UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
file number: 001-41340
KLOTHO NEUROSCIENCES, INC. |
(Exact name of registrant as specified in its charter) |
Delaware | | 86-2727441 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
13576 Walnut Street, Suite A Omaha, NE 68144 |
(Address of principal executive offices) (Zip Code) |
(833) 931-6330 |
(Registrant’s telephone number, including area code) |
|
(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 | | KLTO | | The Nasdaq Stock Market LLC |
Warrants | | KLTOW | | The Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 19, 2024, there were 21,263,515 shares of the registrant’s
common stock, $0.0001 par value, issued and outstanding.
KLOTHO
NEUROSCIENCES, INC.
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED SEPTEMBER
30, 2024
TABLE
OF CONTENTS
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
KLOTHO
NEUROSCIENCES, INC.
UNAUDITED CONSOLIDATED
BALANCE SHEETS
| |
September 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash | |
$ | 50,895 | | |
$ | 2,808 | |
Prepaid expenses | |
| 103,750 | | |
| 3,840 | |
Total current assets | |
| 154,645 | | |
| 6,648 | |
Intangible assets: | |
| | | |
| | |
Licenses | |
| 2,261,134 | | |
| 2,137,638 | |
Patents | |
| 48,420 | | |
| 48,420 | |
Total assets | |
$ | 2,464,199 | | |
$ | 2,192,706 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 271,129 | | |
$ | 151,259 | |
Accrued expenses | |
| 560,299 | | |
| 2,460 | |
Notes payable to related parties | |
| 151,000 | | |
| 159,000 | |
Notes payable | |
| - | | |
| 1,308,270 | |
Total current liabilities | |
| 982,428 | | |
| 1,620,989 | |
Warrant liability | |
| 21,200 | | |
| - | |
Total liabilities | |
| 1,003,628 | | |
| 1,620,989 | |
| |
| | | |
| | |
Commitments and contingencies (Note 10) | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred stock, par value $0.0001, 100,000,000 shares authorized; 0 issued and outstanding. | |
| - | | |
| - | |
Common stock, par value $0.0001, 1,000,000,000 shares authorized; 19,863,515 and 15,130,393 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. | |
| 1,986 | | |
| 1,513 | |
Additional paid-in capital | |
| 9,649,659 | | |
| 4,493,881 | |
Common stock to be issued | |
| 304,462 | | |
| - | |
Accumulated deficit | |
| (8,495,536 | ) | |
| (3,923,677 | ) |
Total stockholders’ equity | |
| 1,460,571 | | |
| 571,717 | |
Total liabilities and stockholders’ equity | |
$ | 2,464,199 | | |
$ | 2,192,706 | |
See
accompanying notes to the unaudited consolidated financial statements.
KLOTHO
NEUROSCIENCES, INC.
UNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS
| |
For
the Three Months Ended
September 30, | | |
For
the Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | |
| | |
| | |
| |
Professional fees | |
$ | 865,928 | | |
$ | 117,770 | | |
$ | 1,634,790 | | |
$ | 494,075 | |
General and administrative | |
| 2,005,004 | | |
| 5,967 | | |
| 2,053,794 | | |
| 26,514 | |
Total operating expenses | |
| 2,870,932 | | |
| 123,737 | | |
| 3,688,584 | | |
| 520,589 | |
| |
| | | |
| | | |
| | | |
| | |
Net operating loss | |
| (2,870,932 | ) | |
| (123,737 | ) | |
| (3,688,584 | ) | |
| (520,589 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (44,956 | ) | |
| (20,379 | ) | |
| (60,020 | ) | |
| (60,472 | ) |
Change in fair value of warrant liability | |
| 41,022 | | |
| - | | |
| 1,325 | | |
| - | |
Other income (expense) | |
| (84,560 | ) | |
| 5 | | |
| (335,830 | ) | |
| 78 | |
Total other income (expense) | |
| (88,494 | ) | |
| (20,374 | ) | |
| (394,525 | ) | |
| (60,394 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss before income taxes | |
| (2,959,426 | ) | |
| (144,111 | ) | |
| (4,083,109 | ) | |
| (580,983 | ) |
Income taxes | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (2,959,426 | ) | |
$ | (144,111 | ) | |
$ | (4,083,109 | ) | |
$ | (580,983 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share: Basic and Diluted | |
$ | (0.18 | ) | |
$ | (0.01 | ) | |
$ | (0.25 | ) | |
$ | (0.04 | ) |
Weighted average common shares outstanding – basic and diluted | |
| 16,688,945 | | |
| 15,130,393 | | |
| 16,588,940 | | |
| 15,130,393 | |
See
accompanying notes to the unaudited consolidated financial statements.
KLOTHO
NEUROSCIENCES, INC.
UNAUDITED CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
Total | |
| |
| | |
| | |
Preferred Stock | | |
Additional | | |
Common | | |
| | |
Stockholder’s | |
| |
Common Stock | | |
(Series B, C and D) | | |
Paid-in | | |
Stock | | |
Accumulated | | |
Equity | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
to be Issued | | |
Deficit | | |
(Deficit) | |
Balance, January 1, 2024, Revised | |
| 15,130,393 | | |
$ | 1,513 | | |
| 120,000 | | |
$ | 12 | | |
$ | 4,493,881 | | |
$ | - | | |
$ | (3,923,677 | ) | |
$ | 571,729 | |
Retroactive application of merger | |
| 548,505 | | |
| 55 | | |
| (120,000 | ) | |
| (12 | ) | |
| (1,318,672 | ) | |
| 304,200 | | |
| - | | |
| (1,014,429 | ) |
Adjusted balance, beginning of period* | |
| 15,678,898 | | |
| 1,568 | | |
| - | | |
| - | | |
| 3,175,209 | | |
| 304,200 | | |
| (3,923,677 | ) | |
| (442,700 | ) |
Public warrants assumed from SPAC | |
| - | | |
| - | | |
| - | | |
| - | | |
| 488,750 | | |
| - | | |
| (488,750 | ) | |
| - | |
Private warrants assumed from SPAC | |
| - | | |
| - | | |
| - | | |
| - | | |
| (22,525 | ) | |
| - | | |
| - | | |
| (22,525 | ) |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 37,252 | | |
| 262 | | |
| - | | |
| 37,514 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,123,683 | ) | |
| (1,123,683 | ) |
Balance June 30, 2024 | |
| 15,678,898 | | |
$ | 1,568 | | |
| - | | |
$ | - | | |
$ | 3,678,686 | | |
$ | 304,462 | | |
$ | (5,536,110 | ) | |
$ | (1,551,394 | ) |
Conversion of Notes Payable | |
| 3,750,617 | | |
| 375 | | |
| - | | |
| - | | |
| 4,009,634 | | |
| - | | |
| - | | |
| 4,010,009 | |
Warrant conversion | |
| 130,000 | | |
| 13 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 13 | |
Share-based compensation | |
| 304,000 | | |
| 30 | | |
| - | | |
| - | | |
| 1,952,821 | | |
| - | | |
| - | | |
| 1,952,851 | |
Other | |
| - | | |
| - | | |
| - | | |
| - | | |
| 8,518 | | |
| - | | |
| - | | |
| 8,518 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,959,426 | ) | |
| (2,959,426 | ) |
Balance at September 30, 2024 (unaudited) | |
| 19,863,515 | | |
$ | 1,986 | | |
| - | | |
$ | - | | |
$ | 9,649,659 | | |
$ | 304,462 | | |
$ | (8,495,536 | ) | |
$ | 1,460,571 | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Total | |
| |
| | |
| | |
Preferred
Stock | | |
Additional | | |
Additional | | |
| | |
Stockholder’s | |
| |
Common
Stock | | |
(Series
B, C and D) | | |
Paid-in | | |
Paid-in | | |
Accumulated | | |
Equity | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Capital | | |
Deficit | | |
(Deficit) | |
Balance,
January 1, 2023 as recast | |
| - | | |
$ | - | | |
| 1,405,250 | | |
$ | 475 | | |
$ | 3,419,003 | | |
$ | - | | |
$ | (3,216,219 | ) | |
$ | 203,259 | |
Retroactive
application of merger | |
| 15,130,393 | | |
| 1,513 | | |
| (1,405,250 | ) | |
| (475 | ) | |
| 1,074,878 | | |
| - | | |
| - | | |
| 1,075,916 | |
Adjusted
balance, beginning of period at 6/21/2024 | |
| 15,130,393 | | |
| 1,513 | | |
| - | | |
| - | | |
| 4,493,881 | | |
| - | | |
| (3,216,219 | ) | |
| 1,279,175 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (580,983 | ) | |
| (580,983 | ) |
Balance
at September 30, 2023, Revised | |
| 15,130,393 | | |
$ | 1,513 | | |
| - | | |
$ | - | | |
$ | 4,493,881 | | |
$ | - | | |
$ | (3,797,202 | ) | |
$ | 698,192 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (126,475 | ) | |
| (126,475 | ) |
Balance
at December 31, 2023 (unaudited) | |
| 15,130,393 | | |
$ | 1,513 | | |
| - | | |
$ | - | | |
$ | 4,493,881 | | |
$ | - | | |
$ | (3,923,677 | ) | |
$ | 571,717 | |
See
accompanying notes to the unaudited consolidated financial statements.
KLOTHO
NEUROSCIENCES, INC.
UNAUDITED CONSOLIDATED
STATEMENTS OF CASH FLOWS
| |
For the Nine Months Ended
| |
| |
September 30,
2024 | | |
September 30,
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss | |
$ | (4,083,109 | ) | |
$ | (580,983 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Changes in fair value of warrant liability | |
| (1,325 | ) | |
| - | |
Commitment fee | |
| 250,000 | | |
| - | |
Stock-based compensation | |
| 1,990,366 | | |
| 100,000 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses | |
| (99,910 | ) | |
| (1,613 | ) |
Accounts payable | |
| 19,870 | | |
| 168,966 | |
Accrued expenses | |
| 557,839 | | |
| 21,224 | |
Tax payable | |
| (568,111 | ) | |
| - | |
Related party payable | |
| (128,000 | ) | |
| 45,000 | |
Other liabilities | |
| 60,022 | | |
| - | |
Net cash used in operating activities | |
$ | (2,002,358 | ) | |
$ | (247,406 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
| |
| | | |
| | |
Acquisition of patents | |
| - | | |
| (10,000 | ) |
Acquisition of licenses | |
| (123,497 | ) | |
| (66,325 | ) |
Net cash used in investing activities | |
$ | (123,497 | ) | |
$ | (76,325 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from convertible promissory note | |
| 1,000,000 | | |
| - | |
Proceeds from sales of stocks and warrants, net | |
| 175,000 | | |
| - | |
Proceeds from related party loans | |
| 100,000 | | |
| - | |
Proceeds from shareholders | |
| 120,000 | | |
| - | |
Merger proceeds net of transaction cost | |
| 778,942 | | |
| - | |
Repayment of advance to shareholder | |
| - | | |
| 250,000 | |
Net cash provided by financing activities | |
$ | 2,173,942 | | |
$ | 250,000 | |
| |
| | | |
| | |
NET CHANGE IN CASH | |
| 48,087 | | |
| (73,731 | ) |
Cash - Beginning of period | |
| 2,808 | | |
| 75,872 | |
Cash - End of period | |
$ | 50,895 | | |
$ | 2,141 | |
| |
| | | |
| | |
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES: | |
| | | |
| | |
Note payable settled with issuance of common stock | |
$ | 5,258,270 | | |
$ | - | |
Interest payable settled with issuance of common stock | |
$ | 60,022 | | |
$ | - | |
Non-cash directors and officers insurance | |
$ | 154,500 | | |
$ | - | |
Non-cash PIPE Funds used for merger transaction close | |
$ | 2,950,000 | | |
$ | - | |
Commitment fee paid in stock | |
$ | 250,000 | | |
$ | - | |
Assumed warrant liability from merger | |
$ | 22,525 | | |
$ | - | |
Assumed income tax payable | |
$ | 568,111 | | |
$ | - | |
Warrant conversion | |
$ | 96,200 | | |
$ | - | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW INFORMATION: | |
| | | |
| | |
Interest Paid | |
$ | 2,460 | | |
$ | 37,707 | |
Taxes Paid | |
$ | - | | |
$ | - | |
See
accompanying notes to the unaudited consolidated financial statements.
KLOTHO
NEUROSCIENCES, INC.
NOTES
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — ORGANIZATION
AND BUSINESS DESCRIPTION
Klotho
Neurosciences, Inc. (“The Company” or “Klotho”), formerly known as ANEW Medical, Inc., develops essential medicines
for the treatment of chronic diseases – cancer, cardiovascular, and neurodegenerative disorders. The Company currently has acquired
two licensed platforms: a generic drug portfolio and a biosimilar biologics platform that uses biologic therapies to treat cancer, and
two proprietary, patented technologies involving the melanocortin receptor-binding molecules and a gene therapy platform which uses a
gene therapy approach to introduce a therapeutic protein called “Klotho” inside the body to treat neurodegenerative diseases.
On
September 12, 2022, the Company acquired five market-approved anti-cancer drugs approved for sale in Germany. The Market Authorizations
(MA’s) are for four of the drugs that comprise the “FOLFOX” and “FOLFIRI” multi-drug regimens used in treatment
of metastatic colorectal and gastric cancer and in two of the drugs that are used to treat metastatic lung cancer. The drugs are important
in the treatment of many solid tumors in both childhood and adult cancers. Previously, the Company acquired two off-patent bio generic
antibodies from Reliance Life Sciences (RLS), the life science arm of Reliance Industries Pvt Ltd. of Navi Mumbai, India.
During
January 2023, the Company acquired a treatment for small drug molecules that bind to the melanocortin receptors on human cells and affect
skin pigmentation.
Effective July 24, 2024, the Company changed its legal name from ANEW
Medical, Inc. to Klotho Neurosciences, Inc. This name change was approved by the Company’s Board of Directors to better reflect
the strategic focus of its proprietary products. Throughout these financial statements, references to the “Company” refer
to Klotho Neurosciences, Inc., formerly known as ANEW. Under certain circumstances, references to ANEW have remained when useful in describing
the sequence of events that occurred during the merger between Redwoods and ANEW.
Business
Combinations
As of May 30, 2023, Redwoods Acquisition Corp., a Delaware corporation
and a special purpose acquisition company (“Redwoods”), Anew Medical Sub, Inc., a Wyoming corporation (“Merger Sub”)
and ANEW Medical, Inc., a Wyoming corporation (“ANEW”) entered into a Business Combination Agreement, which was amended as
of November 4, 2023 (the “Business Combination Agreement”). On June 21, 2024 (the “Closing Date”), Merger Sub
merged with and into ANEW, with ANEW continuing as the surviving corporation and as a wholly owned subsidiary of Redwoods (the “Business
Combination”). In connection with the Business Combination, on June 21, 2024, Redwoods filed its Second Amended Certificate of Incorporation
with the Delaware Secretary of State, and adopted the amended and restated bylaws (the “Amended and Restated Bylaws”), which
replaced Redwoods’ Charter and Bylaws in effect as of such time. In connection with the closing of the Business Combination (the
“Closing”), Redwoods changed its name to “ANEW Medical, Inc.”
For accounting purposes, the transactions contemplated by the Business
Combination are treated as a reverse acquisition and, as such, the historical financial statements of the accounting acquirer ANEW (Wyoming)
will become the historical financial statements of the Company. Under this method of accounting, Redwoods was treated as the
acquired company for financial reporting purposes. Accordingly, for accounting purposes, the Merger was treated as the equivalent of the
Company issuing shares for the net assets of Redwoods, accompanied by a recapitalization. The net assets of Redwoods
were stated at historical cost with no goodwill or other intangible assets recorded.
Recapitalization
In connection with the merger, the Company issued six million
shares in exchange for all of the outstanding shares of ANEW. At $10 per Redwood’s share, the valuation of ANEW was $60 million.
Immediately after giving effect to the Business Combination, 15,130,393
shares of Company Common Stock were outstanding, from which 2,875,000 remain in escrow for the Redwoods founders. In addition, there were
12,030,000 warrants immediately exercisable and composed of 11,500,000 public warrants and 530,000 private warrants. Following the Closing,
on June 21, 2024, the Company’s Common Stock and Warrants began trading on the Nasdaq under the symbols “WENA” and “WENAW,”
respectively. The Public Units of Redwoods automatically separated into the component securities upon consummation of the Business Combination
and, as a result, no longer trade as a separate security. Further, upon closing of the Business Combination on June 21, 2024, the Company
received approximately $181,339 in net cash proceeds. During the three months ended September 30, 2024, the Company determined there was
an additional approximate $8,500 cash.
At Closing,
pursuant to the terms of the Business Combination Agreement and after giving effect to the redemptions of shares of Redwoods Common Stock:
| ● | The total consideration paid at Closing (the “Merger
Consideration”) by Redwoods to ANEW Medical, Inc. security holders was 6,000,000 shares of the Company common stock valued at $60
million (the “Consideration Shares”), based on an implied ANEW equity value of $60,000,000 valued at $10 per share; |
| ● | Each share of ANEW Medical Common Stock, if any, that was
owned by Redwoods, Merger Sub, ANEW Medical, Inc. or any other affiliate of Redwoods immediately prior to the effective time of the Merger
(the “Effective Time”) was automatically cancelled and retired without any conversion or consideration; |
| ● | Each share of Merger Sub common stock, par value $0.0001
per share (“Merger Sub Common Stock”), issued and outstanding immediately prior to the Effective Time was converted into
one newly issued share of Common Stock of the Surviving Corporation. |
In connection with the Merger,
the Company entered into a convertible promissory note and Securities Purchase Agreement (“SPA”) with certain accredited investors
(the “Redwoods PIPE Investors”) for an aggregate of 750,000 shares (bonus free trading shares and restricted
shares issued at closing), with each unit consisting of one share of Company common stock (the “PIPE Shares”)
for an aggregate purchase price of $2,000,000 (the “Redwoods PIPE Financing”). Upon the closing of the
Redwoods PIPE Financing (which closed in connection with the closing of the Merger), the $2,000,000 were used by the Company
to settle transaction costs. The Company received approximately $181,339 in net cash proceeds and recorded a receivable of $50,000 from
the Redwoods PIPE Financing funds.
In connection with the Merger,
the Company entered convertible promissory note and Securities Purchase Agreement (“SPA”) with certain accredited investors
(the “ANEW PIPE Investors”) for an aggregate of 854,257 units (bonus free trading shares and restricted shares
issued at closing), with each unit consisting of one share of Company common stock (the “PIPE Shares”)
for an aggregate purchase price of $2,000,000 (the “ANEW PIPE Financing”). Upon the closing of the
ANEW PIPE Financing (which closed in connection with the closing of the Merger), $1,000,000 was used by the Company to
settle transaction costs. The Company received approximately $950,000 in cash proceeds and recorded a receivable of $50,000 from the ANEW
PIPE Financing funds.
Concurrent with Closing,
certain ANEW stockholders may be entitled to up to an additional 5,000,000 shares of Company Common Stock (the “Contingent Consideration
Shares”), upon the following conditions being met:
| (i) | 2,000,000 Contingent Consideration Shares upon the Company’s common stock achieving a closing price equal to or exceeding $12.50 for 10 trading days within a 20-day trading period in the first three years following the Closing; |
|
(ii) |
2,000,000 Contingent Consideration Shares upon the Company’s common stock achieving a closing price equal to or exceeding $15.00 for 10 trading days within a 20-day trading period in the first three years following the Closing; and |
|
(iii) |
1,000,000 Contingent Consideration Shares upon the Company’s common stock achieving a closing price equal to or exceeding $20.00 for 10 trading days within a 20-day trading period in the first five years following the Closing. |
In
accordance with guidance applicable to these circumstances, the equity structure has been restated in all comparable periods up to June
21, 2024 and reflected as such as of September 30, 2024, to reflect the number of shares of the Company’s common stock, $0.0001 par
value per share, issued to ANEW’s stockholders in connection with the merger. As such, the shares and corresponding capital amounts
and earnings per share related to ANEW’s common stock prior to the merger have been retroactively restated as shares reflecting
the exchange ratio established in the merger.
For accounting purposes, the Merger was treated as the equivalent of the
Company issuing shares for the net assets of Redwoods, accompanied by a recapitalization. The net assets of Redwoods
were stated at historical cost with no goodwill or other intangible assets recorded. In connection with the Merger, in addition to
the warrants, ANEW Medical assumed $589,081 in cash and $568,111 in income tax payable. The income tax payable of $568,111 was
settled in full as of September 30, 2024 from the assumed $589,081 cash.
NOTE 2 — SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Going Concern
The accompanying unaudited consolidated financial
statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses
and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash of approximately $51,000 and an
accumulated deficit of approximately $8.5 million. The Company has incurred recurring losses, has experienced recurring negative
operating cash flows, and requires significant cash resources to execute its business plans. The Company is dependent on obtaining additional
working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue
operations. Without additional funding, there is substantial doubt about the Company’s ability to continue as a going concern for
twelve months from the date of these financial statements.
Basis
of Presentation and Principles of Consolidation
The
Company prepares its consolidated financial statements in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC. The Company prepared the Financial Statements,
without audit, pursuant to the rules and regulations of the SEC applicable to quarterly reporting on Form 10-Q and reflect, in management’s
opinion, all adjustments necessary to present fairly the financial information. All such adjustments are of a normal recurring nature.
Certain information and footnote disclosures normally included in financial statements, prepared in accordance with generally accepted
accounting principles, have been consolidated or omitted as permitted by such rules and regulations. These Financial Statements should
be read in conjunction with the consolidated financial statements and related notes included in the 2023 Annual Report. Results of operations
for interim periods are not necessarily indicative of annual results.
Reclassification
Certain
prior year amounts have been reclassified for comparative purposes to conform to the current-year financial statement presentation. These
reclassifications had no effect on previously reported results of operations and were not material.
Emerging
Growth Company
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities
Act”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of
certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies
including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions
from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute
payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to
comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act
registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards. The JOBS
Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging
growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition
period which means that when a standard is issued or revised and it has different application dates for public or private companies,
the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised
standard. This may make comparison of the Company’s financial statements with another public company which is neither an emerging
growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because
of the potential differences in accounting standards used.
Use
of Estimates
The
preparation of unaudited consolidated financial statements in conformity with U.S. GAAP requires the Company’s 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 financial statements and the reported amounts of revenues and expenses during the reporting period.
Making
estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of
a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating
its estimate, could change in the near term due to one or more future confirming events. Accordingly, the actual results could differ
significantly from those estimates.
Cash
and Cash Equivalents
Cash
and cash equivalents represent cash on hand, demand deposits, and other short-term highly liquid investments placed with banks,
which have original maturities of three months or less and are readily convertible to known amounts of cash.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution,
which, at times, may exceed the Federal Depository Insurance Coverage of $250,000. As of September 30, 2024, the Company has not experienced
losses on this account and management believes the Company is not exposed to significant risks on such account.
Fair
Value of Financial Instruments
The
assets and liabilities are valued using a fair market basis as defined in the Financial Accounting Standards Board (“FASB”)
Accounting Standards Update (“ASU”) ASC 820, Fair Value Measurement. Fair value is the price the Company would receive
to sell an asset or pay to transfer a liability in an orderly transaction with a market participant at the measurement date. The Company
uses a three-level hierarchy established by the FASB that prioritizes fair value measurements based on the types of inputs used
for the various valuation techniques (market approach, income approach and cost approach). The levels of the fair value hierarchy are
described below:
|
Level 1: |
Quoted
prices in active markets for identical assets or liabilities. |
|
|
|
|
Level 2: |
Inputs
other than quoted prices that are observable for the asset or liability, either directly or indirectly; these include quoted prices
for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that
are not active. |
|
|
|
|
Level 3: |
Unobservable
inputs with little or no market data available, which require the reporting entity to develop its own assumptions. |
The
Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment
and considers factors specific to the asset or liability. Financial assets and liabilities are classified in their entirety based on
the most conservative level of input that is significant to the fair value measurement.
| |
Fair value measurements at reporting date using: | |
| |
Fair value | | |
Quoted prices in active markets for identical liabilities (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
Liabilities: | |
| | |
| | |
| | |
| |
Representative warrant liabilities, September 30, 2024 | |
$ | 21,200 | | |
$ | - | | |
$ | - | | |
$ | 21,200 | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Representative warrant liabilities, December 31, 2023 | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
The
following tables present a reconciliation of the Level 3 Private Warrants liabilities:
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Representative warrant liabilities, January 1 | |
$ | - | | |
$ | - | |
Issuances/Assumptions | |
| 22,525 | | |
| - | |
Change in fair value | |
| (1,325 | ) | |
| - | |
Representative warrant liabilities, September 30 | |
$ | 21,200 | | |
$ | - | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Representative warrant liabilities, July 1 | |
$ | 62,222 | | |
$ | - | |
Change in fair value | |
| (41,022 | ) | |
| - | |
Representative warrant liabilities, September 30 | |
$ | 21,200 | | |
$ | - | |
Intangible
Assets
The
Company’s intangible assets consist of acquired medical licenses and patents.
The Company acquires medical licenses for the treatment of medical
conditions to market and sell in the future. The initial asset cost is the cost to acquire the license. Once in use, the Company amortizes
the license cost over the useful life using the straight-line method. As part of the licensing agreements, the Company acquires patents
and records the cost to acquire patents as the initial asset cost. Once the patents are approved and in use, assuming no litigations expenses,
the Company amortizes the patent cost over the useful life using the straight-line method. The amortization period will not exceed the
lifespan of the protection afforded by the patent. If the expected useful life of the patent is even shorter, the Company will use the
useful life for amortization purposes. Thus, the shorter of a patent’s useful life or legal life will be used for the amortization
period.
Impairment
of Long-Lived and Intangible Assets
The Company assesses the impairment of long-lived and intangible assets
periodically, or at least annually, and whenever events or changes in circumstances indicate that the carrying value may not be recoverable.
Factors considered important, which could trigger an impairment review, include the following: significant underperformance relative to
historical or projected future cash flows; significant changes in the manner of use of the assets or the strategy of the overall business;
and significant negative industry trends. When management determines that the carrying value of long-lived and intangible assets may not
be recoverable, impairment is measured as the excess of the assets’ carrying value over the estimated fair value. Management is
not aware of any other impairment charges that may currently be required; however, the Company cannot predict the occurrence of events
that might adversely affect the reported values in the future. On an annual basis, the Company tests the long-lived and intangible assets
for impairment based on the projected net present value of cash flows for each asset. Prior to the annual impairment test, if circumstances
change and a long-lived or intangible asset is deemed impaired, an impairment loss will be immediately recognized in the statements of
operations. At December 31, 2023, the date of the last impairment test, it was determined that the estimated fair value of the intangible
assets exceeded the carrying value of the assets by 50%, indicating no impairment.
Revenue
Recognition
The
Company is in a pre-revenue state and does not generate revenue. When the Company commences to derive revenue, those contracts will be
accounted in accordance with ASU 2014-09, Revenue from Contracts with Customers (Topic ASC 606).
Income
Taxes
The
Company uses the asset and liability method of accounting for income taxes in accordance with ASU 740, “Income Taxes”. Under
this method, income tax expense is recognized as the amount of: (i) taxes payable or refundable for the current year and (ii) future
tax consequences attributable to differences between the consolidated financial statements carrying amounts of existing assets and
liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply
to taxable income in the years which those temporary differences are expected to be recovered or settled. The effect on deferred
tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment
date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of available evidence it is
more likely than not that some portion or all of the deferred tax assets will not be realized.
The
Company is subject to Income tax filings requirements in U.S. federal and various state jurisdictions. The Company’s tax returns
for years from 2021, 2022, and 2023 are subject to U.S. federal, state, and local income tax examinations by tax authorities.
The
Company reports income tax related interest and penalties within the income tax line item on the consolidated statements of operations.
The Company likewise reports the reversal of income tax-related interest and penalties within such line item to the extent the Company
resolves the liabilities for uncertain tax positions in a manner favorable to the accruals.
Net
Loss Per Share (Basic and Diluted)
Basic
net loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net
loss per share is computed by dividing net loss by the weighted average number of shares outstanding, plus the number of additional shares
that would have been outstanding if the common share equivalents had been issued, if dilutive.
The
following table details the net loss per share calculation, reconciles between basic and diluted weighted average shares outstanding,
and presents the potentially dilutive shares that are excluded from the calculation of the weighted average diluted common shares outstanding,
because their inclusion would have been anti-dilutive:
| |
For the Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
Numerator: | |
| | |
| |
| |
| | |
| |
Net loss | |
$ | (4,083,109 | ) | |
$ | (580,983 | ) |
| |
| | | |
| | |
Weighted average shares outstanding (denominator for basic earnings per share) | |
| 16,588,940 | | |
| 15,130,393 | |
| |
| | | |
| | |
Weighted average shares and assumed potential common shares (denominator for diluted earnings per share, treasury method) | |
| 16,588,940 | | |
| 15,130,393 | |
| |
| | | |
| | |
Basic loss per share | |
$ | (0.25 | ) | |
$ | (0.04 | ) |
Diluted loss per share | |
$ | (0.25 | ) | |
$ | (0.04 | ) |
The
following common share equivalents are excluded from the calculation of weighted average common shares outstanding, because their inclusion
would have been anti-dilutive:
| |
For the Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 12,030,000 | | |
| 12,030,000 | |
Total potentially dilutive shares | |
| 12,030,000 | | |
| 12,030,000 | |
Research
and Development Cost
Research
and development (R&D) costs are expensed as incurred. R&D costs are related to the Company’s internally funded development
of the Company medical licenses and patents. The Company R&D costs were $0 for the three and nine months ended September
30, 2024 and 2023, respectively.
Share-based
Compensation
The
Company accounts for share-based compensation in accordance with the fair value recognition provisions of the Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) No. 718 and No. 505. The Company issues restricted stock
to employees and consultants for their services. Cost for these transactions are measured at the fair value of the equity instruments
issued at the date of grant. These shares are considered fully vested and the fair market value is recognized as an expense in the period
granted. The Company recognized consulting expenses and a corresponding increase to additional paid-in-capital related to stock issued
for services. For agreements requiring future services, the consulting expense is to be recognized ratably over the requisite service
period.
The
Company recorded share-based compensation of $1,990,366 and $100,000 for the nine months ended September 30, 2024, and 2023, respectively.
Warrants
As
of September 30, 2024, the fair value of the Representative Warrant liabilities was $21,200 based on the closing price of the warrants
on The Nasdaq Capital Market. The fair value of the Representative Warrants was approximately $0.04 per Representative Warrant, which
was based on the relative fair value to the Public Warrants. During the quarter, our Public and Private Warrants met the conditions necessary
to adjust the exercise price and the redemption trigger price. As of September 30, 2024, the exercise price was $3.49 per warrant, and
the redemption trigger price was $5.01. During the three months ended September 30, 2024, the fair value of the Representative warrants
decreased by $41,022.
During the three months
ended September 30, 2024, a warrant holder exercised 130,000 warrants issued as part of the Series D Preferred Shares related to the Business
Combination, with a total value of $96,200, valued as of September 27, 2024.
Related
Parties
The
Company follows subtopic 850-10 of the FASB Accounting Standards Codification for the identification of related parties and disclosure
of related party transactions.
Pursuant
to Section 850-10-20 the related parties include (a) affiliates of the Company; (b) entities for which investments in their equity securities
would be required, absent the election of the fair value option under the Fair Value Option Subsection of Section 825–10–15,
to be accounted for by the equity method by the investing entity; (c) trusts for the benefit of employees, such as pension and profit-sharing
trusts that are managed by or under the trusteeship of management; (d) principal owners of the Company; (e) management of the Company;
(f) other parties with which the Company may deal if one party controls or can significantly influence the management or operating policies
of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests; and
(g) other parties that can significantly influence the management or operating policies of the transacting parties or that have an ownership
interest in one of the transacting parties and can significantly influence the other to an extent that one or more of the transacting
parties might be prevented from fully pursuing its own separate interests.
The
financial statements shall include disclosures of material related party transactions, other than compensation arrangements, expense
allowances, and other similar items in the ordinary course of business. However, disclosure of transactions that are eliminated in the
preparation of consolidated or combined financial statements is not required in those statements. The disclosures shall include: (a)
the nature of the relationship(s) involved; (b) description of the transactions, including transactions to which no amounts or nominal
amounts were ascribed, for each of the periods for which income statements are presented, and such other information deemed necessary
to an understanding of the effects of the transactions on the financial statements; (c) the dollar amounts of transactions for each of
the periods for which income statements are presented and the effects of any change in the method of establishing the terms from that
used in the preceding period; and (d) amounts due from or to related parties as of the date of each balance sheet presented and, if not
otherwise apparent, the terms and manner of settlement.
Recent
Accounting Pronouncements
Management
does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material
effect on the Company’s consolidated financial statements.
NOTE 3 — PREPAID
EXPENSES
Prepaid expenses consist of prepayment of the premium on Directors
and Officers insurance. As of September 30, 2024 and December 31, 2023, prepaid expenses totaled $103,750 and $3,840, respectively, in
the accompanying consolidated balance sheets.
NOTE 4 — INTANGIBLE
ASSETS
Intangible
assets consisted of the following:
Intangible Assets | |
September 30, 2024 | | |
December 31, 2023 | |
Licenses | |
| | |
| |
Non-Exclusive License Agreement | |
$ | 179,821 | | |
$ | 56,325 | |
Proprietary pharmaceutical drugs | |
| 10,000 | | |
| 10,000 | |
Various generic drugs | |
| 736,983 | | |
| 736,983 | |
Four generic drugs (Encore) | |
| 1,308,270 | | |
| 1,308,270 | |
Needleless Syringe License | |
| 26,060 | | |
| 26,060 | |
Patents | |
| 48,420 | | |
| 48,420 | |
Total intangible assets | |
$ | 2,309,554 | | |
$ | 2,186,058 | |
Intangible assets are
as follows:
| ● | Non-Exclusive
License Agreement ($179,821) – On March 5, 2023, the Company signed a Non-Exclusive License Agreement with Heidelberg University
to grant non-exclusive rights to various licenses owned and under development by the university. The licenses include the use of modified
AAV capsid polypeptides for treatment of muscular diseases. The terms include a €50,000 ($56,325) fee for signing the agreement
and €100,000 ($112,650) payment within 60 days of the anniversary of signing the agreement. The Company will pay €1,000,000
($1,126,500) for each assignment of a right to a license owned by the university. For new licenses, the Company will make standard commercial
development-based milestone payments for the various stages of license development and regulatory approval. The Company will make 2 %
royalty payments by January 31st each year during the term of the agreement for each licensed product for the proceeding
calendar year. At September 30, 2024, the Company paid $179,821 under the agreement. |
| ● | Proprietary Pharmaceutical Drugs ($10,000) – On January 27, 2023, the Company signed a License Agreement with Teleost Biopharmaceutic, LLC to acquire various assets for the Company’s proprietary pharmaceutical program segment. The license includes the use of patented small drug molecules that bind to the melanocortin receptors on human cells and affect skin pigmentation. The terms include a $10,000 fee for signing the agreement and a $50,000 payment on January 27, 2024. The Company will pay for all new patent costs for new discoveries and new treatments. The Company will make standard commercial development-based milestone payments for the various stages of license development and regulatory approval. In addition, the Company will make royalty payments on the net sales for commercial products. Beginning in 2025, the Company will also pay patent and license maintenance fees. The amount due under the agreement was $10,000 at September 30, 2024. The License Agreement with Teleost Biopharmaceutic, LLC was terminated as of November 8, 2024. See note 11- subsequent events for additional detail. |
| ● | Various
Generic Drugs ($736,983) - During 2015, the Company acquired two licenses for two licensed platform technologies, a biosimilar
biologics platform that uses biologic therapies to treat cancer – recombinant antibodies, and a gene therapy platform which uses
a gene therapy approach to introduce a therapeutic protein called “Klotho” inside the body to treat neurodegenerative diseases.
The value of the licenses was $736,983 at September 30, 2024. |
| ● | Four
Generic Drugs (Encore) ($1,308,270) – On September 12, 2022, the Company acquired four market-approved anti-cancer
drugs approved for sale in Germany for $1,308,270. The purchase price represents the fair value of the intangible asset based on
the net present value of the projected gross profit to be generated by the licenses. The value of the licenses was $1,308,270 at September
30, 2024 and December 31, 2023. |
| ● | Needleless
Syringe License ($26,060) – On December 1, 2023, the Company signed a license agreement with TransferTech Sherbooke for
the rights to develop and commercialize the technology of a “Needleless Syringe.” Under the terms of the agreement, the Company
paid a $26,060 upfront fee and royalty fees on the license income. The Company has not commenced developing the technology. The amount
paid was $26,060 at September 30, 2024. |
| ● | Patents
($48,420) – Through its licensing arrangements, the Company acquires the right to patents for Alzheimer, ALS and other
items. Once the patents are declared effective, patents are amortized using the straight-line method over their estimated useful
lives or statutory lives, whichever is shorter, and will be reviewed for impairment upon any triggering event that may impact the assets’
ultimate recoverability as prescribed under the guidance related to impairment of long-lived assets. Costs incurred to acquire patents,
including legal costs, are also capitalized as long-lived assets and amortized on a straight-line basis with the associated patent. At
December 31, 2023, certain professional fees incurred for the patents in the amount of $47,740 were deemed not capitalizable and were
expensed as professional fees in the accompanying statements for operations. At September 30, 2024, professional fees incurred for the
patents in the amount of $30,898 were deemed not capitalizable and were expensed as professional fees in the accompanying statements
for operations. The patent value, which I spart of licenses in the accompanying consolidated balance sheet, as of September 30, 2024
and December 31, 2023 was $48,420, respectively. |
| ● | Exclusive
World-wide License Agreement - On January 24, 2022, the Company signed an exclusive, world-wide License Agreement with the University
of Barcelona for a cell and/or gene therapy that has shown compelling activity in animal models of human Alzheimer’s disease and
amyotrophic lateral sclerosis (“ALS” or “Lou Gehrig’s disease”). The gene therapy will also be applied
to age-related diseases and rare (“Orphan”) diseases. Beginning on December 15, 2022, the Quarterly license fee is 10,000
Euros. In addition, the Company will pay a Royalty equal to 3% of net sales of finished products. For the nine months ended September
30, 2024 and 2023, the Company owes $0 under the agreement. |
These
licenses and patents are not currently in use as the Company is pre-revenue stage. Once these licenses are in use, the licenses
will be amortized over its useful life. The Company expects to utilize these licenses and patents in year 2025.
NOTE
5 — ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of professional fees.
The accounts payable and accrued expenses as of September 30, 2024 and December 31, 2023 were $831,428 and $153,719, respectively, in
the accompanying consolidated balance sheet.
NOTE 6 – NOTES
PAYABLE TO RELATED PARTIES
Notes payable to related
parties consisted of the following:
| |
September 30,
2024 | | |
December 31,
2023 | |
| |
| | |
| |
December 2023 - $135,000 original amount bearing no interest due upon demand | |
$ | - | | |
$ | 135,000 | |
May 2024 and December 2023 - $7,000 and $24,000 original amount bearing a one-time interest fee of $2,460 due upon demand. | |
| 31,000 | | |
| 24,000 | |
August 2024 - $80,000 original amount bearing no interest due upon demand | |
| 80,000 | | |
| - | |
August 2024 - $20,000 original amount bearing no interest due upon demand | |
| 20,000 | | |
| - | |
September 2024
- $20,000 original amount bearing no interest due upon demand | |
| 20,000 | | |
| - | |
Total notes payable to related parties | |
$ | 151,000 | | |
$ | 159,000 | |
December
2023 ($135,000) – On December 1, 2023, the Company issued a promissory note to two members of management in the amount
of $135,000. The promissory note did not accrue interest. The unpaid principal balance was $0 and $135,000 at September 30, 2024 and
December 31, 2023, respectively.
May 2024 and December
2023 ($7,000 and $24,000) – On December 12, 2023, the Company issued a promissory note to a member of management. The promissory
note accrued interest at a one-time interest fee of $2,460, which was paid off as of September 30, 2024. The unpaid principal balance was
$31,000 and $24,000 at September 30, 2024 and December 31, 2023, respectively.
August 2024 ($80,000)
– On August 27, 2024, the Company issued a promissory note to a member of management. The promissory note accrues no interest.
The unpaid principal balance was $80,000 and $0 at September 30, 2024 and December 31, 2023, respectively.
August 2024 ($20,000)
– On August 27, 2024, the Company issued a promissory note to a member of management. The promissory note accrues no interest.
The unpaid principal balance was $20,000 and $0 at September 30, 2024 and December 31, 2023, respectively.
September 2024
($20,000) – On September 30, 2024, the Company issued a promissory note to a member of management. The promissory note
accrues no interest. The unpaid principal balance was $20,000 and $0 at September 30, 2024 and December 31, 2023, respectively.
NOTE 7 — NOTES
PAYABLE
On September 12, 2022, the Company issued a $1,308,270 promissory note
used to acquire four market-approved anti-cancer drugs. See Note 4 – Intangible Assets for further discussion.
The promissory note bore interest at 6% and had a maturity date of June 30, 2023. Pursuant to the agreement, the interest stopped accruing
at June 30, 2023. As of December 31, 2023, the Company made interest payments of $78,496 to fully satisfy the interest obligation under
the promissory note. The note was converted into the Company’s common shares and fully settled as part of the merger that closed
on June 21, 2024. The unpaid principal balance of the note was $0 and $1,308,270 at September 30, 2024 and December 31, 2023, respectively.
On
March 4, 2024, in connection with the Merger, Public ANEW entered into a convertible promissory note and Securities Purchase Agreement
(“SPA”) with certain accredited investors (the “Redwoods PIPE Investors”) for an aggregate purchase price
of up to $2,000,000 (the “Redwoods PIPE Financing”), which included 750,000 bonus shares of common stock. Upon the closing of the
Redwoods PIPE Financing (funded and closed in connection with the closing of the Merger on June 21, 2024), which totaled
$1,950,000, of which $1,768,661 was used by the Company to settle transaction costs. The Company received approximately $181,339 in net
cash proceeds.
On April 22, 2024, prior to the closing of the
Business Combination Agreement, ANEW Medical (Wyoming) entered into a convertible promissory note and Securities Purchase Agreement (“SPA”)
with certain accredited investors (the “ANEW PIPE Investors”) for an aggregate purchase price of up to $2,000,000 (the
“ANEW PIPE Financing”), which included 900,000 bonus shares of common stock. Upon the closing of the ANEW PIPE Financing
(funded and closed in connection with the closing of the Merger on June 21, 2024), which totaled $1,950,000 initially,
of which $1,000,000 was used by the Company to settle transaction costs. The Company received approximately $1,000,000 in cash proceeds
during the nine months ended September 30, 2024 and $50,000 during the three months ended September 30, 2024.
Both convertible promissory notes, Redwoods PIPE
Financing and ANEW PIPE Financing, bore an interest rate of 10%.
During the third quarter of 2024, investors converted convertible promissory
notes totaling $4,010,022, including $3,950,000 of principal and $60,022 accrued interest, through the issuance of 4,050,617 shares of
common stock, of which 3,750,617 shares of common stock were issued and outstanding as of September 30, 2024. On October 2, 2024, 300,000
shares of common stock were issued to satisfy the liability in full.
NOTE 8 — RELATED
PARTIES
On October 10, 2021,
the Company signed an Employment Agreement with Dr, Joseph Sinkule to serve as the Company’s CEO for three years ending on October
9th, 2024. In addition, Mr. Sinkule will serve as a member of the board of directors for a five-year term. Mr. Sinkule’s
annual salary will be $240,000 per year and increase to $360,000 per year upon raising a total of five million dollars ($5,000,000) or
more in equity and/or debt financing. The Company’s CEO has earned $240,000 for the years ended December 31, 2023 and 2022. In accordance
with the agreement, at September 30, 2024 and December 31, 2023, the Company’s CEO is owed $0 and $80,000, respectively.
During November 2022,
the Company advanced a shareholder $300,000 as a short-term loan. The loan is non-interest bearing and due by the end of December 2022.
The shareholder repaid $50,000 during December 2022 and $250,000 in January 2023 to fully satisfy the advance. At September 30, 2024 and
December 31, 2023, the loan balance was $0.
On December 12, 2023, the Company issued a promissory note to a member
of management. The promissory note accrued interest at a one-time interest fee of $2,460, which was paid off as of September 30, 2024.
The unpaid principal balance was $31,000 and $24,000 at September 30, 2024 and December 31, 2023, respectively.
On
August 27, 2024, the Company issued a promissory note to a member of management. The promissory note accrues no interest. The unpaid
principal balance was $80,000 and $0 at September 30, 2024 and December 31, 2023, respectively.
On
August 27, 2024, the Company issued a promissory note to a member of management. the promissory note accrues no interest. The unpaid
principal balance was $20,000 and $0 at September 30, 2024 and December 31, 2023, respectively.
At
September 30, 2024 and December 31, 2023, the aggregate related party payable was $151,000 and $159,000, respectively.
NOTE 9 —
STOCKHOLDER’S EQUITY
On June 21, 2024, the
Business Combination, among other transactions contemplated by the Business Combination Agreement, was completed. The transaction was
accounted as a reverse recapitalization in accordance with GAAP. Under this method of accounting, Redwoods was treated as the “acquired”
company for financial reporting purposes. Accordingly, for accounting purposes, the financial statements of the Combined Company represent
a continuation of the financial statements of Klotho with the Transactions treated as the equivalent of Klotho issuing shares for the
net assets of Redwoods, accompanied by a recapitalization. Under this method of accounting, Redwoods was treated as the acquired
company for financial reporting purposes. Accordingly, for accounting purposes, the Merger was treated as the equivalent of the
Company issuing shares for the net assets of Redwoods, accompanied by a recapitalization. The net assets of Redwoods
were stated at historical cost with no goodwill or other intangible assets recorded. See “NOTE 1 — Organization
and Business Description” for detail.
Equity Incentive Plan
In connection with the
Business Combination, the Company’s Board adopted, and the Company’s stockholders approved, the Equity Incentive Plan (“Equity
Incentive Plan”). Although the Company does not have a formal policy with respect to the grant of equity incentive awards to the
Company’s executive officers, the Company believes that equity awards provide Company’s executive officers with a strong link
to the Company’s long-term performance, create an ownership culture and help to align the interests of the Company’s executives
and the Company’s stockholders. In addition, Company believes that equity awards with a time-based vesting feature promote executive
retention because this feature provides incentives to Company’s executive officers to remain in Klotho’s employment during
the applicable vesting period. Accordingly, Company’s board of directors periodically reviews the equity incentive compensation
of the Company’s executive officers and from time to time may grant equity incentive awards to them.
During the three months ended September 30, 2024, the Company granted
3,144,000 shares at a weighted average fair value of $0.94 per share, with various vesting schedules, resulting in share-based compensation
expense of $1,952,851. During the nine months ended September 30, 2024 stock-based compensation expense totaled $1,990,366.
NOTE 10 —
COMMITMENTS AND CONTINGENCIES
From time to time, the
Company is subject to various legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business.
Although the outcome of the various legal proceedings and claims cannot be predicted with certainty, management does not believe that
any of these proceedings or other claims will have a material effect on the Company’s business, financial condition, results of
operations or cash flows.
Material Contracts
On November 27, 2014,
the Company signed a License Agreement and a Manufacturing and Supply Agreement for the monoclonal antibody development license and supply
agreement and related manufacturing with Reliance Life Sciences (RLS), the life science arm of Reliance Industries Pvt Ltd, the largest
private company in India. The contract expires on November 27, 2024 with a 10-year renewal option. The License Agreement entitles the
Company to pay $100,000 per product for a total of three products with milestone payments for meeting certain criteria. In addition, the
Company will pay a quarterly royalty payment of 5% on net sales of finished products. The Manufacturing and Supply Agreement contains
an estimated acquisition price of active pharmaceutical ingredients (API) of $350,000 per Kg for each product developed. As of September
30, 2024, the Company has not generated any activity under the agreement.
On October 19, 2022,
the Company signed an M&A/Capital Markets Advisory Agreement with Chardan Capital Markets to advise and assist the Company in negotiating
the terms and conditions with respect to a potential sale, purchase, merger, joint venture, business combination, material change of control,
or similar transaction involving the Company and a strategic acquirer and/or private or publicly listed entity or business, including
a Special Purpose Acquisition Company (SPAC), and with respect to any offerings of any equity, equity-linked or debt securities of the
Company or any other party to a financing transaction and perform such other financial advisory services to the Company. At the close
of the merger on June 21, 2024, the Company paid $3.0 million and 1.5 million in common shares for M&A advisory fees and deferred
underwriting fees. On August 20, 2024, the Company signed a Capital Markets Advisory Agreement with Chardan Capital Markets to assist
with additional fundraising.
On June 13, 2024, RWOD and Klotho entered into
a forward purchase agreement with (i) Meteora Capital Partners, LP (“MCP”), (ii) Meteora Select Trading
Opportunities Master, LP (“MSTO”), and (iii) Meteora Strategic Capital, LLC (“MSC” and, collectively
with MCP and MSTO, the “Seller”) (the “Forward Purchase Agreement”). Redwoods is the holder of the asset and Sponsor
and is also a counterparty to Klotho. Upon Closing of the merger on June 21, 2024 and on September 30, 2024, the value of the contract
for the Company was $0 as the contract created no receivable or obligation for the Company. On September 19, 2024, the Company modified
the settlement amount price of the contract to $2.00 and the shares held with Meteora are able to be sold at Meteora’s sole discretion,
with the reset price subject to weekly changes. The Company will assess the Company obligation and value the contract in the future periods
based on fair value and record changes on the fair value in the Condensed Consolidated Statements of Operations.
The Company entered into several employment, advisory,
and consulting agreements during the quarter. On August 15th, 2024, the Company entered into a three-year employment agreement
with Jeffrey LeBlanc, who joined the Company as Chief Financial Officer. Pursuant to the Employment Agreement, Mr. LeBlanc will receive
an annual base salary of $325,000, 100,000 shares of common stock immediately upon signing, 200,000 shares of common stock within one
year of the effective date, and 200,000 shares of common stock within two years of the effective date. On August 15th, 2024,
the Company entered into a three-year employment agreement with Peter Moriarty, who joined the Company as Chief Operating Officer. Pursuant
to the Employment Agreement, Mr. Moriarty will receive an annual base salary of $300,000, 100,000 shares of common stock immediately upon
signing, 200,000 shares of common stock within one year of the effective date, and 200,000 shares of common stock within two years of
the effective date. On September 24, 2024, the Company entered into a one-year Scientific Advisory Board agreement with Dr. Robert Langer.
Pursuant to the Scientific Advisory Board Agreement, Dr. Langer shall receive $175,000 in compensation and 225,000 shares of common stock,
immediately vested upon signing. The Company also entered into various consulting agreements to assist with pharmaceutical development
and business development with total monthly obligation to the Company of $22,000 per month as of September 30,2024 through year end.
NASDAQ Deficiencies
On August 16, 2024, the Company received two delinquency
notification letters (the “Notices”) from the Nasdaq Stock Market LLC (“Nasdaq”) due to the Company’s non-compliance
with Nasdaq Listing Rules 5450(b)(2)(C) and 5450(b)(2)(A). The Notices cite the Company’s (a) not being in compliance with the minimum
Market Value of Publicly Held Shares (“MVPHS”) requirement as set forth in Nasdaq Listing Rule 5450(b)(2)(C) and (b) not being
in compliance with the minimum Market Value of Listed Securities (MVLS) requirement as set forth in Nasdaq Listing Rule 5450(b)(2)(A).
In accordance with Nasdaq Listing Rule 5810(c)(3)(D),
the Company has been provided 180 calendar days, or until February 12, 2025, to regain compliance. To regain compliance, prior to February
12, 2025, (a) the Company’s minimum market value of publicly held shares must close at $15,000,000 or more for a minimum of 10 consecutive
business days and (b) the Company’s minimum market value of listed securities must close at $50,000,000 or more for a minimum of 10 consecutive
business days.
If the Company fails to timely regain compliance
with Nasdaq Listing Rules, the Company’s common stock will be subject to delisting from Nasdaq. As part of its compliance plan,
the Company is evaluating a change in Nasdaq listing tiers and alternate means of qualification, including but not limited to the shareholder
equity standard of qualification.
On October 15, 2024, the Company received a delinquency
notification letter (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”) due to the failure of the Company’s
common stock to maintain a minimum bid price of $1 per share for 30 consecutive business days as required by Nasdaq Listing Rule 5450(a)(1).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A),
the Company has been provided 180 calendar days, or until April 14, 2025, to regain compliance. To regain compliance, prior to April 14,
2025, the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days.
If the Company fails to timely regain compliance
with Nasdaq Listing Rules, the Company’s common stock will be subject to delisting from Nasdaq.
NOTE 11 — SUBSEQUENT
EVENTS
The
Company has evaluated subsequent events pursuant to the requirements of ASC Topic 855, from the balance sheet date through the date the
financial statements were issued, and has determined that the following subsequent event exists:
| ● | Key Executive Employment Agreement
– Joseph Sinkule, Chief Executive Officer - On October 24, 2024, Dr. Joseph Sinkule, the Company’s Chief Executive Officer,
entered into a new three-year employment agreement with the Company. Pursuant to the Employment Agreement, Dr. Sinkule will receive an
annual base salary of $360,000, and will receive an equity award of 1,000,000 options pursuant to the Company’s 2023 Incentive Plan.
The options are valid for a period of three (3) years and have an exercise price equal to the closing price of the Company’s common
stock on October 24, 2024. In addition, Dr. Sinkule will be eligible to participate in the Company’s annual bonus program for executives. |
| ● | Teleost
Biopharmaceuticals – On November 8, 2024, the Company and Teleost Biopharmaceuticals,
LLC mutually agreed to terminate a Licensing Agreement dated January 28, 2023 granting the
Company certain rights to develop and commercialize certain patent rights previously licensed
to Teleost and know-how rights owned by Teleost in the field of gamma-melanocortins comprised
of drug and peptide chemicals, API and pharmaceuticals that bind, affect, and potentially
treat diseases directly or indirectly related to human MC1R receptors. The Company sought
the termination of the Licensing Agreement since the licensed rights are no longer core to
the Company’s business and research plans. This termination did not result in a financial
impact for the Company. |
| ● | Scientific Advisory Board – On November 11, 2024, the Company appointed an additional advisor to our Scientific Advisory Board with annual compensation of $36,000. |
| ● | Convertible Promissory Note – On November 14, 2024, the Company signed a Securities Purchase Agreement (SPA) tied to a Convertible Promissory Note with Austria Capital LLC in the amount of $1.2 million with an original issue discount of 20%, or a net amount of $1,000,000 for the Company. The Note will be due in November 2025. On November 15, 2024, the Company received a subscription advance in the amount of $100,000. The Company expects to close the transaction by November 22, 2024. |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
References
in this report (this “Quarterly Report”) to “we,” “us” or the “Company” refer to Klotho
Neurosciences, Inc. References to our “management” or our “management team” refer to our officers and directors.
The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction
with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this Quarterly Report. Certain
information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Special
Note Regarding Forward-Looking Statements
This
Quarterly Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected
and projected. All statements, other than statements of historical fact included in this Quarterly Report, including, without limitation,
statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding
the search for an initial business combination, the Company’s financial position, business strategy and the plans and objectives
of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,”
“intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify
such forward-looking statements. Such forward-looking statements relate to future events or future performance, but reflect management’s
current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ
materially from the events, performance and results discussed in the forward-looking statements. For information identifying important
factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to
the Risk Factors section of the Company’s final prospectus for its initial public offering filed with the U.S. Securities and Exchange
Commission (the “SEC”). The Company’s filings with the SEC can be accessed on the EDGAR section of the SEC’s
website at www.sec.gov. Except as expressly required by applicable securities law, the Company disclaims any intention or obligation
to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Overview
Klotho
Neurosciences, Inc. (“The Company” or “Klotho”) develops essential medicines for the treatment of chronic diseases
– cancer, cardiovascular, and neurodegenerative disorders. The Company currently has acquired two licensed platforms: a generic
drug portfolio and a biosimilar biologics platform that uses biologic therapies to treat cancer, and two proprietary, patented technologies
involving the melanocortin receptor-binding molecules and a gene therapy platform which uses a gene therapy approach to introduce a therapeutic
protein called “Klotho” inside the body to treat neurodegenerative diseases.
Effective
September 17, 2024, the Company changed its legal name from ANEW Medical, Inc. to Klotho Neurosciences, Inc. This name change was approved
by the Company’s Board of Directors to better reflect the strategic focus of its proprietary products. Throughout these financial
statements, references to the ‘Company’ refer to Klotho Neurosciences, Inc., formerly known as ANEW or ANEW Public. Under
certain circumstances, references to ANEW and ANEW Public have remained when useful in describing the sequence of events that occurred
during the merger between Redwoods and ANEW.
As of May 30, 2023, Redwoods Acquisition Corp., a Delaware corporation
and a special purpose acquisition company (“Redwoods”), Anew Medical Sub, Inc., a Wyoming corporation (“Merger Sub”)
and ANEW Medical, Inc., a Wyoming corporation (“ANEW”) entered into a Business Combination Agreement, which was amended as
of November 4, 2023 (the “Business Combination Agreement”). On June 21, 2024 (the “Closing Date”), Merger Sub
merged with and into ANEW, with ANEW continuing as the surviving corporation and as a wholly owned subsidiary of Redwoods (the “Business
Combination”). In connection with the Business Combination, on June 21, 2024, Redwoods filed a Second Amended Certificate of Incorporation
with the Delaware Secretary of State, and adopted the amended and restated bylaws (the “Amended and Restated Bylaws”), which
replaced Redwoods’ Charter and Bylaws in effect as of such time. In connection with the closing of the Business Combination (the
“Closing”), Redwoods changed its name to “ANEW Medical, Inc.”
Critical
Accounting Policies and Estimates
See
Item 1, Note 2 – “Summary of Significant Accounting Policies.”
Results
of Operations
For
accounting purposes, the transactions contemplated by the Business Combination are treated as a reverse acquisition and, as such, the
historical financial statements of the accounting acquirer Klotho will become the historical financial statements of Public ANEW. Under
this method of accounting, Redwoods was treated as the acquired company for financial reporting purposes. Accordingly, for
accounting purposes, the Merger was treated as the equivalent of the Company issuing shares for the net assets of Redwoods,
accompanied by a recapitalization. The net assets of Redwoods were stated at historical cost with no goodwill or other intangible
assets recorded.
We
have not generated any operating revenues to date. To date, the Company’s operations have consisted of acquiring our licensed platforms
and patents, and planning for the Business Combination. We incur expenses as a result of being a public company (for legal, financial
reporting, accounting and auditing compliance), as well as our expenses associated with planning our research and clinical testing operations.
Results
of Operations for the Three and Nine Months Ended September 30, 2024 Compared to the Three and Nine Months Ended September 30, 2023
Revenues
The
Company had no revenue for the nine months ended September 30, 2024 and September 30, 2023.
Operating
Expenses
Operating
expenses are composed of consultant fees and professional fees.
Our operating expenses for the three months ended
September 30, 2024 were $2,870,932 compared to $123,737 for the three months ended September 30, 2023, an increase of $2,747,195. The
increase was primarily due to increased share-based compensation expense.
Our operating expenses for the nine months ended
September 30, 2024 were $3,688,584 compared to $520,589 for the nine months ended September 30, 2023, an increase of $3,167,995. The
increase was primarily due to increased share-based compensation expense as well as expenses associated with our business combination
including increases in third party consulting fees and professional fees.
Net
Loss
For the three months ended September 30, 2024, we incurred a net loss
of $2,959,426 compared to a net loss of $144,111 for the three month period ended September 30, 2023. The increase in net loss was primarily
due to increased share-based compensation expense.
For the nine months ended September 30, 2024, we incurred a net loss
of $4,083,109 compared to a net loss of $580,983 for the nine month period ended September 30, 2023, an increase of $3,502,126. The increase
in net loss was primarily due to increased stock-based compensation expense as well as expenses associated with preparing for our business
combination including increases in third party consulting fees and professional fees.
Liquidity
and Capital Resources
| |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Net cash used in operating activities | |
$ | (2,002,358 | ) | |
$ | (247,406 | ) |
Net cash used in investing activities | |
| (123,497 | ) | |
| (76,325 | ) |
Net cash provided by financing activities | |
| 2,173,942 | | |
| 250,000 | |
Net increase (decrease) in cash and cash equivalents | |
$ | 48,087 | | |
$ | (73,731 | ) |
Cash, beginning of year | |
| 2,808 | | |
| 75,872 | |
Cash, end of year | |
$ | 50,895 | | |
$ | 2,141 | |
Operating
Activities
Net cash used in operating activities for the
nine months ended September 30, 2024 was $2,002,358, compared to $247,406, for the nine months ended September 30, 2023, an increase of
approximately $1,755,000. The significant increase in cash used in operating activities is primarily attributable to increases in expenses
related to the business combination and continued operating costs. We expect net cash used in operating activities to increase in the
coming periods, until our products are able to produce meaningful revenue.
Investing Activities
Net cash used in investing activities for the
nine months ended September 30, 2024 was $123,497, compared to $76,325 for the nine months ended September 30, 2023, an increase of approximately
$47,000. The increase in cash used in investing activities is primarily attributable to licensing payments made in the period.
Financing Activities
Net cash provided by financing activities for
the nine months ended September 30, 2024 was $2,173,942, which consisted of investments, proceeds from the business combination, as well
as proceeds from related parties. For the nine months ended September 30, 2023, net cash provided by financing activities was $250,000,
from repayment of an advance to a shareholder.
Liquidity, Capital Resources and Going Concern
As of September 30, 2024, the Company had cash of $50,895 and net working
capital of ($827,783).
The
Company has incurred and expects to continue to incur significant professional costs to remain as a publicly traded company and incurred
significant transaction costs related to the consummation of the Business Combination.
The
accompanying consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has
incurred significant operating losses and negative cash flows from operations since inception. As of September 30, 2024, the Company
had cash of approximately $51,000 and an accumulated deficit of approximately $8.5 million. The Company has incurred recurring
losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans.
The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue
to execute its development plans and continue operations. Without additional funding, there is substantial doubt about the Company’s
ability to continue as a going concern for twelve months from the date of these financial statements.
Off-Balance
Sheet Arrangements
We
have no obligations, assets or liabilities, which would be considered off-balance sheet arrangements as of September 30, 2024. We do
not participate in transactions that create relationships with unconsolidated entities or financial partnerships, often referred to as
variable interest entities, which would have been established for the purpose of facilitating off-balance sheet arrangements. We have
not entered into any off-balance sheet financing arrangements, established any special purpose entities, guaranteed any debt or commitments
of other entities, or purchased any non-financial assets.
Emerging
Growth Company Status
We are an “emerging growth company”,
as defined in the JOBS Act, and, for as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions
from various reporting requirements applicable to other public companies but not to emerging growth companies, including, but not limited
to, not being required to have our independent registered public accounting firm audit our internal control over financial reporting under
Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy
statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval
of any golden parachute payments not previously approved. As an emerging growth company, we can also delay adopting new or revised accounting
standards until such time as those standards apply to private companies. We intend to avail ourselves of these options. Once adopted,
we must continue to report on that basis until we no longer qualify as an emerging growth company.
We
will cease to be an emerging growth company upon the earliest of: (i) the end of the fiscal year following the fifth anniversary of our
initial public offering; (ii) the first fiscal year after our annual gross revenue are $1.07 billion or more; (iii) the date on which
we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities; or (iv) the end of
any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of the end of the second
quarter of that fiscal year. We cannot predict if investors will find our common stock less attractive if we choose to rely on these
exemptions. If, as a result of our decision to reduce future disclosure, investors find our common stock less attractive, there may be
a less active trading market for our common stock and the price of our common stock may be more volatile.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a smaller reporting company, we are not required to make disclosures under this Item.
Item
4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management has evaluated the effectiveness
of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”)), as of September 30, 2024. Based on such evaluation, our Chief Executive Officer and Chief Financial
Officer have concluded that as of September 30, 2024, our disclosure controls and procedures were ineffective to provide reasonable assurance
that information required to be disclosed by us in the reports that we file or submit under the Exchange Act (a) is recorded, processed,
summarized and reported within the time periods specified by Securities and Exchange Commission (“SEC”) rules and forms and
(b) is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate,
to allow timely decisions regarding any required disclosure.
Management has identified control deficiencies
regarding inadequate accounting resources, the lack of segregation of duties and the need for a stronger internal control environment.
Our management believes that these material weaknesses are due to the small size of our accounting staff. The small size of our accounting
outsourced staff may prevent adequate controls in the future due to the cost/benefit of such remediation.
To mitigate the current limited resources and
limited employees, we rely heavily on direct management oversight of transactions, along with the use of external legal and accounting
professionals. As we grow, we expect to increase our number of employees, which will enable us to implement adequate segregation of duties
within the internal control framework.
These control deficiencies could result in a misstatement
of account balances that would result in a reasonable possibility that a material misstatement to our financial statements may not be
prevented or detected on a timely basis. In light of this material weakness, we performed additional analyses and procedures in order
to conclude that our financial statements for the quarter ended September 30, 2024, included in this Quarterly Report on Form 10-Q were
fairly stated in accordance with GAAP. Accordingly, management believes that despite our material weaknesses, our financial statements
for the quarter ended September 30, 2024, are fairly stated, in all material respects, in accordance with GAAP.
Changes in Internal Control Over Financial
Reporting
There were no changes in our internal control
over financial reporting during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
As
a smaller reporting company, we are not required to make disclosures under this Item.
Item
2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
During the three months ended September 30, 2024,
the Company’s Board of Directors adopted an Insider Trading Policy which applies to the Company’s officers, directors, employees
and consultants, a copy of which is attached hereto as Exhibit 19.1, to this Quarterly Report on Form 10-Q and incorporated herein by
reference.
Item
6. Exhibits
The
following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report.
* |
Filed
herewith. |
** |
Furnished
herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being
filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings
of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
KLOTHO NEUROSCIENCES,
INC. |
|
|
|
Date:
November 19, 2024 |
By: |
/s/
Joseph A. Sinkule |
|
Name:
|
Joseph
A. Sinkule |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
November 19, 2024 |
By: |
/s/
Jeffrey LeBlanc |
|
Name: |
Jeffrey
LeBlanc |
|
Title: |
Chief
Financial Officer
(Principal
Accounting Officer) |
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To: All Company Officers,
Directors, Employees, Consultants and Temporary Insiders:
This Confidentiality and Insider
Trading Policy (this “Policy”) describes the standards of Klotho Neurosciences, Inc. (the “Company”) on trading,
and causing the trading of, the Company’s securities or securities of certain other publicly-traded companies while in the possession
of confidential information.
One of the principal purposes
of the federal securities laws is to prohibit so-called “insider trading.” Simply put, insider trading occurs when a person
uses material non-public information obtained through involvement with the Company to make decisions to purchase, sell, give away or otherwise
trade the Company’s securities or to provide that information to others outside the Company. Serious problems could be caused for
the Company by unauthorized disclosure of internal information about the Company, including problems relating to improper trading in Company
stock. Company personnel should not discuss internal Company matters or developments with anyone outside of the Company, except as required
in the performance of regular corporate duties. Care should also be taken to avoid inadvertent disclosure of confidential information,
such as through conversations that may be overheard.
The prohibition on disclosure
of confidential information applies specifically (but not exclusively) to inquiries about the Company that may be made by the financial
press, investment analysts or others in the financial community. It is important that all such communications on behalf of the Company
be through an appropriately designated officer under carefully controlled circumstances. Unless you are expressly authorized to the contrary,
if you receive any inquiries of this nature, you should decline comment and refer the inquirer to the Company’s Chief Executive
Officer or Chief Financial Officer.
1. Our Policy Against Trading
on Undisclosed Information. If a director, officer, employee, consultant or temporary insider has material non-public information
relating to our Company, this Policy and governing law prohibit such person, or any related person, from buying or selling securities
of the Company (or engaging in any other action to take advantage of that information or pass that information on to others) until the
third business day after the date all material non-public information concerning the Company known to such person has been publicly announced
in a press release or filing with the Securities and Exchange Commission (the “SEC”). This Policy and governing law also prohibit
trading in the securities of other companies such as potential acquisition candidates or our customers or suppliers about which you have
material, non-lpublic information as a result of your employment or you consulting assignment.
Transactions that may be necessary
or justifiable for independent reasons (such as the need to raise money for an emergency expenditure) are no exception. Even the appearance
of any improper transaction must be avoided to preserve our reputation for adhering to the highest standards of conduct.
Either positive or negative
information may be material. Material information is not limited to historical facts but may also include projections and forecasts. With
respect to a future event, such as a merger, acquisition or introduction of a new product, the point at which negotiations or product
development are determined to be material is determined by balancing the probability that the event will occur against the magnitude of
the effect the event would have on a company's operations or stock price should it occur. Thus, information concerning an event that would
have a large effect on stock price, such as a merger, may be material even if the possibility that the event will occur is relatively
small. When in doubt about whether particular non-public information is material, presume it is material. If you are unsure whether
information is material, you should consult the Chief Executive Officer or Chief Financial Officer before making any decision to disclose
such information (other than to persons who need to know it) or to trade in or recommend securities to which that information relates.
To increase compliance with
the insider trading laws, the Company has created a Trading Window policy. The Trading Window opens at the close of business on the second
trading day following the date the financial results for a particular fiscal quarter or year are disclosed to the general public and closes
at the close of business on the fourteenth day of the third calendar month of that fiscal quarter.
The preferred period for transacting
in the Company’s securities, assuming the absence of material non-public Information at the time, is generally the first ten days
of each Trading Window.
You will be notified quarterly
when the Trading Window opens and closes, you should know, however, that even during the Trading Window, if you have knowledge of material
non- public information concerning the Company, you may not transact in the Company’s securities until the close of business of
the second trading day following the date such information has been disclosed to the general public or ceases to be material non-public
Information. Transacting in the Company’s securities during the Trading Window should not be considered a “safe harbor,”
and you should use good judgment at all times.
When a request for pre-clearance
is made, the requestor should carefully consider whether he or she may be aware of any material, non-public information about the Company,
and should describe fully those circumstances to the Chief Executive Officer or Chief Financial Officer. The requestor should also indicate
whether he or she has effected any non-exempt “opposite-way” transactions within the past six months, and should be prepared
to report the proposed transaction on an appropriate Form 4 or Form 5. The requestor should also be prepared to comply with SEC Rule 144
and file Form 144, if necessary, at the time of any sale.
Pre-cleared trades must be
effected within five business days of receipt of pre- clearance unless an exception is granted. Transactions not effected within the time
limit would be subject to pre-clearance again. The requestor receiving clearance for a trade should notify the Chief Executive Officer
or Chief Financial Officer of the completion of the transaction.
2. Prohibition Against
Disclosure of Nonpublic Information. The Chief Executive Officer and Chief Financial Officer of the Company (the “Authorized
Personnel”) are authorized to communicate with brokers, dealers, analysts, institutional investors, shareholders, affiliates of
the foregoing and any other person that has purchased or sold, or may reasonably be expected to purchase or sell, any common stock of
the Company (collectively, “Securities Professionals and Shareholders”). Other employees, directors and temporary insiders
are not authorized to provide oral or written information to Securities Professionals and Shareholders, except at the express direction
of the Authorized Personnel. If you receive any inquiries from any Securities Professionals or Shareholders, you should decline comment
and refer the inquirer to one or more of the Authorized Personnel.
We will expect the strictest
compliance with these procedures by all personnel at every level. As set forth below, failure to observe them may result in serious legal
difficulties for you, as well as the Company.
3. Certain Exceptions.
The Policy set forth in Section 1 does not apply in the case of the following transactions, except as specifically noted:
4. Violations of Insider
Trading Laws. Penalties for trading on or communicating material non-public information can be severe, both for individuals involved
in such unlawful conduct and their employers and supervisors, and may include jail terms, criminal fines, civil penalties and civil enforcement
injunctions. Given the severity of the potential penalties, compliance with this Policy is absolutely mandatory.
In addition, a person who
tips others may also be liable for transactions by the tippees to whom he or she has disclosed material non-public information. Tippers
can be subject to the same penalties and sanctions as the tippees, and the SEC has imposed large penalties even when the tipper did not
profit from the transaction.
The SEC can also seek substantial
civil penalties from any person who, at the time of an insider trading violation, "directly or indirectly controlled the person who
committed such violation," which would apply to the Company and/or management and supervisory personnel. These control persons may
be held liable for up to the greater of $1 million or three times the amount of the profits gained or losses avoided. Even for violations
that result in a small or no profit, the SEC can seek penalties from a company and/or its management and supervisory personnel as control
persons.
I have read and I understand
the Klotho Neurosciences, Inc. Confidentiality and Insider Trading. (the “Policy”) to which this Acknowledgment is attached.
I agree to comply with the Policy and understand that a violation of the Policy will be considered an extremely serious matter and a basis
for immediate termination.
To the attention of the Company’s Chief Executive Officer/Chief
Financial Officer
As required under the Company’s Confidentiality
and Insider Trading Policy, I am seeking pre- clearance of a transaction involving the Company’s securities.
The details of the proposed transaction are set
forth below.
Type of security (e.g. option, common stock): ____________________________
I, Joseph A. Sinkule, certify that:
In connection with the Quarterly Report of Klotho
Neurosciences, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2024, as filed with the Securities
and Exchange Commission (the “Report”), I, Joseph A. Sinkule, Chief Executive Officer of the Company, certify, pursuant to
18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
In connection with the Quarterly Report of Klotho
Neurosciences, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2024, as filed with the Securities
and Exchange Commission (the “Report”), I, Jeffrey LeBlanc, Chief Financial Officer of the Company, certify, pursuant to 18
U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge: