) during the second quarter of 2024 to bolster the Company’s internal technical accounting and financial reporting experience and provide bandwidth for the prior CFO 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.
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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
None.
Item 6. Exhibits
The following exhibits are filed or furnished with this report:
* Filed herewith.
**Furnished herewith.
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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. | ||
| September 3, 2024 | By: | /s/ Anatoly Dritschilo |
| Anatoly Dritschilo, M.D. | ||
| Chief Executive Officer | ||
| September 3, 2024 | By: | /s/ Timothy J. Lorber |
Timothy J. Lorber Chief Financial Officer | ||
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