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utr:D
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q/A
(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 March 31, 2024
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 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 |
|
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 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 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 2,226,951.
EXPLANATORY
NOTE
This
Amendment No. 1 to Form 10-Q/A (the “Amendment No.1”) amends the Quarterly Report on Form 10-Q of Shuttle
Pharmaceuticals Holdings, Inc. (the “Company”) for the fiscal quarter ended March 31, 2024, as filed with the Securities
and Exchange Commission, or the SEC, on May 13, 2024 (the “Original Filing”). As previously reported, following the
entry of a cease-and-desist order entered on May 3, 2024 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 of our board of directors, in consultation with our current auditor, Forvis Mazars, LLP, concluded 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 and the quarterly periods included in the Company’s Form 10-K, and
the Original Filing require restatement and are not reliable.
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
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 | |
$ | 1,398,628 | | |
$ | 2,576,416 | |
Prepaid expenses | |
| 129,642 | | |
| 114,473 | |
Marketable securities | |
| 2,789,251 | | |
| 2,887,215 | |
Accrued interest income | |
| 11,964 | | |
| 14,901 | |
Other current assets | |
| 81,534 | | |
| — | |
Total current assets | |
| 4,411,019 | | |
| 5,593,005 | |
| |
| | | |
| | |
Property and equipment, net | |
| 22,915 | | |
| 24,827 | |
Operating lease right-of-use asset | |
| 319,987 | | |
| 333,904 | |
Total Assets | |
$ | 4,753,921 | | |
$ | 5,951,736 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 347,556 | | |
$ | 282,860 | |
Accounts payable and accrued expenses related party | |
| — | | |
| 446 | |
Accounts payable and accrued expenses | |
| - | | |
| 446 | |
Accrued interest payable | |
| 143,676 | | |
| 110,453 | |
Convertible notes payable, net | |
| 941,398 | | |
| 595,999 | |
Derivative liability | |
| 2,035 | | |
| — | |
Operating lease liability | |
| 54,552 | | |
| 52,479 | |
Total Current Liabilities | |
| 1,489,217 | | |
| 1,042,237 | |
| |
| | | |
| | |
Convertible notes payable non-current, net | |
| — | | |
| 135,089 | |
Derivative liabilities non-current | |
| 214,615 | | |
| 414,512 | |
Operating lease liability non-current | |
| 288,602 | | |
| 304,127 | |
Total Liabilities | |
| 1,992,434 | | |
| 1,895,965 | |
| |
| | | |
| | |
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; 2,102,511 and 2,008,689 shares issued and outstanding, respectively | |
| 21 | | |
| 20 | |
Additional paid in capital, as restated | |
| 29,925,801 | | |
| 29,489,055 | |
Accumulated deficit, as restated | |
| (27,164,335 | ) | |
| (25,433,304 | ) |
Total Stockholders’ Equity | |
| 2,761,487 | | |
| 4,055,771 | |
Total Liabilities and Stockholders’ Equity | |
$ | 4,753,921 | | |
$ | 5,951,736 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Shuttle
Pharmaceuticals Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
2024 |
|
|
2023 |
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
586,104 |
|
|
|
921,801 |
|
General and administrative |
|
|
324,609 |
|
|
|
255,355 |
|
Legal and professional |
|
|
474,134 |
|
|
|
367,624 |
|
Total operating expenses |
|
|
1,384,847 |
|
|
|
1,544,780 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,384,847 |
) |
|
|
(1,544,780 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Interest expense - related parties |
|
|
— |
|
|
|
(4,237 |
) |
Interest expense |
|
|
(497,515 |
) |
|
|
(599,331 |
) |
Interest income |
|
|
21,453 |
|
|
|
16,688 |
|
Finance fee |
|
|
— |
|
|
|
(104,245 |
) |
Change in fair value of derivative liabilities |
|
|
197,862 |
|
|
|
1,241,000 |
|
Gain on sale of marketable securities |
|
|
4,037 |
|
|
|
— |
|
Change in fair value of marketable securities |
|
|
(706 |
) |
|
|
38,062 |
|
Loss on settlement of convertible debt |
|
|
(71,315 |
) |
|
|
(18,254 |
) |
Total other income (expense) |
|
|
(346,184 |
) |
|
|
569,683 |
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(1,731,031 |
) |
|
$ |
(975,097 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
|
2,075,745 |
|
|
|
1,704,517 |
|
Net loss per shares - basic and diluted |
|
$ |
(0.83 |
) |
|
$ |
(0.57 |
) |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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) | |
| 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 (as restated) | |
| 2,102,511 | | |
$ | 21 | | |
$ | 29,925,801 | | |
$ | (27,164,335 | ) | |
$ | 2,761,487 | |
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) | |
| 1,700,414 | | |
$ | 17 | | |
$ | 26,518,433 | | |
$ | (18,840,581 | ) | |
$ | 7,677,869 | |
Balance | |
| 1,700,414 | | |
$ | 17 | | |
$ | 26,518,433 | | |
$ | (18,840,581 | ) | |
$ | 7,677,869 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Warrants issued for financing costs | |
| — | | |
| — | | |
| 90,816 | | |
| — | | |
| 90,816 | |
Common stock issued for conversion of accrued interest and principal | |
| 6,375 | | |
| — | | |
| 104,547 | | |
| — | | |
| 104,547 | |
Stock-based compensation | |
| — | | |
| — | | |
| 8,333 | | |
| — | | |
| 8,333 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (975,097 | ) | |
| (975,097 | ) |
Balance - March 31, 2023 (as restated) | |
| 1,706,789 | | |
$ | 17 | | |
$ | 26,722,129 | | |
$ | (19,815,678 | ) | |
$ | 6,906,468 | |
Balance | |
| 1,706,789 | | |
| 17 | | |
| 26,722,129 | | |
| (19,815,678 | ) | |
| 6,906,468 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Shuttle
Pharmaceuticals Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
| |
2024 | | |
2023 | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (1,731,031 | ) | |
$ | (975,097 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 1,912 | | |
| 1,488 | |
Change in fair value of derivative liability | |
| (197,862 | ) | |
| (1,241,000 | ) |
Amortization of debt discount and finance fees | |
| 445,509 | | |
| 567,297 | |
Gain on marketable securities | |
| (4,037 | ) | |
| — | |
Change in fair value of marketable securities | |
| 706 | | |
| (38,062 | ) |
Accrued interest settled with common stock | |
| 18,783 | | |
| 20,142 | |
Loss on settlement of convertible debt | |
| 71,315 | | |
| 18,254 | |
Stock-based compensation | |
| 111,449 | | |
| 8,333 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accrued interest income | |
| 2,937 | | |
| (7,023 | ) |
Prepaid expenses | |
| (15,169 | ) | |
| (42,687 | ) |
Accounts payable and accrued expenses | |
| 23,162 | | |
| 330,729 | |
Accounts payable and accrued expenses - related parties | |
| (446 | ) | |
| (12,500 | ) |
Accrued interest payable | |
| 33,223 | | |
| 116,051 | |
Accrued interest payable - related parties | |
| — | | |
| (74,807 | ) |
Other assets | |
| — | | |
| (7,206 | ) |
Change in operating lease asset and liabilities | |
| 466 | | |
| (1,894 | ) |
Net cash used in operating activities | |
| (1,239,083 | ) | |
| (1,337,982 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Proceeds from disposition of marketable securities | |
| 120,000 | | |
| — | |
Net cash used in investing activities | |
| 101,295 | | |
| (2,953,709 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Repayment of note payable-related party | |
| — | | |
| (546,244 | ) |
Proceeds from convertible notes payable and warrants | |
| — | | |
| 3,935,000 | |
Payment for finance costs related to convertible note payable | |
| — | | |
| (345,000 | ) |
Payment for finance costs | |
| (40,000 | ) | |
| — | |
Net cash provided by financing activities | |
| (40,000 | ) | |
| 3,043,756 | |
| |
| | | |
| | |
Net change in cash and cash equivalents | |
| (1,177,788 | ) | |
| (1,247,935 | ) |
Cash and cash equivalents, beginning of period | |
| 2,576,416 | | |
| 8,417,203 | |
Cash and cash equivalents, end of period | |
$ | 1,398,628 | | |
$ | 7,169,268 | |
| |
| | | |
| | |
Cash paid for: | |
| | | |
| | |
Interest | |
$ | — | | |
$ | 79,044 | |
Income taxes | |
$ | — | | |
$ | — | |
| |
| | | |
| | |
Supplemental non-cash financing activities: | |
| | | |
| | |
Common stock issued for settlement of debt | |
$ | 325,298 | | |
$ | 104,547 | |
Finance costs accrued in accounts payable | |
$ | 41,534 | | |
$ | — | |
Warrants issued for financing fees, net of issuance fees of $0 and $8,727, respectively | |
$ | — | | |
$ | 90,816 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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 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. All share numbers referenced herein reflect a 1-for-8 reverse split of our common stock on a post-split basis, which
was effective as of August 13, 2024 (see Note 2).
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 $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. On July 12, 2024, the Company informed the investor of its convertible
note that the Company’s expected restatement of its financial statements for the years ended December 31, 2022 and 2023 constituted
an event of default under the terms of the convertible note. On August 6, 2024, the Company paid $0.6 million to the investor of the convertible
note and received a waiver from the investor related to the default. The funds paid are restricted and will be held as collateral to the
balance owed under the convertible note (see Note 9). 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
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,
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 $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). The Reverse Stock Split also resulted in an adjustment to the consolidated balance
sheet for the period ended March 31, 2024 and the year ended December 31, 2023 within additional paid in capital of $147 and $141,
respectively, and an offsetting adjustment to the carrying value of common stock. All share, option, warrant and per share amounts
(except our authorized outstanding) have been retroactively restated in these financial statements and related
disclosures. The effect of the Reverse Stock Split has been included in Note 2 in the
“As Reported” amounts for additional paid in capital.
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:
Schedule
of Restatement On Each Financial Statement
Consolidated Balance Sheet as of March 31, 2024 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,980,109 | | |
| 9,945,692 | | |
| 29,925,801 | |
Accumulated deficit | |
| (17,218,643 | ) | |
| (9,945,692 | ) | |
| (27,164,335 | ) |
Consolidated Balance Sheet as of December 31, 2023 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,543,363 | | |
| 9,945,692 | | |
| 29,489,055 | |
Accumulated deficit | |
| (15,487,612 | ) | |
| (9,945,692 | ) | |
| (25,433,304 | ) |
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.
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:
Schedule of Cash and Cash Equivalents
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash | |
$ | 364,069 | | |
$ | 1,550,098 | |
Money market funds | |
| 1,034,559 | | |
| 1,026,318 | |
Total cash and cash equivalents | |
$ | 1,398,628 | | |
$ | 2,576,416 | |
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, 2024 was approximately $1.1 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.
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 $2,789,251
and $2,887,215
as of March 31, 2024 and December 31, 2023, respectively. During the three months ended March 31, 2024 and 2023, the Company
recognized interest income of $13,651
and $16,688,
realized gains of $4,037
and $0,
and unrealized loss of $706
and gain of $38,062,
respectively.
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.
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:
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Total Assets | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 214,615 | | |
$ | — | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 2,035 | | |
| — | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 216,650 | | |
$ | — | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Total Assets | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 410,660 | | |
$ | 410,660 | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 3,852 | | |
| 3,852 | |
Derivative Liability | |
| - | | |
| - | | |
| 3,852 | | |
| 3,852 | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 414,512 | | |
$ | 414,512 | |
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.
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 $165 thousand and
$385 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 Common Stock
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.
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.
For
the three months ended March 31, 2024 and 2023, 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, | |
| |
2024 | | |
2023 | |
Convertible notes (Note 6) | |
| 107,429 | | |
| 236,641 | |
Warrant (Note 7) | |
| 184,000 | | |
| 184,000 | |
Restricted stock units (Note 7) | |
| 34,106 | | |
| 2,966 | |
| |
| 325,535 | | |
| 423,607 | |
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.
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 $6,480. The laboratory lease commenced on October 1,
2018 and expired on October 31, 2023.
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 per month 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, and the expiry date of the LOC is March 1, 2025.
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
| |
2024 | | |
2023 | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Operating lease cost | |
$ | 22,947 | | |
$ | 17,544 | |
Variable lease cost | |
| 10,440 | | |
| — | |
Sublease income | |
| (2,163 | ) | |
| (2,121 | ) |
Total lease cost | |
$ | 31,224 | | |
$ | 15,423 | |
| |
| | | |
| | |
Other information | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 22,482 | | |
$ | 19,440 | |
| |
| | | |
| | |
Weighted-average remaining lease term - operating leases (year) | |
| 4.42 | | |
| 0.56 | |
Weighted-average discount rate - operating leases | |
| 10.48 | % | |
| 10 | % |
Future
non-cancelable minimum lease payments under the operating lease liability as of March 31, 2024, are as follows:
Schedule
of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability
Years ended December 31, | |
| |
2024 (excluding the three months ended March 31, 2024) | |
$ | 69,020 | |
2025 | |
| 94,246 | |
2026 | |
| 97,074 | |
2027 | |
| 99,986 | |
2028 | |
| 68,235 | |
Total future minimum lease payments | |
| 428,561 | |
Less: imputed interest | |
| (85,407 | ) |
Present value of payments | |
$ | 343,154 | |
Note
5 – Notes Payable-Related Party
During
the three months ended March 31, 2024 and 2023 the Company incurred $0 and $4,237 in interest expense. During the three months ended
March 31, 2024 and 2023 principal payments of $and
$
and accrued interest of $
and $
were paid, respectively, on notes to related parties. The principal and accrued interest
for these notes were fully paid by December 31, 2023.
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 $4,300,000
convertible note (the “Alto Convertible Note”) and warrant (the “Warrant”) to purchase 127,260
shares of common stock, exercisable at $18.80
per share, in exchange for gross proceeds of $3,935,000 (the “Investment Amount”) (See Note 8). The Company determined that the Warrant contains a net cash settlement
feature at inception and categorized the Warrant as a liability in the accompanying condensed consolidated financial statements. The
Alto Convertible Note matures on March 11, 2025, but may be extended at the option of the noteholder. The Alto Convertible Note
amortizes on a monthly basis and the Company can make such monthly amortization payments in cash or, subject to certain equity
conditions, in registered shares of common stock or a combination thereof. Installments may be deferred by the noteholder, resulting
in a variable interest rate. However, the effective interest rate is approximately 244%
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 is convertible into shares of common stock at a price per share equal to the lower of (i) $18.80, (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 may convert at any time at a fixed price of $18.80 per share. The noteholder has an acceleration
of installment amount conversion option (the “Acceleration Option”), whereby the noteholder, with certain share
percentage limitations, can 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 has determined the Acceleration Option 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 $1,442,000
at inception, using a Monte Carlo simulation model (Note 8). The Convertible Note is repayable over 26 months and bears interest at the rate of 5%
per annum. Additionally, the note contains certain redemption options and “Make Whole” provisions.
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 $10.0
million in convertible notes and warrants on substantially the same terms as the Alto Convertible Note and Warrant, excluding the Springing
DACA requirement, with such option to be effective through December 31, 2025. The agreement offers the investor an opportunity to participate
in future capital raises at substantially similar terms as the January 11, 2023 agreement. The Company expects 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 is 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 is being amortized to interest expense over the term of the Alto
Convertible Note.
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.
During
the three months ended March 31, 2023, the Company recorded interest expense of $599,331,
which included amortization of debt discount of $463,052
as interest expense and settlement of $20,142
of accrued interest and $66,150
of principal by issuing 6,375 shares of Common Stock.
As
of March 31, 2024, the outstanding principal for the convertible note was $2,019,656 and the debt discount remaining was $1,078,258,
with a net convertible note carrying value of $941,398
as of March 31, 2024.
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.
Note
7 – Stockholders’ Equity
Common
Stock
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. |
|
● |
15,625
shares of common stock issued for vesting of restricted stock units. |
During
the three months ended March 31, 2023, the Company issued:
|
● |
6,375
shares of Common Stock to settle $66,150 of principal and $20,142 of interest on a convertible note and incurred $18,254 of loss
on settlement. |
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 6). In addition, Alto was granted warrants to purchase 127,260 shares of common stock, at an
exercise price of $18.80 per share (Note 6, 8).
A
summary of activity regarding all warrants issued for the three months ended March 31, 2024 were as follows:
Schedule of Warrants Activity
| |
Number of | | |
Weighted Average | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | | |
Life (years) | |
Outstanding, December 31, 2023 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.77 | |
Granted | |
| — | | |
| — | | |
| — | |
Outstanding, March 31, 2024 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.53 | |
The
intrinsic value of the warrants as of March 31, 2024 is $0. 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 3,000,000 shares of our common stock for issuance under the 2018 Equity Incentive Plan. As of
March 31, 2024, 109,773 shares have been granted under the 2018 Equity Incentive Plan, of which 75,673 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.
During
the three months ended March 31, 2024 and 2023, pursuant to agreements with officers and consultants, 25,000 and 0 RSUs with a value
of $41,840 and $0 were granted and compensation expense for RSUs of $111,449 and $8,333, respectively, was incurred. During the three
months ended March 31, 2024 and 2023, $33,953 and $0, respectively, was included in compensation under Research and Development.
As
of March 31, 2024, there was $161,941 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 0.92 years.
A
summary of activity regarding the Restricted Stock Units issued follows:
Schedule of Restricted Stock Units (RSUs)
| |
Number of RSU | | |
Weighted Average
Fair Value Per RSU | |
Outstanding, December 31, 2023 | |
| 24,731 | | |
$ | 11.76 | |
Granted | |
| 25,000 | | |
| 1.68 | |
Vested | |
| (15,625 | ) | |
| 5.84 | |
Outstanding, March 31, 2024 | |
| 34,106 | | |
$ | 7.12 | |
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 $2,250,000 of
units from the Company, with each Unit consisting of (i)
one share of the Company’s common stock, (ii) a warrant to purchase one share of the Company’s common stock exercisable
at a purchase price of $18.80 per share, and (iii) a percentage of equity interest in Diagnostics such that, assuming the sale of all
$2,250,000 of Units, SRO LLC will own a 22% interest in Diagnostics. Pursuant to the terms of the Purchase Agreement,
the Units will be sold at a per Unit price equal to 90% of the VWAP of the Company’s common stock for the five trading days
immediately preceding closing. The parties entered into the Purchase Agreement in anticipation of the Company commencing a rights
offering (the “Rights Offering”) pursuant to which the Company intends to offer a total of $4,500,000
of Units to existing stockholders, which includes the $2,250,000
of Units being sold to SRO LLC, an entity which is controlled by Keith Moore, Executive Chairman of Boustead & Company Limited,
an affiliate of Boustead Securities, LLC (“BSL”).
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 $2,250,000,
which funds will be placed in escrow with Sutter Securities, Inc. (“SSI”), an affiliate of BSL, pursuant to the terms of
an escrow agreement entered into between the Company, Shuttle Diagnostics, Inc., BSL and SSI on February 7, 2024 (the “Escrow
Agreement”). The funds will remain in escrow up until closing on the Rights Offering. In addition, in the event the Company
fails to raise the full $4,500,000 in
the Rights Offering, SRO LLC agreed to a backstop commitment pursuant to which it would have the right to purchase any remaining
Units not purchased by existing Company stockholders in the Rights Offering, up to an additional $2,250,000 (the
“Back-up Contingency”). Unless
the parties waive the conditions to closing, in the event the full $4,500,000 is not raised, whether through SRO LLC or through the
Company’s existing stockholders, the Company will not close on the offering and any funds raised and held in escrow will be
returned to investors.
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 $112,500 upon the earlier of the Company filing
the registration statement on Form S-1 registering the Rights Offering or upon such date as the Company terminates the Rights Offering,
a commission equal 8% of the gross proceeds disbursed to the Company upon closing the Rights Offering, and $40,000 in diligence
and related expenses.
As
of March 31, 2024, the Company has incurred $82,000 in costs directly related to the planned Rights Offering. The Company has deferred
these costs as other current assets in the condensed consolidated balance sheet and will recognize the deferred costs as a reduction
in proceeds obtained upon the closing of the Rights Offering, or as an expense in the event the Rights Offering is not consummated.
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 127,260 shares of common stock,
with an exercise price of $18.80 per share, valued at inception at $1,189,000 and as of March 31, 2024, at $214,615. The Company determined
our derivative liabilities from the warrants issued in relation to the Alto Convertible Note do not satisfy the classification as equity
instruments due to the existence of a certain net cash settlement provision that is 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.
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 ($2,631,000
included in debt discount) and March 31, 2024
($216,650).
Key inputs for the simulation are summarized below. The Monte Carlo simulation uses an implied VWAP for the January 11, 2023 valuation
date. The implied VWAP was backsolved by setting the summation of the parts (e.g., derivatives and debt without derivatives) equal to
the cash proceeds. The simulation was then iterated and manipulated to solve for the implied share price, which was approximately $12.64
per share (or an approximate 14%
discount to the quoted market VWAP on January 11, 2023).
The
key inputs for the Monte Carlo simulation as of March 31, 2024, were as follows:
Schedule of Monte Carlo Simulation Assumption
Net cash settlement and down round key valuation inputs -
warrants* | |
| |
Annualized volatility | |
| 67.19% - 72.53 | % |
Risk-free interest rate | |
| 4.40% - 5.47 | % |
Quoted VWAP* | |
$ | 3.28 | |
Exercise price | |
$ | 18.80 | |
Probability assessment | |
| 5% - 25 | % |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0.17 - 2.79 | |
Acceleration option key valuation inputs* | |
| |
Annualized volatility | |
| 48.36%
- 54.75 | % |
Risk-free interest rate | |
| 4.94% - 5.49 | % |
Quoted VWAP* | |
$ | 3.28 | |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0 - 0.95 | |
The
following table summarizes the changes in the derivative liabilities:
Schedule of Derivative Liabilities
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
| |
Warrants | | |
Accelerated Feature | |
Balance - December 31, 2023 | |
$ | 410,660 | | |
$ | 3,852 | |
Gain on change in fair value | |
| (196,045 | ) | |
| (1,817 | ) |
Balance - March 31, 2024 | |
$ | 214,615 | | |
$ | 2,035 | |
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 $0
and $300,000,
respectively.
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 $600,000
to the Investor, which funds will be held as collateral to the balance owed under the Alto Convertible Note, and received a waiver
from the Investor related to the default.
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 $10 million.
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 $2.3 million, payable in stages and based upon services performed during the Term of the study.
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.
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.
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.
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.
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.
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.
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.
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:
Exhibit
No. |
|
Description
of Exhibit |
3.1 |
|
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registration Statement on Form S-1 (File No. 333-265429) filed on June 3, 2022). |
3.2 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, effective March 30, 2022 (incorporated by reference to Exhibit 3.2 to the Registration Statement on Form S-1 (File No. 333-265429) filed on June 3, 2022). |
3.3 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, effective June 22, 2022 (incorporated by reference to Exhibit 3.5 to the Registration Statement on Form S-1/A (File No. 333-265429) filed on June 23, 2022). |
3.4 |
|
Second Amended and Restated By-Laws (incorporated by reference to Exhibit 3.1 to the current Report on Form 8-K filed on November 1, 2022). |
3.5 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, effective August 13, 2024 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on August 7, 2024). |
4.1 |
|
Form of Convertible Note, dated January 11, 2023, issued by Shuttle Pharmaceuticals Holdings, Inc. to Alto Capital Master Fund, SPC – Segregated Master Portfolio B (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed January 12, 2023). |
4.2 |
|
Form of Warrant, dated January 11, 2023, issued by Shuttle Pharmaceuticals Holdings, Inc. to Alto Capital Master Fund, SPC – Segregated Master Portfolio B (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed January 12, 2023). |
10.1 |
|
Asset Purchase Agreement, dated January 30, 2024, by and between Shuttle Pharmaceuticals Holdings, Inc., Alan Kozikowski and Werner Tueckmantel (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on February 5, 2024). |
10.2 |
|
Securities Purchase Agreement, dated February 7, 2024, between Shuttle Pharmaceuticals Holdings, Inc., Shuttle Diagnostics, Inc. and SRO, LLC (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on February 13, 2024). |
10.3 |
|
Placement Agent and Advisory Services Agreement, dated February 7, 2024, between Shuttle Pharmaceuticals Holdings, Inc. and Boustead Securities, LLC (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on February 13, 2024). |
10.4 |
|
Offering Deposit Account Agency Agreement, dated February 7, 2024, between Shuttle Pharmaceuticals Holdings, Inc., Boustead Securities, LLC and Sutter Securities Inc. (incorporated by reference to Exhibit 10.3 to the Current Report on From 8-K filed on February 13, 2024). |
10.5 |
|
Amendment Agreement, dated August 6, 2024, between Shuttle Pharmaceuticals Holdings, Inc., Suttle Pharmaceuticals, 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 on August 7, 2024). |
10.6 |
|
Work Order, dated August 8, 2024, between Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on August 14, 2024). |
10.7 |
|
Master Services Agreement, dated November 1, 2018, between Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc. (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on August 14, 2024). |
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 |
|
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101.CAL |
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104 |
|
Cover
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*
Filed herewith.
**Furnished
herewith.
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 |
Exhibit
31.1
CERTIFICATION
I,
Anatoly Dritschilo, M.D., certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q/A Pursuant to Rule 15d-2 under the Securities Exchange Act of 1934 for the period ended
March 31, 2024 of Shuttle Pharmaceuticals Holdings, Inc. (the “registrant”);
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
September 3, 2024 |
/s/
Anatoly Dritschilo |
|
Anatoly
Dritschilo, M.D. |
|
Chief
Executive Officer
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
I,
Timothy J. Lorber, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q/A Pursuant to Rule 15d-2 under the Securities Exchange Act of 1934 for the period ended
March 31, 2024 of Shuttle Pharmaceuticals Holdings, Inc. (the “registrant”);
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
September 3, 2024 |
/s/
Timothy J. Lorber |
|
Timothy J. Lorber |
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Shuttle Pharmaceuticals Holdings, Inc. (the “Company”) on Form 10-Q/A pursuant to Rule
15d-2 under the Securities Exchange Act of 1934 for the period ended March 31, 2024, as filed with the Securities and Exchange Commission
on the date hereof (the “Report”), I, Anatoly Dritschilo, M.D., Chief Executive Officer of the Company, certify, pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
September 3, 2024
|
/s/
Anatoly Dritschilo |
|
Anatoly
Dritschilo, M.D. |
|
Chief
Executive Officer
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Shuttle Pharmaceuticals Holdings, Inc. (the “Company”) on Form 10-Q/A pursuant to Rule
15d-2 under the Securities Exchange Act of 1934 for the period ended March 31, 2024, as filed with the Securities and Exchange Commission
on the date hereof (the “Report”), I, Timothy J. Lorber, Chief Financial Officer of the Company, certify, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
September 3, 2024
|
/s/
Timothy J. Lorber |
|
Timothy J. Lorber |
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
v3.24.2.u1
Cover - shares
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3 Months Ended |
|
Mar. 31, 2024 |
Sep. 03, 2024 |
Cover [Abstract] |
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Amendment Description |
This
Amendment No. 1 to Form 10-Q/A (the “Amendment No.1”) amends the Quarterly Report on Form 10-Q of Shuttle
Pharmaceuticals Holdings, Inc. (the “Company”) for the fiscal quarter ended March 31, 2024, as filed with the Securities
and Exchange Commission, or the SEC, on May 13, 2024 (the “Original Filing”). As previously reported, following the
entry of a cease-and-desist order entered on May 3, 2024 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 of our board of directors, in consultation with our current auditor, Forvis Mazars, LLP, concluded 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 and the quarterly periods included in the Company’s Form 10-K, and
the Original Filing require restatement and are not reliable.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
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|
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Entity File Number |
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|
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Entity Registrant Name |
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
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Entity Central Index Key |
0001757499
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 1,398,628
|
$ 2,576,416
|
Prepaid expenses |
129,642
|
114,473
|
Marketable securities |
2,789,251
|
2,887,215
|
Accrued interest income |
11,964
|
14,901
|
Other current assets |
81,534
|
|
Total current assets |
4,411,019
|
5,593,005
|
Property and equipment, net |
22,915
|
24,827
|
Operating lease right-of-use asset |
319,987
|
333,904
|
Total Assets |
4,753,921
|
5,951,736
|
Current Liabilities |
|
|
Accrued interest payable |
143,676
|
110,453
|
Convertible notes payable, net |
941,398
|
595,999
|
Derivative liability |
2,035
|
|
Operating lease liability |
54,552
|
52,479
|
Total Current Liabilities |
1,489,217
|
1,042,237
|
Convertible notes payable non-current, net |
|
135,089
|
Derivative liabilities non-current |
214,615
|
414,512
|
Operating lease liability non-current |
288,602
|
304,127
|
Total Liabilities |
1,992,434
|
1,895,965
|
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; 2,102,511 and 2,008,689 shares issued and outstanding, respectively |
21
|
20
|
Additional paid in capital, as restated |
29,925,801
|
29,489,055
|
Accumulated deficit, as restated |
(27,164,335)
|
(25,433,304)
|
Total Stockholders’ Equity |
2,761,487
|
4,055,771
|
Total Liabilities and Stockholders’ Equity |
4,753,921
|
5,951,736
|
Nonrelated Party [Member] |
|
|
Current Liabilities |
|
|
Accounts payable and accrued expenses |
347,556
|
282,860
|
Related Party [Member] |
|
|
Current Liabilities |
|
|
Accounts payable and accrued expenses |
|
$ 446
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.00001
|
$ 0.00001
|
Preferred stock, liquidation preference per share |
$ 1,000
|
$ 1,000
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.00001
|
$ 0.00001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
2,102,511
|
2,008,689
|
Common stock, shares outstanding |
2,102,511
|
2,008,689
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
Revenue |
|
|
Operating expenses |
|
|
Research and development |
586,104
|
921,801
|
General and administrative |
324,609
|
255,355
|
Legal and professional |
474,134
|
367,624
|
Total operating expenses |
1,384,847
|
1,544,780
|
Loss from operations |
(1,384,847)
|
(1,544,780)
|
Other income (expense) |
|
|
Interest income |
21,453
|
16,688
|
Finance fee |
|
(104,245)
|
Change in fair value of derivative liabilities |
197,862
|
1,241,000
|
Gain on sale of marketable securities |
4,037
|
|
Change in fair value of marketable securities |
(706)
|
38,062
|
Loss on settlement of convertible debt |
(71,315)
|
(18,254)
|
Total other income (expense) |
(346,184)
|
569,683
|
Net loss attributable to common stockholders |
$ (1,731,031)
|
$ (975,097)
|
Weighted average common shares outstanding - basic |
2,075,745
|
1,704,517
|
Weighted average common shares outstanding - diluted |
2,075,745
|
1,704,517
|
Net loss per shares - basic |
$ (0.83)
|
$ (0.57)
|
Net loss per shares - diluted |
$ (0.83)
|
$ (0.57)
|
Related Party [Member] |
|
|
Other income (expense) |
|
|
Interest expense |
|
$ (4,237)
|
Nonrelated Party [Member] |
|
|
Other income (expense) |
|
|
Interest expense |
$ (497,515)
|
$ (599,331)
|
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v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 17
|
$ 26,518,433
|
$ (18,840,581)
|
$ 7,677,869
|
Balance, shares at Dec. 31, 2022 |
1,700,414
|
|
|
|
Common stock issued for conversion of accrued interest and principal |
|
104,547
|
|
104,547
|
Common stock issued for conversion of accrued interest and principal, shares |
6,375
|
|
|
|
Stock-based compensation |
|
8,333
|
|
8,333
|
Net loss |
|
|
(975,097)
|
(975,097)
|
Warrants issued for financing costs |
|
90,816
|
|
90,816
|
Balance at Mar. 31, 2023 |
$ 17
|
26,722,129
|
(19,815,678)
|
6,906,468
|
Balance, shares at Mar. 31, 2023 |
1,706,789
|
|
|
|
Balance at Dec. 31, 2023 |
$ 20
|
29,489,055
|
(25,433,304)
|
4,055,771
|
Balance, shares at Dec. 31, 2023 |
2,008,689
|
|
|
|
Common stock issued for conversion of accrued interest and principal |
$ 1
|
325,297
|
|
325,298
|
Common stock issued for conversion of accrued interest and principal, shares |
78,197
|
|
|
|
Common stock issued for restricted stock units |
|
|
|
|
Common stock issued for restricted stock units, shares |
15,625
|
|
|
|
Stock-based compensation |
|
111,449
|
|
111,449
|
Net loss |
|
|
(1,731,031)
|
(1,731,031)
|
Balance at Mar. 31, 2024 |
$ 21
|
$ 29,925,801
|
$ (27,164,335)
|
$ 2,761,487
|
Balance, shares at Mar. 31, 2024 |
2,102,511
|
|
|
|
X |
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (1,731,031)
|
$ (975,097)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
1,912
|
1,488
|
Change in fair value of derivative liability |
(197,862)
|
(1,241,000)
|
Amortization of debt discount and finance fees |
445,509
|
567,297
|
Gain on marketable securities |
(4,037)
|
|
Change in fair value of marketable securities |
706
|
(38,062)
|
Accrued interest settled with common stock |
18,783
|
20,142
|
Loss on settlement of convertible debt |
71,315
|
18,254
|
Stock-based compensation |
111,449
|
8,333
|
Changes in operating assets and liabilities: |
|
|
Accrued interest income |
2,937
|
(7,023)
|
Prepaid expenses |
(15,169)
|
(42,687)
|
Accounts payable and accrued expenses |
23,162
|
330,729
|
Accounts payable and accrued expenses - related parties |
(446)
|
(12,500)
|
Accrued interest payable |
33,223
|
116,051
|
Accrued interest payable - related parties |
|
(74,807)
|
Other assets |
|
(7,206)
|
Change in operating lease asset and liabilities |
466
|
(1,894)
|
Net cash used in operating activities |
(1,239,083)
|
(1,337,982)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Investment in marketable securities |
(18,705)
|
(2,953,709)
|
Proceeds from disposition of marketable securities |
120,000
|
|
Net cash used in investing activities |
101,295
|
(2,953,709)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Repayment of note payable-related party |
|
(546,244)
|
Proceeds from convertible notes payable and warrants |
|
3,935,000
|
Payment for finance costs related to convertible note payable |
|
(345,000)
|
Payment for finance costs |
(40,000)
|
|
Net cash provided by financing activities |
(40,000)
|
3,043,756
|
Net change in cash and cash equivalents |
(1,177,788)
|
(1,247,935)
|
Cash and cash equivalents, beginning of period |
2,576,416
|
8,417,203
|
Cash and cash equivalents, end of period |
1,398,628
|
7,169,268
|
Cash paid for: |
|
|
Interest |
|
79,044
|
Income taxes |
|
|
Supplemental non-cash financing activities: |
|
|
Common stock issued for settlement of debt |
325,298
|
104,547
|
Finance costs accrued in accounts payable |
41,534
|
|
Warrants issued for financing fees, net of issuance fees of $0 and $8,727, respectively |
|
$ 90,816
|
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v3.24.2.u1
Organization and Liquidity
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Liquidity |
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 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. All share numbers referenced herein reflect a 1-for-8 reverse split of our common stock on a post-split basis, which
was effective as of August 13, 2024 (see Note 2).
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 $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. On July 12, 2024, the Company informed the investor of its convertible
note that the Company’s expected restatement of its financial statements for the years ended December 31, 2022 and 2023 constituted
an event of default under the terms of the convertible note. On August 6, 2024, the Company paid $0.6 million to the investor of the convertible
note and received a waiver from the investor related to the default. The funds paid are restricted and will be held as collateral to the
balance owed under the convertible note (see Note 9). 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
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,
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 $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). The Reverse Stock Split also resulted in an adjustment to the consolidated balance
sheet for the period ended March 31, 2024 and the year ended December 31, 2023 within additional paid in capital of $147 and $141,
respectively, and an offsetting adjustment to the carrying value of common stock. All share, option, warrant and per share amounts
(except our authorized outstanding) have been retroactively restated in these financial statements and related
disclosures. The effect of the Reverse Stock Split has been included in Note 2 in the
“As Reported” amounts for additional paid in capital.
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v3.24.2.u1
Restatement of Previously Issued Financial Statements
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Changes and Error Corrections [Abstract] |
|
Restatement of Previously Issued Financial Statements |
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:
Schedule
of Restatement On Each Financial Statement
Consolidated Balance Sheet as of March 31, 2024 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,980,109 | | |
| 9,945,692 | | |
| 29,925,801 | |
Accumulated deficit | |
| (17,218,643 | ) | |
| (9,945,692 | ) | |
| (27,164,335 | ) |
Consolidated Balance Sheet as of December 31, 2023 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,543,363 | | |
| 9,945,692 | | |
| 29,489,055 | |
Accumulated deficit | |
| (15,487,612 | ) | |
| (9,945,692 | ) | |
| (25,433,304 | ) |
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v3.24.2.u1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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.
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:
Schedule of Cash and Cash Equivalents
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash | |
$ | 364,069 | | |
$ | 1,550,098 | |
Money market funds | |
| 1,034,559 | | |
| 1,026,318 | |
Total cash and cash equivalents | |
$ | 1,398,628 | | |
$ | 2,576,416 | |
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, 2024 was approximately $1.1 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.
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 $2,789,251
and $2,887,215
as of March 31, 2024 and December 31, 2023, respectively. During the three months ended March 31, 2024 and 2023, the Company
recognized interest income of $13,651
and $16,688,
realized gains of $4,037
and $0,
and unrealized loss of $706
and gain of $38,062,
respectively.
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.
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:
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Total Assets | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 214,615 | | |
$ | — | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 2,035 | | |
| — | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 216,650 | | |
$ | — | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Total Assets | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 410,660 | | |
$ | 410,660 | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 3,852 | | |
| 3,852 | |
Derivative Liability | |
| - | | |
| - | | |
| 3,852 | | |
| 3,852 | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 414,512 | | |
$ | 414,512 | |
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.
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 $165 thousand and
$385 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 Common Stock
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.
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.
For
the three months ended March 31, 2024 and 2023, 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, | |
| |
2024 | | |
2023 | |
Convertible notes (Note 6) | |
| 107,429 | | |
| 236,641 | |
Warrant (Note 7) | |
| 184,000 | | |
| 184,000 | |
Restricted stock units (Note 7) | |
| 34,106 | | |
| 2,966 | |
| |
| 325,535 | | |
| 423,607 | |
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.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.2.u1
Leases
|
3 Months Ended |
Mar. 31, 2024 |
Leases |
|
Leases |
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 $6,480. The laboratory lease commenced on October 1,
2018 and expired on October 31, 2023.
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 per month 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, and the expiry date of the LOC is March 1, 2025.
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
| |
2024 | | |
2023 | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Operating lease cost | |
$ | 22,947 | | |
$ | 17,544 | |
Variable lease cost | |
| 10,440 | | |
| — | |
Sublease income | |
| (2,163 | ) | |
| (2,121 | ) |
Total lease cost | |
$ | 31,224 | | |
$ | 15,423 | |
| |
| | | |
| | |
Other information | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 22,482 | | |
$ | 19,440 | |
| |
| | | |
| | |
Weighted-average remaining lease term - operating leases (year) | |
| 4.42 | | |
| 0.56 | |
Weighted-average discount rate - operating leases | |
| 10.48 | % | |
| 10 | % |
Future
non-cancelable minimum lease payments under the operating lease liability as of March 31, 2024, are as follows:
Schedule
of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability
Years ended December 31, | |
| |
2024 (excluding the three months ended March 31, 2024) | |
$ | 69,020 | |
2025 | |
| 94,246 | |
2026 | |
| 97,074 | |
2027 | |
| 99,986 | |
2028 | |
| 68,235 | |
Total future minimum lease payments | |
| 428,561 | |
Less: imputed interest | |
| (85,407 | ) |
Present value of payments | |
$ | 343,154 | |
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.2.u1
Notes Payable-Related Party
|
3 Months Ended |
Mar. 31, 2024 |
Notes Payable-related Party |
|
Notes Payable-Related Party |
Note
5 – Notes Payable-Related Party
During
the three months ended March 31, 2024 and 2023 the Company incurred $0 and $4,237 in interest expense. During the three months ended
March 31, 2024 and 2023 principal payments of $and
$
and accrued interest of $
and $
were paid, respectively, on notes to related parties. The principal and accrued interest
for these notes were fully paid by December 31, 2023.
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v3.24.2.u1
Convertible Notes and Notes Payable
|
3 Months Ended |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
Convertible Notes and Notes Payable |
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 $4,300,000
convertible note (the “Alto Convertible Note”) and warrant (the “Warrant”) to purchase 127,260
shares of common stock, exercisable at $18.80
per share, in exchange for gross proceeds of $3,935,000 (the “Investment Amount”) (See Note 8). The Company determined that the Warrant contains a net cash settlement
feature at inception and categorized the Warrant as a liability in the accompanying condensed consolidated financial statements. The
Alto Convertible Note matures on March 11, 2025, but may be extended at the option of the noteholder. The Alto Convertible Note
amortizes on a monthly basis and the Company can make such monthly amortization payments in cash or, subject to certain equity
conditions, in registered shares of common stock or a combination thereof. Installments may be deferred by the noteholder, resulting
in a variable interest rate. However, the effective interest rate is approximately 244%
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 is convertible into shares of common stock at a price per share equal to the lower of (i) $18.80, (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 may convert at any time at a fixed price of $18.80 per share. The noteholder has an acceleration
of installment amount conversion option (the “Acceleration Option”), whereby the noteholder, with certain share
percentage limitations, can 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 has determined the Acceleration Option 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 $1,442,000
at inception, using a Monte Carlo simulation model (Note 8). The Convertible Note is repayable over 26 months and bears interest at the rate of 5%
per annum. Additionally, the note contains certain redemption options and “Make Whole” provisions.
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 $10.0
million in convertible notes and warrants on substantially the same terms as the Alto Convertible Note and Warrant, excluding the Springing
DACA requirement, with such option to be effective through December 31, 2025. The agreement offers the investor an opportunity to participate
in future capital raises at substantially similar terms as the January 11, 2023 agreement. The Company expects 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 is 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 is being amortized to interest expense over the term of the Alto
Convertible Note.
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.
During
the three months ended March 31, 2023, the Company recorded interest expense of $599,331,
which included amortization of debt discount of $463,052
as interest expense and settlement of $20,142
of accrued interest and $66,150
of principal by issuing 6,375 shares of Common Stock.
As
of March 31, 2024, the outstanding principal for the convertible note was $2,019,656 and the debt discount remaining was $1,078,258,
with a net convertible note carrying value of $941,398
as of March 31, 2024.
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.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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Stockholders’ Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
7 – Stockholders’ Equity
Common
Stock
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. |
|
● |
15,625
shares of common stock issued for vesting of restricted stock units. |
During
the three months ended March 31, 2023, the Company issued:
|
● |
6,375
shares of Common Stock to settle $66,150 of principal and $20,142 of interest on a convertible note and incurred $18,254 of loss
on settlement. |
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 6). In addition, Alto was granted warrants to purchase 127,260 shares of common stock, at an
exercise price of $18.80 per share (Note 6, 8).
A
summary of activity regarding all warrants issued for the three months ended March 31, 2024 were as follows:
Schedule of Warrants Activity
| |
Number of | | |
Weighted Average | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | | |
Life (years) | |
Outstanding, December 31, 2023 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.77 | |
Granted | |
| — | | |
| — | | |
| — | |
Outstanding, March 31, 2024 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.53 | |
The
intrinsic value of the warrants as of March 31, 2024 is $0. 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 3,000,000 shares of our common stock for issuance under the 2018 Equity Incentive Plan. As of
March 31, 2024, 109,773 shares have been granted under the 2018 Equity Incentive Plan, of which 75,673 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.
During
the three months ended March 31, 2024 and 2023, pursuant to agreements with officers and consultants, 25,000 and 0 RSUs with a value
of $41,840 and $0 were granted and compensation expense for RSUs of $111,449 and $8,333, respectively, was incurred. During the three
months ended March 31, 2024 and 2023, $33,953 and $0, respectively, was included in compensation under Research and Development.
As
of March 31, 2024, there was $161,941 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 0.92 years.
A
summary of activity regarding the Restricted Stock Units issued follows:
Schedule of Restricted Stock Units (RSUs)
| |
Number of RSU | | |
Weighted Average
Fair Value Per RSU | |
Outstanding, December 31, 2023 | |
| 24,731 | | |
$ | 11.76 | |
Granted | |
| 25,000 | | |
| 1.68 | |
Vested | |
| (15,625 | ) | |
| 5.84 | |
Outstanding, March 31, 2024 | |
| 34,106 | | |
$ | 7.12 | |
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 $2,250,000 of
units from the Company, with each Unit consisting of (i)
one share of the Company’s common stock, (ii) a warrant to purchase one share of the Company’s common stock exercisable
at a purchase price of $18.80 per share, and (iii) a percentage of equity interest in Diagnostics such that, assuming the sale of all
$2,250,000 of Units, SRO LLC will own a 22% interest in Diagnostics. Pursuant to the terms of the Purchase Agreement,
the Units will be sold at a per Unit price equal to 90% of the VWAP of the Company’s common stock for the five trading days
immediately preceding closing. The parties entered into the Purchase Agreement in anticipation of the Company commencing a rights
offering (the “Rights Offering”) pursuant to which the Company intends to offer a total of $4,500,000
of Units to existing stockholders, which includes the $2,250,000
of Units being sold to SRO LLC, an entity which is controlled by Keith Moore, Executive Chairman of Boustead & Company Limited,
an affiliate of Boustead Securities, LLC (“BSL”).
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 $2,250,000,
which funds will be placed in escrow with Sutter Securities, Inc. (“SSI”), an affiliate of BSL, pursuant to the terms of
an escrow agreement entered into between the Company, Shuttle Diagnostics, Inc., BSL and SSI on February 7, 2024 (the “Escrow
Agreement”). The funds will remain in escrow up until closing on the Rights Offering. In addition, in the event the Company
fails to raise the full $4,500,000 in
the Rights Offering, SRO LLC agreed to a backstop commitment pursuant to which it would have the right to purchase any remaining
Units not purchased by existing Company stockholders in the Rights Offering, up to an additional $2,250,000 (the
“Back-up Contingency”). Unless
the parties waive the conditions to closing, in the event the full $4,500,000 is not raised, whether through SRO LLC or through the
Company’s existing stockholders, the Company will not close on the offering and any funds raised and held in escrow will be
returned to investors.
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 $112,500 upon the earlier of the Company filing
the registration statement on Form S-1 registering the Rights Offering or upon such date as the Company terminates the Rights Offering,
a commission equal 8% of the gross proceeds disbursed to the Company upon closing the Rights Offering, and $40,000 in diligence
and related expenses.
As
of March 31, 2024, the Company has incurred $82,000 in costs directly related to the planned Rights Offering. The Company has deferred
these costs as other current assets in the condensed consolidated balance sheet and will recognize the deferred costs as a reduction
in proceeds obtained upon the closing of the Rights Offering, or as an expense in the event the Rights Offering is not consummated.
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
Derivative Liabilities
|
3 Months Ended |
Mar. 31, 2024 |
Derivative Liabilities |
|
Derivative Liabilities |
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 127,260 shares of common stock,
with an exercise price of $18.80 per share, valued at inception at $1,189,000 and as of March 31, 2024, at $214,615. The Company determined
our derivative liabilities from the warrants issued in relation to the Alto Convertible Note do not satisfy the classification as equity
instruments due to the existence of a certain net cash settlement provision that is 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.
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 ($2,631,000
included in debt discount) and March 31, 2024
($216,650).
Key inputs for the simulation are summarized below. The Monte Carlo simulation uses an implied VWAP for the January 11, 2023 valuation
date. The implied VWAP was backsolved by setting the summation of the parts (e.g., derivatives and debt without derivatives) equal to
the cash proceeds. The simulation was then iterated and manipulated to solve for the implied share price, which was approximately $12.64
per share (or an approximate 14%
discount to the quoted market VWAP on January 11, 2023).
The
key inputs for the Monte Carlo simulation as of March 31, 2024, were as follows:
Schedule of Monte Carlo Simulation Assumption
Net cash settlement and down round key valuation inputs -
warrants* | |
| |
Annualized volatility | |
| 67.19% - 72.53 | % |
Risk-free interest rate | |
| 4.40% - 5.47 | % |
Quoted VWAP* | |
$ | 3.28 | |
Exercise price | |
$ | 18.80 | |
Probability assessment | |
| 5% - 25 | % |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0.17 - 2.79 | |
* | | Based on a Monte
Carlo simulation analysis of 250,000 iterations |
Acceleration option key valuation inputs* | |
| |
Annualized volatility | |
| 48.36%
- 54.75 | % |
Risk-free interest rate | |
| 4.94% - 5.49 | % |
Quoted VWAP* | |
$ | 3.28 | |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0 - 0.95 | |
* | | Based on a Monte Carlo simulation analysis of 250,000 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 | | |
Accelerated Feature | |
Balance - December 31, 2023 | |
$ | 410,660 | | |
$ | 3,852 | |
Gain on change in fair value | |
| (196,045 | ) | |
| (1,817 | ) |
Balance - March 31, 2024 | |
$ | 214,615 | | |
$ | 2,035 | |
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v3.24.2.u1
Related Party Transactions
|
3 Months Ended |
Mar. 31, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
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 $0
and $300,000,
respectively.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
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 $600,000
to the Investor, which funds will be held as collateral to the balance owed under the Alto Convertible Note, and received a waiver
from the Investor related to the default.
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 $10 million.
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 $2.3 million, payable in stages and based upon services performed during the Term of the study.
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
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 |
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 |
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
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:
Schedule of Cash and Cash Equivalents
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash | |
$ | 364,069 | | |
$ | 1,550,098 | |
Money market funds | |
| 1,034,559 | | |
| 1,026,318 | |
Total cash and cash equivalents | |
$ | 1,398,628 | | |
$ | 2,576,416 | |
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, 2024 was approximately $1.1 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.
|
Marketable Securities |
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 $2,789,251
and $2,887,215
as of March 31, 2024 and December 31, 2023, respectively. During the three months ended March 31, 2024 and 2023, the Company
recognized interest income of $13,651
and $16,688,
realized gains of $4,037
and $0,
and unrealized loss of $706
and gain of $38,062,
respectively.
|
Fair Value of Financial Instruments |
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.
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:
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Total Assets | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 214,615 | | |
$ | — | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 2,035 | | |
| — | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 216,650 | | |
$ | — | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Total Assets | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 410,660 | | |
$ | 410,660 | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 3,852 | | |
| 3,852 | |
Derivative Liability | |
| - | | |
| - | | |
| 3,852 | | |
| 3,852 | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 414,512 | | |
$ | 414,512 | |
|
Derivative Financial Instruments |
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.
|
Warrants |
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
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 $165 thousand and
$385 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 Common Stock |
Net
Loss Per Common Stock
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.
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.
For
the three months ended March 31, 2024 and 2023, 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, | |
| |
2024 | | |
2023 | |
Convertible notes (Note 6) | |
| 107,429 | | |
| 236,641 | |
Warrant (Note 7) | |
| 184,000 | | |
| 184,000 | |
Restricted stock units (Note 7) | |
| 34,106 | | |
| 2,966 | |
| |
| 325,535 | | |
| 423,607 | |
|
Deferred Offering Costs |
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 |
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.
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v3.24.2.u1
Restatement of Previously Issued Financial Statements (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Changes and Error Corrections [Abstract] |
|
Schedule of Restatement On Each Financial Statement |
The following tables summarize the effect of the restatement on each financial statement line item as of the dates indicated:
Schedule
of Restatement On Each Financial Statement
Consolidated Balance Sheet as of March 31, 2024 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,980,109 | | |
| 9,945,692 | | |
| 29,925,801 | |
Accumulated deficit | |
| (17,218,643 | ) | |
| (9,945,692 | ) | |
| (27,164,335 | ) |
Consolidated Balance Sheet as of December 31, 2023 | |
As Reported | | |
Adjustment | | |
As Restated | |
Additional paid in capital | |
| 19,543,363 | | |
| 9,945,692 | | |
| 29,489,055 | |
Accumulated deficit | |
| (15,487,612 | ) | |
| (9,945,692 | ) | |
| (25,433,304 | ) |
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v3.24.2.u1
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Cash and Cash Equivalents |
Schedule of Cash and Cash Equivalents
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash | |
$ | 364,069 | | |
$ | 1,550,098 | |
Money market funds | |
| 1,034,559 | | |
| 1,026,318 | |
Total cash and cash equivalents | |
$ | 1,398,628 | | |
$ | 2,576,416 | |
|
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis |
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:
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis
March 31, 2024 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Total Assets | |
$ | 2,789,251 | | |
$ | — | | |
$ | — | | |
$ | 2,789,251 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 214,615 | | |
$ | — | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 2,035 | | |
| — | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 216,650 | | |
$ | — | |
December 31, 2023 | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Carrying Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Securities: | |
| | | |
| | | |
| | | |
| | |
United States Treasury Bonds | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Total Assets | |
$ | 2,887,215 | | |
$ | — | | |
$ | — | | |
$ | 2,887,215 | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Derivative Liability - Warrants | |
$ | — | | |
$ | — | | |
$ | 410,660 | | |
$ | 410,660 | |
Derivative Liability - Accelerated feature | |
| — | | |
| — | | |
| 3,852 | | |
| 3,852 | |
Derivative Liability | |
| - | | |
| - | | |
| 3,852 | | |
| 3,852 | |
Total Liabilities | |
$ | — | | |
$ | — | | |
$ | 414,512 | | |
$ | 414,512 | |
|
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share |
For
the three months ended March 31, 2024 and 2023, 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, | |
| |
2024 | | |
2023 | |
Convertible notes (Note 6) | |
| 107,429 | | |
| 236,641 | |
Warrant (Note 7) | |
| 184,000 | | |
| 184,000 | |
Restricted stock units (Note 7) | |
| 34,106 | | |
| 2,966 | |
| |
| 325,535 | | |
| 423,607 | |
|
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v3.24.2.u1
Leases (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Leases |
|
Schedule of Right-of Use Asset and Lease Information about Operating Lease |
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
| |
2024 | | |
2023 | |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Operating lease cost | |
$ | 22,947 | | |
$ | 17,544 | |
Variable lease cost | |
| 10,440 | | |
| — | |
Sublease income | |
| (2,163 | ) | |
| (2,121 | ) |
Total lease cost | |
$ | 31,224 | | |
$ | 15,423 | |
| |
| | | |
| | |
Other information | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 22,482 | | |
$ | 19,440 | |
| |
| | | |
| | |
Weighted-average remaining lease term - operating leases (year) | |
| 4.42 | | |
| 0.56 | |
Weighted-average discount rate - operating leases | |
| 10.48 | % | |
| 10 | % |
|
Schedule of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability |
Future
non-cancelable minimum lease payments under the operating lease liability as of March 31, 2024, are as follows:
Schedule
of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability
Years ended December 31, | |
| |
2024 (excluding the three months ended March 31, 2024) | |
$ | 69,020 | |
2025 | |
| 94,246 | |
2026 | |
| 97,074 | |
2027 | |
| 99,986 | |
2028 | |
| 68,235 | |
Total future minimum lease payments | |
| 428,561 | |
Less: imputed interest | |
| (85,407 | ) |
Present value of payments | |
$ | 343,154 | |
|
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v3.24.2.u1
Stockholders’ Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Schedule of Warrants Activity |
A
summary of activity regarding all warrants issued for the three months ended March 31, 2024 were as follows:
Schedule of Warrants Activity
| |
Number of | | |
Weighted Average | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | | |
Life (years) | |
Outstanding, December 31, 2023 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.77 | |
Granted | |
| — | | |
| — | | |
| — | |
Outstanding, March 31, 2024 | |
| 184,000 | | |
$ | 23.20 | | |
| 2.53 | |
|
Schedule of Restricted Stock Units (RSUs) |
A
summary of activity regarding the Restricted Stock Units issued follows:
Schedule of Restricted Stock Units (RSUs)
| |
Number of RSU | | |
Weighted Average
Fair Value Per RSU | |
Outstanding, December 31, 2023 | |
| 24,731 | | |
$ | 11.76 | |
Granted | |
| 25,000 | | |
| 1.68 | |
Vested | |
| (15,625 | ) | |
| 5.84 | |
Outstanding, March 31, 2024 | |
| 34,106 | | |
$ | 7.12 | |
|
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v3.24.2.u1
Derivative Liabilities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Derivative Liabilities |
|
Schedule of Monte Carlo Simulation Assumption |
The
key inputs for the Monte Carlo simulation as of March 31, 2024, were as follows:
Schedule of Monte Carlo Simulation Assumption
Net cash settlement and down round key valuation inputs -
warrants* | |
| |
Annualized volatility | |
| 67.19% - 72.53 | % |
Risk-free interest rate | |
| 4.40% - 5.47 | % |
Quoted VWAP* | |
$ | 3.28 | |
Exercise price | |
$ | 18.80 | |
Probability assessment | |
| 5% - 25 | % |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0.17 - 2.79 | |
* | | Based on a Monte
Carlo simulation analysis of 250,000 iterations |
Acceleration option key valuation inputs* | |
| |
Annualized volatility | |
| 48.36%
- 54.75 | % |
Risk-free interest rate | |
| 4.94% - 5.49 | % |
Quoted VWAP* | |
$ | 3.28 | |
Illiquidity discount | |
| (16 | )% |
Time period (years) | |
| 0 - 0.95 | |
* | | Based on a Monte Carlo simulation analysis of 250,000 iterations |
|
Schedule of Derivative Liabilities |
The
following table summarizes the changes in the derivative liabilities:
Schedule of Derivative Liabilities
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
| |
Warrants | | |
Accelerated Feature | |
Balance - December 31, 2023 | |
$ | 410,660 | | |
$ | 3,852 | |
Gain on change in fair value | |
| (196,045 | ) | |
| (1,817 | ) |
Balance - March 31, 2024 | |
$ | 214,615 | | |
$ | 2,035 | |
|
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v3.24.2.u1
Organization and Liquidity (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
12 Months Ended |
|
Aug. 13, 2024 |
Aug. 12, 2016 |
Jan. 31, 2023 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Jan. 11, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Net loss |
|
|
|
$ 1,731,031
|
$ 975,097
|
|
|
Revenues |
|
|
|
|
|
|
|
Working capital |
|
|
|
2,900,000
|
|
|
|
Proceeds from convertible debt |
|
|
|
$ 600,000
|
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
|
$ 18.80
|
|
|
|
|
Common stock, shares issued |
2,111,235
|
|
|
2,102,511
|
|
2,008,689
|
|
Common stock, shares outstanding |
2,111,235
|
|
|
2,102,511
|
|
2,008,689
|
|
Adjustments to additional paid in capital other |
|
|
|
$ 147
|
|
$ 141
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Reverse stock split |
1-for-8
reverse stock split
|
|
|
|
|
|
|
Minimum bid price |
$ 1.00
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
|
|
|
|
|
$ 18.80
|
Institutional Investor [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Debt Instrument, Face Amount |
|
|
$ 4,300,000
|
|
|
|
|
Proceeds from Issuance of Warrants |
|
|
$ 3,600,000
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Number of shares issued |
|
5,625,000
|
|
|
|
|
|
Sale of stock membership percentage |
|
100.00%
|
|
|
|
|
|
Reverse stock split |
|
1-for-8 reverse split
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
Common Stock [Member] | Institutional Investor [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Class of Warrant or Right, Outstanding |
|
|
127,260
|
|
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
|
$ 18.80
|
|
|
|
|
X |
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v3.24.2.u1
Schedule of Restatement On Each Financial Statement (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] |
|
|
Additional paid in capital |
$ 29,925,801
|
$ 29,489,055
|
Accumulated deficit |
(27,164,335)
|
(25,433,304)
|
Previously Reported [Member] |
|
|
New Accounting Pronouncements or Change in Accounting Principle [Line Items] |
|
|
Additional paid in capital |
19,980,109
|
19,543,363
|
Accumulated deficit |
(17,218,643)
|
(15,487,612)
|
Revision of Prior Period, Reclassification, Adjustment [Member] |
|
|
New Accounting Pronouncements or Change in Accounting Principle [Line Items] |
|
|
Additional paid in capital |
9,945,692
|
9,945,692
|
Accumulated deficit |
$ (9,945,692)
|
$ (9,945,692)
|
X |
- DefinitionAmount of excess of issue price over par or stated value of stock and from other transaction involving stock or stockholder. Includes, but is not limited to, additional paid-in capital (APIC) for common and preferred stock.
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v3.24.2.u1
Schedule of Cash and Cash Equivalents (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
Cash |
$ 364,069
|
$ 1,550,098
|
Money market funds |
1,034,559
|
1,026,318
|
Total cash and cash equivalents |
$ 1,398,628
|
$ 2,576,416
|
X |
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v3.24.2.u1
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Assets |
|
|
Total Assets |
$ 2,789,251
|
$ 2,887,215
|
Derivative Liability |
2,035
|
|
Total Liabilities |
|
414,512
|
Warrant [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
410,660
|
Accelerated Feature [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
3,852
|
US Treasury Securities [Member] |
|
|
Assets |
|
|
United States Treasury Bonds |
2,789,251
|
2,887,215
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Assets |
|
|
Total Assets |
2,789,251
|
2,887,215
|
Total Liabilities |
|
|
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
|
Fair Value, Inputs, Level 1 [Member] | Accelerated Feature [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] |
|
|
Assets |
|
|
United States Treasury Bonds |
2,789,251
|
2,887,215
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Assets |
|
|
Total Assets |
|
|
Total Liabilities |
|
|
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
|
Fair Value, Inputs, Level 2 [Member] | Accelerated Feature [Member] |
|
|
Assets |
|
|
Derivative Liability |
|
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] |
|
|
Assets |
|
|
United States Treasury Bonds |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Assets |
|
|
Total Assets |
|
|
Total Liabilities |
216,650
|
414,512
|
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] |
|
|
Assets |
|
|
Derivative Liability |
214,615
|
410,660
|
Fair Value, Inputs, Level 3 [Member] | Accelerated Feature [Member] |
|
|
Assets |
|
|
Derivative Liability |
2,035
|
3,852
|
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] |
|
|
Assets |
|
|
United States Treasury Bonds |
|
|
X |
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v3.24.2.u1
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
325,535
|
423,607
|
Convertible Debt Securities [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
107,429
|
236,641
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
184,000
|
184,000
|
Restricted Stock Units (RSUs) [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
34,106
|
2,966
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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v3.24.2.u1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Cash FDIC insured amount |
$ 250,000
|
|
|
Cash, uninsured amount |
1,100,000
|
|
|
Marketable securities, outstanding balance |
2,789,251
|
|
$ 2,887,215
|
Interest income |
13,651
|
$ 16,688
|
|
Marketable securities realized gain loss |
4,037
|
0
|
|
Marketable securities unrealized gain loss |
706
|
38,062
|
|
Share based compensation |
111,449
|
8,333
|
|
Research and Development Expense [Member] |
|
|
|
Share based compensation |
$ 165,000
|
$ 385,000
|
|
X |
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v3.24.2.u1
Schedule of Right-of Use Asset and Lease Information about Operating Lease (Details) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Leases |
|
|
Operating lease cost |
$ 22,947
|
$ 17,544
|
Variable lease cost |
10,440
|
|
Sublease income |
(2,163)
|
(2,121)
|
Total lease cost |
31,224
|
15,423
|
Other information |
|
|
Operating cash flows from operating leases |
$ 22,482
|
$ 19,440
|
Weighted-average remaining lease term - operating leases (year) |
4 years 5 months 1 day
|
6 months 21 days
|
Weighted-average discount rate - operating leases |
10.48%
|
10.00%
|
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v3.24.2.u1
Schedule of Future Non-cancelable Minimum Lease Payments Under Operating Lease Liability (Details)
|
Mar. 31, 2024
USD ($)
|
Leases |
|
2024 (excluding the three months ended March 31, 2024) |
$ 69,020
|
2025 |
94,246
|
2026 |
97,074
|
2027 |
99,986
|
2028 |
68,235
|
Total future minimum lease payments |
428,561
|
Less: imputed interest |
(85,407)
|
Present value of payments |
$ 343,154
|
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v3.24.2.u1
Leases (Details Narrative) - USD ($)
|
|
3 Months Ended |
Feb. 16, 2023 |
Mar. 31, 2023 |
Lessee, Lease, Description [Line Items] |
|
|
Lease payment |
|
$ 6,480
|
Lease expiration term |
|
Oct. 31, 2023
|
Lease Agreement [Member] |
|
|
Lessee, Lease, Description [Line Items] |
|
|
Payments for rent |
$ 7,206
|
|
Lease term |
64 months
|
|
Rent variable rate |
3.00%
|
|
Lease commencement |
commenced June 1, 2023
|
|
Estimated monthly common area maintenance cost |
$ 3,300
|
|
Lease Agreement [Member] | Letter of Credit [Member] |
|
|
Lessee, Lease, Description [Line Items] |
|
|
Payments for rent |
3,891
|
|
Security deposit |
43,234
|
|
Common area maintenance cost |
$ 3,315
|
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v3.24.2.u1
Convertible Notes and Notes Payable (Details Narrative)
|
|
3 Months Ended |
|
|
Jan. 11, 2023
USD ($)
$ / shares
shares
|
Mar. 31, 2024
USD ($)
$ / shares
shares
|
Mar. 31, 2023
USD ($)
shares
|
Dec. 31, 2023
USD ($)
|
Jan. 31, 2023
USD ($)
$ / shares
shares
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Convertible debt |
|
$ 2,019,656
|
|
|
|
Warrants to purchase common stock | shares |
|
|
|
|
127,260
|
Warrants exerciable shares | $ / shares |
|
|
|
|
$ 18.80
|
Proceeds from convertible note payable |
|
|
$ 3,935,000
|
|
|
Convertible notes payable |
|
10,000,000.0
|
|
|
|
Allocation of financing costs |
|
40,000
|
|
|
|
Warrant derivative liability |
|
214,615
|
|
$ 414,512
|
$ 1,189,000
|
Legal fees |
|
474,134
|
367,624
|
|
|
Interest expense debt |
|
$ 445,509
|
$ 463,052
|
|
|
Common stock issued for conversion of convertible debt, shares | shares |
|
78,197
|
6,375
|
|
|
Amortization of Debt Issuance Costs |
|
$ 1,078,258
|
|
|
|
Convertible note payable |
|
941,398
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Debt, principal |
|
$ 235,200
|
$ 66,150
|
|
|
Stock Issued During Period, Shares, New Issues | shares |
|
78,197
|
|
|
|
Accrued interest settled with common stock |
|
$ 18,783
|
$ 20,142
|
|
|
Common stock issued for conversion of convertible debt, shares | shares |
|
|
6,375
|
|
|
Measurement Input, Expected Term [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Expected years |
|
5 years
|
|
|
|
Measurement Input, Price Volatility [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Warrants and rights outstanding measurement input |
|
110
|
|
|
|
Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Warrants and rights outstanding measurement input |
|
3.53
|
|
|
|
Boustead Securities LLC [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Warrants to purchase common stock | shares |
|
8,909
|
|
|
|
Warrants exerciable shares | $ / shares |
|
$ 18.80
|
|
|
|
Payment for placement agent |
|
$ 345,000
|
|
|
|
Fair value of warrants |
|
99,543
|
|
|
|
Allocation of financing costs |
|
232,027
|
|
|
|
Warrant derivative liability |
|
104,245
|
|
|
|
Equity warrant as reduction in additional paid in capital |
|
8,727
|
|
|
|
Interest expense debt |
|
497,515
|
$ 599,331
|
|
|
Debt, principal |
|
235,200
|
66,150
|
|
|
Accrued interest |
|
18,783
|
|
|
|
Accrued interest settled with common stock |
|
|
$ 20,142
|
|
|
Boustead Securities LLC [Member] | Convertible Note [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Fair value of warrants |
|
1,288,543
|
|
|
|
Debt discount |
|
300,000
|
|
|
|
Legal fees |
|
65,000
|
|
|
|
Interest fee |
|
215,000
|
|
|
|
Debt principal amount |
|
1,442,000
|
|
|
|
Interest expense debt |
|
$ 3,310,543
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Convertible debt |
$ 4,300,000
|
|
|
|
|
Warrants to purchase common stock | shares |
127,260
|
|
|
|
|
Warrants exerciable shares | $ / shares |
$ 18.80
|
|
|
|
|
Proceeds from convertible note payable |
$ 3,935,000
|
|
|
|
|
Effective interest rate |
244.00%
|
|
|
|
|
Debt description |
the
Alto Convertible Note is convertible into shares of common stock at a price per share equal to the lower of (i) $18.80, (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 may convert at any time at a fixed price of $18.80 per share.
|
|
|
|
|
Derivative liability |
$ 1,442,000
|
|
|
|
|
Debt interest rate |
5.00%
|
|
|
|
|
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|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Number of Warrants Outstanding, Beginning Balance |
184,000
|
|
Weighted Average Exercise Price, Outstanding Beginning Balance |
$ 23.20
|
|
Weighted Average Life (Years), Outstanding Ending |
2 years 6 months 10 days
|
2 years 9 months 7 days
|
Number of Warrants Outstanding, Beginning Balance |
|
|
Weighted Average Exercise Price, Outstanding Beginning Balance |
|
|
Number of Warrants Outstanding, Ending Balance |
184,000
|
184,000
|
Weighted Average Exercise Price, Outstanding Ending Balance |
$ 23.20
|
$ 23.20
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Schedule of Restricted Stock Units (RSUs) (Details) - Restricted Stock Units (RSUs) [Member]
|
3 Months Ended |
Mar. 31, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of RSUs, Outstanding, Beginning Balance | shares |
24,731
|
Weighted Average Grant Date Fair Value Per RSU, Beginning Balance | $ / shares |
$ 11.76
|
Number of Stock Option Outstanding, Granted | shares |
25,000
|
Weighted Average Exercise Price, Granted | $ / shares |
$ 1.68
|
Number of RSUs, Vested | shares |
(15,625)
|
Weighted Average Grant Date Fair Value Per RSU, Vested | $ / shares |
$ 5.84
|
Number of RSUs, Outstanding, Ending Balance | shares |
34,106
|
Weighted Average Grant Date Fair Value Per RSU, Ending Balance | $ / shares |
$ 7.12
|
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
3 Months Ended |
|
|
Feb. 07, 2024 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Jan. 31, 2023 |
Dec. 31, 2018 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Common stock issued for conversion of convertible debt, shares |
|
78,197
|
6,375
|
|
|
Loss on settlement of convertible debt |
|
$ 71,315
|
$ 18,254
|
|
|
Number of warrants to purchase |
|
|
|
127,260
|
|
Exercise price per share |
|
|
|
$ 18.80
|
|
Aggregate intrinsic value of warrants |
|
$ 0
|
|
|
|
Number of shares vested under plan |
|
75,673
|
|
|
|
Restricted stock award granted value |
|
|
|
|
|
Share based compensation |
|
111,449
|
8,333
|
|
|
Sale of stock consideration received per transaction |
$ 2,250,000
|
|
|
|
|
Share based compensation arrangement by share based payment award description |
(i)
one share of the Company’s common stock, (ii) a warrant to purchase one share of the Company’s common stock exercisable
at a purchase price of $18.80 per share, and (iii) a percentage of equity interest in Diagnostics such that, assuming the sale of all
$2,250,000 of Units, SRO LLC will own a 22% interest in Diagnostics
|
|
|
|
|
Proceeds from issuance of common stock |
$ 4,500,000
|
|
|
|
|
Direct cost |
|
82,000
|
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Escrow deposit |
2,250,000
|
|
|
|
|
Right offering |
4,500,000
|
|
|
|
|
Escrow deposit |
$ 2,250,000
|
|
|
|
|
Initial public offering description |
Unless
the parties waive the conditions to closing, in the event the full $4,500,000 is not raised, whether through SRO LLC or through the
Company’s existing stockholders, the Company will not close on the offering and any funds raised and held in escrow will be
returned to investors
|
|
|
|
|
Commitment fee |
$ 112,500
|
|
|
|
|
Related expense |
$ 40,000
|
|
|
|
|
Research and Development Expense [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Share based compensation |
|
165,000
|
385,000
|
|
|
Compensation under research and development |
|
$ 33,953
|
0
|
|
|
2018 Equity Incentive Plan [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Common stock reserved for future issuance |
|
|
|
|
3,000,000
|
Share granted under equity incentive plan |
|
109,773
|
|
|
|
Alto Convertible Note [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of warrants to purchase |
|
|
|
8,909
|
|
Exercise price per share |
|
|
|
$ 18.80
|
|
Restricted Stock [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Common stock issued for conversion of convertible debt, shares |
|
15,625
|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Share based compensation |
|
$ 111,449
|
$ 8,333
|
|
|
Unrecognized compensation cost |
|
$ 161,941
|
|
|
|
Weighted average term |
|
11 months 1 day
|
|
|
|
Restricted Stock Units (RSUs) [Member] | Directors and Officers [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Restricted stock award granted shares |
|
25,000
|
0
|
|
|
Restricted stock award granted value |
|
$ 41,840
|
$ 0
|
|
|
Common Stock [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Common stock issued for conversion of convertible debt, shares |
|
|
6,375
|
|
|
Debt, principal |
|
235,200
|
$ 66,150
|
|
|
Accrued interest settled with common stock |
|
18,783
|
20,142
|
|
|
Loss on settlement of convertible debt |
|
$ 71,315
|
$ 18,254
|
|
|
Restricted stock award granted shares |
|
15,625
|
|
|
|
Restricted stock award granted value |
|
|
|
|
|
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Schedule of Monte Carlo Simulation Assumption (Details)
|
3 Months Ended |
|
Mar. 31, 2024
$ / shares
|
Jan. 11, 2023
$ / shares
|
Measurement Input, Price Volatility [Member] | Minimum [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
48.36
|
|
|
Measurement Input, Price Volatility [Member] | Minimum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
67.19
|
|
|
Measurement Input, Price Volatility [Member] | Maximum [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
54.75
|
|
|
Measurement Input, Price Volatility [Member] | Maximum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
72.53
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
4.94
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
4.40
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
5.49
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
5.47
|
|
|
Measurement Input Volume Weighted Average Price [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
3.28
|
|
|
Measurement Input Volume Weighted Average Price [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
|
3.28
|
[1],[2] |
12.64
|
Measurement Input, Exercise Price [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
18.80
|
|
|
Measurement Input, Default Rate [Member] | Minimum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
5
|
|
|
Measurement Input, Default Rate [Member] | Maximum [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
25
|
|
|
Illiquidity Discount [Member] | Equity Option [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1] |
16
|
|
|
Illiquidity Discount [Member] | Warrant [Member] |
|
|
|
|
Debt Instrument, Measurement Input |
[1],[2] |
16
|
|
|
Measurement Input, Expected Term [Member] | Minimum [Member] | Equity Option [Member] |
|
|
|
|
Time period (years) |
[1] |
0 years
|
|
|
Measurement Input, Expected Term [Member] | Minimum [Member] | Warrant [Member] |
|
|
|
|
Time period (years) |
[1],[2] |
2 months 1 day
|
|
|
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|
|
|
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Time period (years) |
[1] |
11 months 12 days
|
|
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|
|
|
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Time period (years) |
[1],[2] |
2 years 9 months 14 days
|
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Schedule of Derivative Liabilities (Details)
|
3 Months Ended |
Mar. 31, 2024
USD ($)
|
Accelerated Feature [Member] |
|
Platform Operator, Crypto Asset [Line Items] |
|
Beginning balance |
$ 3,852
|
Gain on change in fair value of the derivative |
(1,817)
|
Ending balance |
2,035
|
Fair Value, Inputs, Level 3 [Member] |
|
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|
Beginning balance |
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|
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|
Ending balance |
$ 214,615
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v3.24.2.u1
Derivative Liabilities (Details Narrative)
|
Mar. 31, 2024
USD ($)
$ / shares
|
Dec. 31, 2023
USD ($)
|
Jan. 31, 2023
USD ($)
$ / shares
shares
|
Jan. 11, 2023
USD ($)
$ / shares
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Number of shares warrant to purchase | shares |
|
|
|
127,260
|
|
Exercise price per share | $ / shares |
|
|
|
$ 18.80
|
|
Derivative liability non-current | $ |
$ 214,615
|
|
$ 414,512
|
$ 1,189,000
|
|
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$ 216,650
|
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$ 2,631,000
|
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3.28
|
[1],[2] |
|
|
12.64
|
Derivative discount percentage |
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|
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14.00%
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Shuttle Pharmaceuticals (NASDAQ:SHPH)
過去 株価チャート
から 12 2024 まで 12 2024
Shuttle Pharmaceuticals (NASDAQ:SHPH)
過去 株価チャート
から 12 2023 まで 12 2024