Item 1. Financial Statements
Item 1. Financial Statements
KLOTHO NEUROSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30,
2025
December 31,
2024
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 8,430,946
$ 63,741
Prepaid expenses
115,386
94,070
Total current assets
8,546,332
157,811
Other assets:
Licenses
2,251,134
2,251,134
Patents
48,420
48,420
Total other assets
2,299,554
2,299,554
Total assets
$ 10,845,886
$ 2,457,365
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 12,631
$ 63,686
Accrued expenses
50,331
912,095
Notes payable to related parties
-
31,000
Notes payable
-
240,753
Total current liabilities
62,962
1,247,534
Warrant liability
132,447
24,486
Total liabilities
195,409
1,272,020
Commitments and contingencies (Note 10)
STOCKHOLDERS’ EQUITY
Preferred stock, par value $ 0.0001 , 100,000,000 shares authorized; 500 and 0 issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
-
-
Common stock, par value $ 0.0001 , 1,000,000,000 shares authorized; 52,703,070 and 27,080,915 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
5,270
2,708
Additional paid-in capital
27,535,219
11,745,436
Accumulated deficit
( 16,890,012 )
( 10,562,799 )
Total stockholders’ equity
10,650,477
1,185,345
Total liabilities and stockholders’ equity
$ 10,845,886
$ 2,457,365
See accompanying notes to the unaudited condensed
consolidated financial statements.
1
KLOTHO NEUROSCIENCES, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2025
2024
2025
2024
Operating expenses:
Professional fees
$ 924,580
$ 355,752
$ 1,661,266
$ 731,348
General and administrative
339,377
2,341
694,159
48,790
Research and development
238,700
-
238,700
-
Share-based compensation
390,195
37,514
885,695
37,514
Total operating expenses
1,892,852
395,607
3,479,820
817,652
Net operating loss
( 1,892,852 )
( 395,607 )
( 3,479,820 )
( 817,652 )
Other income (expense):
Interest Expense
( 1,760,025 )
( 15,064 )
( 2,313,962 )
( 15,064 )
Change in fair value of warrant liability
( 121,476 )
( 39,697 )
( 107,961 )
( 39,697 )
Loss on conversion of debt
( 331,546 )
-
( 448,802 )
-
Other income (expense)
12,668
( 1,271 )
23,332
( 251,270 )
Total other income (expense)
( 2,200,379 )
( 56,032 )
( 2,847,393 )
( 306,031 )
Net loss before income taxes
( 4,093,231 )
( 451,639 )
( 6,327,213 )
( 1,123,683 )
Income taxes
-
-
-
-
Net loss
$ ( 4,093,231 )
$ ( 451,639 )
$ ( 6,327,213 )
$ ( 1,123,683 )
Net loss per share: Basic and Diluted
$ ( 0.12 )
$ ( 0.03 )
$ ( 0.21 )
$ ( 0.07 )
Weighted average common shares outstanding
33,952,418
15,678,898
30,755,807
15,678,898
See accompanying notes to the unaudited condensed
consolidated financial statements.
2
KLOTHO NEUROSCIENCES, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
Common Stock
Preferred Stock
(Series B, C and D)
Additional
Paid-in
Common Stock
Accumulated
Total
Stockholder’s
Equity
Shares
Amount
Shares
Amount
Capital
to be Issued
Deficit
(Deficit)
Balance, January 1, 2024*
15,130,393
$ 1,513
120,000
$ 120
$ 4,493,881
-
( 3,923,677 )
571,837
Share-based compensation
-
-
-
$ -
$ 287,251
-
-
287,251
Cancelled preferred B shares
-
-
( 30,000 )
$ ( 30 )
$ ( 38,370 )
-
-
( 38,400 )
Stock dividends
-
-
-
$ -
$ -
-
( 1,911 )
( 1,911 )
Adjustment from reverse merger application*
-
-
-
$ -
$ 213,280
-
-
213,280
Net loss
-
-
-
$ -
$ -
-
( 672,044 )
( 672,044 )
Balance at March 31, 2024*
15,130,393
$ 1,513
$ 90,000
$ 90
$ 4,956,042
$ -
$ ( 4,597,632 )
$ 360,013
Share-based compensation
-
-
-
-
37,252
262
-
37,514
Adjustment from reverse merger application*
548,505
55
( 90,000 )
$ ( 90 )
$ ( 1,780,834 )
304,200
1,911
( 1,474,758 )
Public warrants assumed from SPAC
-
-
-
-
488,750
-
( 488,750 )
-
Private warrants assumed from SPAC
-
-
-
-
( 22,525 )
-
-
( 22,525 )
Net loss
-
-
-
-
-
-
( 451,639 )
( 451,639 )
Balance at June 30, 2024
15,678,898
$ 1,568
-
$ -
$ 3,678,685
$ 304,462
$ ( 5,536,110 )
$ ( 1,551,395 )
Balance, January 1, 2025
27,080,915
$ 2,708
-
$ -
$ 11,745,436
-
$ ( 10,562,799 )
$ 1,185,345
Share-based compensation
-
-
-
-
495,500
-
-
495,500
Issuance of shares for note payable conversions
1,429,717
143
-
-
466,026
-
-
466,169
Issuance of equity warrants in connection with convertible debt
-
-
-
-
679,577
-
-
679,577
Termination of shares issued during merger under FPA agreement
-
-
-
-
46,100
-
-
46,100
Net loss
-
-
-
-
-
-
( 2,233,982 )
( 2,233,982 )
Balance at March 31, 2025
28,510,632
$ 2,851
-
$ -
$ 13,432,639
$ -
$ ( 12,796,781 )
$ 638,709
Share-based compensation
400,000
40
-
-
390,155
-
-
390,155
Issuance of common shares in connection with note conversions
6,583,757
658
-
-
1,225,455
-
-
1,226,113
Issuance of common shares in connection with warrant exercises
10,958,681
1,096
-
-
12,924,033
-
-
12,925,129
Issuance of common shares in connection with stock subscriptions
6,250,000
625
-
-
499,375
-
-
500,000
Termination of shares issued during merger under FPA agreement
-
-
-
-
94,472
-
-
94,472
Issuance of Preferred B stock for cash
-
-
500
-
500,000
-
-
500,000
Deemed dividend - warrant modification
-
-
-
-
( 1,530,910 )
-
0
( 1,530,910 )
Net loss
-
-
-
-
-
-
( 4,093,231 )
( 4,093,231 )
Balance at June 30, 2025
52,703,070
$ 5,270
500
$ -
$ 27,535,219
$ -
$ ( 16,890,012 )
$ 10,650,477
* Note: as a result of the business combination as recast, the shares of the Company’s common stock prior to the Business Combination (refer to Note 1) have been retrospectively recast to reflect the change in the capital structure as a result of the Business Combination on 6/21/24.
See accompanying notes to the unaudited condensed
consolidated financial statements.
3
KLOTHO NEUROSCIENCES, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
For the Six Months Ended
June 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 6,327,213 )
$ ( 1,123,683 )
Adjustments to reconcile net loss to net cash used in operating activities:
Changes in fair value of warrant liability
107,961
39,697
Commitment fee
-
250,000
Interest expense
2,285,080
-
Loss on conversion of note payable
448,802
-
Share-based compensation
885,695
37,514
Changes in operating assets and liabilities:
Prepaid expenses
21,316
( 150,660 )
Accounts payable
( 51,055 )
( 117,271 )
Accrued expenses
( 861,764 )
247,940
Related party payable
( 31,000 )
( 128,000 )
Other Liabilities
-
15,064
Net cash used in operating activities
$ ( 3,522,178 )
$ ( 929,399 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisition of drug license
-
( 123,497 )
Net cash used in (provided by) investing activities
$ -
$ ( 123,497 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from convertible promissory note, net of issuance cost
2,150,000
950,000
Proceeds from sales of stocks and warrants, net
11,394,218
175,000
Proceeds from stock subscriptions
500,000
-
Proceeds from sale of preferred B shares
500,000
-
Payments on notes payable
( 2,730,182 )
-
Payments for deferred financing costs
( 25,000 )
-
Proceeds from FPA settlement
140,572
-
Payments on financed director and officer insurance
( 40,225 )
-
Merger proceeds net of transaction cost
-
770,424
Net cash provided by financing activities
$ 11,889,383
$ 1,895,424
NET CHANGE IN CASH
8,367,205
842,528
Cash - Beginning of period
63,741
2,808
Cash - End of period
$ 8,430,946
$ 845,336
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES:
Note payable settled with issuance of common stock
$ 1,473,441
$ 1,308,270
Reversal of OID
681,506
-
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 income tax payable from merger
-
$ 568,111
Assumed warrant liability from merger
-
$ 22,525
Interest payable settled with issuance of common stock
57,641
$ -
Issuance of warrants
679,577
$ -
Repurchase of warrants
( 679,577 )
$ -
SUPPLEMENTAL CASH FLOW INFORMATION:
Interest Paid
$ 79,153
$ 2,460
Taxes Paid
$ -
$ -
See accompanying notes to
the unaudited condensed consolidated financial statements.
4
KLOTHO NEUROSCIENCES, INC.
NOTES TO THE UNAUDITED CONDENSED 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 a proprietary, patented gene therapy platform that
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.
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 Medical, Inc (ANEW). Under certain circumstances, references to ANEW have
remained useful when 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.
5
Recapitalization
In connection with the merger, the Company issued
six million shares in exchange for all 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 remained 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 the closing of the Business Combination
on June 21, 2024, the Company received approximately $ 181,339 in net cash proceeds.
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. The $ 2,000,000 note has been converted into shares and considered as paid in full as of December 31,
2024.
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. The
$ 2,000,000 note has been converted into shares and considered as paid in full as of December 31, 2024.
6
Certain ANEW stockholders may be entitled to up
to an additional 2,000,000 shares of Company Common Stock (the “ Contingent Consideration Shares ”), upon the following
conditions being met:
(i) 1,000,000 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
(ii) 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 December
31, 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 December 31, 2024 from the assumed $ 589,081 cash.
NOTE 2 — SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Going Concern
The accompanying unaudited condensed 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 June 30, 2025, the Company had cash of approximately $ 8.4 million and an accumulated
deficit of approximately $ 16.9 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 2024 Annual Report. Results of operations for interim periods are not necessarily
indicative of annual results.
7
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 condensed 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 June 30, 2025, the Company has not experienced losses on this account and management
believes the Company is not exposed to significant risks on such account.
8
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
assets or
liabilities (Level 1)
Significant other
observable inputs
(Level 2)
Significant unobservable inputs
(Level 3)
Assets:
Cash equivalents, June 30, 2025
$ 8,257,103
$ 8,257,103
$ -
$ -
Cash equivalents, December 31, 2024
$ -
$ -
$ -
$ -
Liabilities:
Representative warrant liabilities, June 30, 2025
$ 132,447
$ -
$ -
$ 132,447
Liabilities:
Representative warrant liabilities, December 31, 2024
$ 24,486
$ -
$ -
$ 24,486
The following tables present a reconciliation of the Level 3 Representative
Warrants liabilities:
Three Months Ended
June 30,
2025
2024
Representative warrant liabilities, April 1
$ 10,971
$ -
Change in fair value
121,476
-
Representative warrant liabilities, June 30
$ 132,447
$ -
Six
Months Ended
June 30,
2025
2024
Representative warrant liabilities, January 1
$ 24,486
$ -
Change in fair value
107,961
-
Representative warrant liabilities, June 30
$ 132,447
$ -
9
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 litigation 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, 2024, the date of the last impairment test, the Company determined that the license related to Teleost Biopharmaceutic,
LLC was impaired and recognized an impairment expense of $ 10,000 as of December 31, 2024. The Company determined that the estimated fair
value of all other intangible assets exceeded their carrying value, 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 2022, 2023 and 2024 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.
10
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 Three Months Ended
For the Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Numerator:
Net loss
$ ( 4,093,231 )
$ ( 451,639 )
$ ( 6,327,213 )
$ ( 1,123,683 )
Weighted-average common shares outstanding, basic and diluted
33,952,418
15,678,898
30,755,807
15,678,898
Basic and diluted loss per share
$ ( 0.12 )
$ ( 0.03 )
$ ( 0.21 )
$ ( 0.07 )
The following common share equivalents are excluded
from the calculation of weighted average common shares outstanding, because their inclusion would have been anti-dilutive:
As of June 30,
2025
2024
Warrants
5,071,319
12,030,000
Preferred Shares B
6,250,000
-
Total potentially dilutive shares
11,321,319
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 $ 238,700 and $0 for the three and six months ended June 30, 2025 and 2024, 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
and stock options to employees and consultants for their services. Costs 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 $ 390,195 and $ 37,514
for the three months ended June 30, 2025, and 2024, respectively. The Company recorded share-based compensation of $ 885,695 , and $ 37,514
for the six months ended June 30, 2025 and 2024, respectively.
Warrants
As of June 30, 2025, the fair value of the Representative
Warrant liabilities was $ 132,447 based on the closing price of the warrants on The Nasdaq Capital Market. The fair value of the Representative
Warrants was approximately $ 0.25 per Representative Warrant as of June 30, 2025, which was based on the relative fair value to the Public
Warrants. During the three months ended June 30, 2025, the fair value of the Representative warrants increased by $ 121,476 . During the
six months ended June 30, 2025, the fair value of the Representative warrants increased by $ 107,961 .
11
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.
Segment Information
Operating segments are defined as components of
an enterprise for which separate discrete information is available for evaluation by the Chief Operating Decision Maker (“CODM”)
or decision-making group in deciding how to allocate resources and in assessing performance. The Company views its operations and manages
its business as one operating and reporting segment, which is the business of research and development of essential medicines for the
treatment of chronic diseases – cancer, cardiovascular, and neurodegenerative disorders. See Note 11 Segment Information for additional
information.
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial
Instruments – Credit Losses, which requires entities to estimate all expected credit losses for financial assets measured
at amortized cost basis, including trade receivables, held at the reporting date based on historical experience, current conditions, and
reasonable and supportable forecasts. The Company adopted this guidance on January 1, 2023. The adoption of this accounting standard did
not have an impact on the Company’s consolidated financial statements as the Company is in a pre-revenue state and does not generate
revenue and has no receivables from third party.
In November 2023, the FASB issued ASU 2023-07, Segment
Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires incremental disclosure of segment information
on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim
periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial
statements is required for public entities. The Company adopted ASU 2023-07 as of January 1, 2024, which resulted in additional disclosures
of significant segment expenses and other segment items as well as incremental qualitative disclosures.
NOTE 3 — PREPAID EXPENSES
Prepaid expenses consist of prepayment of the
premium on Directors and Officers insurance, NASDAQ annual fees, association membership fees, and Delaware franchise taxes. As of June
30, 2025 and December 31, 2024, prepaid expenses totaled $ 115,386 and $ 94,070 , respectively, in the accompanying condensed consolidated
balance sheets.
12
NOTE 4 — INTANGIBLE ASSETS
Intangible assets consisted of the following:
Intangible Assets
June 30,
2025
December 31,
2024
Licenses
Non-Exclusive License Agreement
$ 179,821
$ 179,821
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
$ 2,299,554
$ 2,299,554
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 31 st each year during the term of the agreement for each licensed product for the proceeding calendar year. The value of the licenses was $ 179,821 at June 30, 2025 and December 31, 2024, respectively.
● Various Generic Drugs ($ 736,983 ) - During 2015, the Company acquired two licenses for biosimilar biologic therapies to treat cancer and autoimmune diseases. The value of the licenses was $ 736,983 at June 30, 2025 and December 31, 2024, respectively.
● 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 June 30, 2025 and December 31, 2024.
● 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 under the agreement is $ 26,060 at June 30, 2025 and December 31, 2024, respectively.
● 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. The patent value, which is part of licenses in the accompanying condensed consolidated balance sheet, as of June 30, 2025 and December 31, 2024, 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 annual license fee is 10,000 Euros. In addition, the Company will pay a Royalty equal to 3 % of net sales of finished products once the license is in use. As of June 30, 2025 and December 31, 2024, the Company owed $ 0 under the agreement.
These licenses and patents are not currently in
use as the Company is in 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 later in the year.
13
NOTE 5 — ACCOUNTS PAYABLE AND ACCRUED
EXPENSES
Accounts payable and accrued expenses consist of professional fees.
The accounts payable and accrued expenses as of June 30, 2025 and December 31, 2024 were $ 62,962 and $ 975,781 , respectively, in the accompanying
condensed consolidated balance sheet.
NOTE 6 — NOTES PAYABLE TO RELATED PARTIES
Notes payable to related parties consisted of
the following:
June 30,
2025
December 31,
2024
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
Total notes payable to related parties
$ -
$ 31,000
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 in full as of June 30, 2025. The unpaid principal balance was $0 and $ 31,000 at
June 30, 2025 and December 31, 2024, respectively.
NOTE 7 — NOTES PAYABLE
Upper Clapton Convertible Promissory Note
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 outstanding principal balance of the note was $ 0 at June 30, 2025 and December 31, 2024, respectively.
Redwoods PIPE Investor Convertible Promissory
Note
On March 4, 2024, in connection with the Merger,
Public ANEW entered into a convertible promissory note that bore an interest of 10 % 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.
The note and related interest were converted into the Company’s common shares and fully settled as of September 30, 2024. The outstanding
principal balance as of June 30, 2025 and December 31, 2024 was $ 0 , respectively.
ANEW PIPE Investors Convertible Promissory
Note
On April 22, 2024, prior to the closing of the
Business Combination Agreement, ANEW Medical (Wyoming) entered into a convertible promissory note that bore an interest of 10 % 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 years ended December 31, 2024. The note and related interest were converted into the Company’s common shares
and fully settled as of September 30, 2024. The outstanding principal balance as of June 30, 2025 and December 31, 2024 was $ 0 , respectively.
14
Austria Capital LLC Convertible Promissory
Note
On December 4, 2024, the Company entered into
a convertible promissory note (“the note”) with a principal amount of $ 1,200,000 pursuant to the terms of a securities purchase
agreement by and between the Company, as issuer, and Austria Capital LLC, as investor (“Investor”). The maturity date of the
note is December 4, 2025. The note bears no interest, has an original issue discount of $ 200,000 and deferred financing costs related
to legal fees of $ 73,000 . In addition, the note offered the investor an equity inducement of two million shares, which were issued to
the Investor and valued at $ 978,000 . The total of the original issue discount, deferred financing costs and equity inducement, exceeded
the principal balance by approximately $ 51,000 , which was expensed as an interest expense on the condensed consolidated statements of
operations. Total amortization of these costs recognized as contra-liabilities to be presented net with the principal liability on the
condensed consolidated balance sheets was $ 100,000 at December 31, 2024.
At any time after the approval by the Company’s
stockholders, at the option of the Investor, the outstanding principal amount of the note or any portion thereof, is convertible into
shares of the Company’s common stock at a price of $ 0.25 per share; provided that no conversions can take place if the Investor
then owns more than 4.99 % of the number of the shares of the Company’s common stock outstanding. The conversion price is subject
to adjustment in connection with certain transactions, including stock splits or combinations and the like.
Pursuant to the terms of the Sale Purchase Agreement,
the Company issued to the Investor a total of 2,000,000 shares of the Company’s common stock as an inducement to the Investors to
purchase the note. Such shares were issued in reliance upon Section 4(a)(2) of the Securities Act in a transaction not involving any public
offering.
The note was paid off in full as of June 30, 2025
and net liability as of June 30, 2025 and December 31, 2024 was approximately $ 0 and $ 100,000 , respectively.
Red Road Holdings Promissory Note
On December 10, 2024, the Company signed a loan
agreement with Red Road Holdings in the amount of $ 203,324 , including guaranteed interest of $ 21,784 . In connection with the note issuance,
an original issue discount of $ 25,040 was recognized as well as deferred financing costs related to legal fees of $ 6,500 . The net liability
presented on the condensed consolidated balance sheet was $ 181,722 as of June 30, 2024 as a result of amortization of $ 17,515 recognized
in interest expense on the condensed consolidated statement of operations for the year ended June 30, 2025. As of June 30, 2025, the net
liability presented on the condensed consolidated balance sheet was $ 0 as the note was paid off in full, including interest expense composed
of $ 21,784 interest, $ 25,040 original issue discount, and related legal fees of $ 6,500 .
On January 3, 2025, the Company signed a loan
agreement with Red Road Holdings in the amount of $ 137,715 , including guaranteed interest of $ 14,755 . In connection with the note issuance,
an original issue discount of $ 16,960 was recognized as well as deferred financing costs related to legal fees of $ 6,000 . The promissory
note is due on November 15, 2025. The note is convertible to shares in the event of default. As of June 30, 2025, the net liability presented
on the condensed consolidated balance sheet was $ 0 as the note was paid off in full, including interest expense composed of $ 14,755 interest,
$ 16,960 original issue discount, and related legal fees of $ 6,000 .
On April 4, 2025, the Company signed a loan agreement
with Red Road Holdings in the amount of $ 106,534 , including guaranteed interest of $ 11,414 . In connection with the note issuance, an original
issue discount of $ 13,120 was recognized. as well as deferred financing costs related to legal fees of $ 7,000 . The promissory note is
due on January 30, 2026. The note is convertible to shares in the event of default. As of June 30, 2025, the net liability presented on
the condensed consolidated balance sheet was $ 0 as the note was paid off in full, including interest expense composed of $ 11,414 interest,
$ 13,120 original issue discount, and related legal fees of $ 7,000 .
3i LP Institutional Investor Securities Purchase
Agreement
On January 23, 2025 (the “Closing Date”)
the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”),
pursuant to which the Investor will purchase, for an aggregate purchase price of $ 2,000,000 , two senior convertible promissory notes (the
“Notes”) from the Company in the aggregate principal amount of $ 2,173,914 and two warrants (the “Warrants”) to
purchase up to an aggregate of 4,000,000 shares of the Company’s common stock, par value $ 0.0001 per share, in each case subject
to the terms and conditions set forth in the Purchase Agreement. Upon effectiveness of the registration rights agreement (the “Registration
Rights Agreement”) executed by the Company and the Investor on the Closing Date, the Company filed a registration statement with
the Securities and Exchange Commission (“SEC”) to register the shares of Common Stock issuable to the Investor upon any conversion
of the Notes or exercise of the Warrants, within 15 days of the Closing Date. Pursuant to the Purchase Agreement, upon the registration
statement being declared effective by the SEC on February 10, 2025, the Investor purchased a second Note in the principal amount of $ 1,086,957
and a second Warrant exercisable for up to an aggregate of 2,000,000 shares of Common Stock, for an aggregate purchase price of $ 1,000,000
on February 13, 2025.
15
The Notes mature on the anniversary of their date
of issuance, unless prior thereto there is an event of default, bear interest at a rate of 7 % per annum, have an 8 % original issuance
discount, are an unsecured obligation of the Company and rank equal in right of payment with the Company’s existing indebtedness
and senior to any future debt obligations of the Company through the repayment of the Notes. The outstanding principal amount of the Notes
or any portion thereof is convertible into shares of Common Stock at a price of $ 0.25 per share (the “Conversion Price”);
provided that no conversions can take place if the Investor then owns more than 4.99 % (or up to 9.99 % pursuant the terms of the Notes)
of the number of the shares of Common Stock outstanding (the “Maximum Percentage”). Further, no conversion can take place,
prior to approval by the Company’s stockholders, if such conversion would violate any rule of the Nasdaq Stock Market. The Conversion
Price is subject to adjustment in connection with certain transactions, including stock dividends, stock splits or combinations and the
like. The Notes contain certain specified events of default, the occurrence of which would entitle the Investor to immediately demand
repayment of all outstanding principal such as certain events of bankruptcy, insolvency and reorganization involving the Company.
The Warrants expire five years from their respective dates of issuance.
The Warrants were exercisable, at the option of the holder, at any time, for up to an aggregate of 4,000,000 shares of Common Stock of
the Company at an exercise price equal to $ 0.50 , subject to adjustment for any stock splits, stock dividends, recapitalizations, and similar
events.
On April 30, 2025, the Company made installment
payments in cash totaling $ 232,608 on both 3i Notes or $ 116,304 for each 3i note, including principal, interest and make whole. The note
was paid off in full as of June 30, 2025 and net liability as of June 30, 2025 and December 31, 2024 was approximately $ 0 , respectively.
Conversions
As of June 30, 2025, investors converted convertible promissory notes
related to Austria Capital totaling $ 650,000 through the issuance of 2,600,000 shares of common stock that were issued and outstanding
as of June 30, 2025. As of June 30, 2025, investors converted convertible promissory notes related to 3i totaling $ 881,085 through the
issuance of 5,413,474 shares of common stock that were issued and outstanding as of June 30, 2025.
During 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 that were issued and outstanding as of December 31, 2024.
NOTE 8 — RELATED PARTIES
On October 24, 2024, Dr. Joseph Sinkule and the
Company entered into an Employment Agreement for a term of three years in connection with his appointment as the Company’s Chief
Executive Officer. Pursuant to the Employment Agreement, Dr. Sinkule will receive an annual base salary of $ 360,000 and an initial equity
award of 1,000,000 options pursuant to the Company’s 2023 Incentive Plan vesting immediately. 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.
On August 15, 2024, Mr. Jeffrey LeBlanc and the
Company entered into an Employment Agreement for a term of three years in connection with his appointment as the Company’s Chief
Financial Officer, Pursuant to the Employment Agreement, Mr. LeBlanc will receive an annual base salary of $ 325,000 and an initial equity
award of shares of the Company’s common stock of 100,000 shares and an additional equity award of 400,000 shares of the Company’s
common stock, with 200,000 of such shares vesting on the first anniversary of the agreement and 200,000 of such shares vesting on the
second anniversary of the agreement. In addition, Mr. LeBlanc will be eligible to participate in the Company’s annual bonus program
for executives.
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 $ 0 and $ 31,000 at June 30, 2025 and December 31, 2024, respectively.
At June 30, 2025 and December 31, 2024, the aggregate
related party payable was $0 and $ 31,000 , respectively.
16
NOTE 9 — STOCKHOLDER’S EQUITY
On June 21, 2024, the Business Combination 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. 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.
Warrants
During the three months ended June 30, 2025, the Company initiated
a warrant exercise inducement program, reducing the exercise price from $ 3.49 to $ 1.35 for certain outstanding warrants. The Company accounted
for the inducement as a modification of the original warrants in accordance with ASC 505-10 - Equity. The incremental fair value was recorded
as a deemed dividend of $ 0.3 million in accumulated deficit on the condensed consolidated balance sheets. During the three months ended
June 30, 2025, holders of common stock warrants exercised a total of 11.0 million warrants for gross proceeds of $ 11.4 million.
Austria Note Conversion
During the three months ended June 30, 2025, $ 650,000 of principal
related to the Austria Capital LLC Convertible Promissory Note was converted into 2,600,000 shares of common stock at a conversion price
of $ 0.25 . The remainder of the note in the amount of $ 550,000 was settled in cash. Therefore, the Company de-recognized the remaining
unamortized original issue discount of $ 85,554 and deferred financing costs of $ 438,471 , which were recognized in interest expense on
the condensed consolidated statements of operations.
3i Note Conversion
During the six months ended June 30, 2025, $ 823,444 of principal and
$ 57,641 of interest and make whole related to 3i convertible notes was converted into 5,413,474 shares of common stock at conversion prices
ranging from $ 0.12 to $ 0.25 .
17
Investor Share Purchase
On June 5, 2025, the Company entered into a securities purchase agreement
an accredited investor pursuant to Regulation D of the Securities Act of 1933, as amended. Under the terms of the agreement, the Company
issued 6,250,000 shares of its common stock at a purchase price of $ 0.08 per share, for total gross proceeds of $ 500,000 . The proceeds
were allocated to common stock based upon their par value of the common stock and the remainder in recorded to additional paid in capital
on the condensed consolidated balance sheets.
Preferred B Shares
On June 9, 2025, the Company conducted a private
offering and issued 500 preferred B shares at $ 0.0001 par value per share for a total of $ 500,000 . The 500 preferred shares are convertible
into 6,250,000 common shares.
Meteora Agreement
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 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 allowed
the shares held with Meteora to be sold at Meteora’s sole discretion, with the reset price subject to weekly changes. During the
quarter ending March 31, 2025, Meteora sold and terminated on behalf of the Company 100,000 shares at a reset price of $ 0.4610 , for total
proceeds to Klotho in the amount of $ 46,100 . On May 15, 2025, Meteora terminated additional 550,214 shares at a reset price of $ 0.1717
for total proceeds of $ 94,472 , thereby reducing the number of shares per the agreement to 10,000 shares remaining.
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.
Termination of acquisition agreement of SB
Security Holdings, LLC
On March 26, 2025, the Company entered into a
Share Exchange Agreement (the “SEA”) to acquire SB Security Holdings, LLC, a Delaware limited liability company (“SBSH”),
which is an internet connected video doorbell service company. Pursuant to the SEA, the Company agreed to purchase all of the issued and
outstanding membership interests in SBSH (the “Acquisition”) in exchange for a number of newly issued shares of the Company’s
common stock equal to ninety percent ( 90 %) of the total number of issued and outstanding shares of the Company’s common stock, on
a fully-diluted basis, as of the closing of the Acquisition. The closing of the Acquisition is subject to customary closing conditions,
including mutual agreement as to the legal transaction structure, approval by the Company’s stockholders, and Nasdaq approval. On
June 13, 2025, the Company terminated the SEA.
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.
On October 15, 2024, the Company received a delinquency
notification letter (the “Notice”) from Nasdaq due to the Company’s non-compliance with Nasdaq Listing Rule 5450(a)(1).
The Notice cited the fact that the bid price of the Company’s common stock had closed at less than $ 1 per share over the previous
30 consecutive business days.
On June 30, 2025, subsequent to a Nasdaq Listing
Qualifications Hearing conducted on March 28, 2025, the Company received notice from the Nasdaq Listing Qualifications Panel that the
Panel had granted the Company’s request to continue its listing on The Nasdaq Stock Market (“Nasdaq” or the “Exchange”)
subject to becoming compliant by August 13, 2025. The Company received a letter of compliance on July 14, 2025.
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NOTE 11 — SEGMENT INFORMATION
Operating segments are defined as components of
an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”)
in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as a single reporting
segment, focused on developing 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.
The Company’s measure of segment profit
or loss is net loss. The CODM is the chief executive officer (“CEO”). The CODM manages and allocates resources to the operations
of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall
level of resources available and how to best deploy these resources across functions and research and development projects that are in
line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses consolidated
financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources, and setting
incentive targets. Operating expenses are used to monitor budget versus actual results. The CODM also uses net loss in competitive analysis
by benchmarking to the Company’s peer group. The competitive analysis along with the monitoring of budgeted versus actual results
are used in assessing performance of the segment.
The following table is representative of the significant
expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to the
consolidated net loss for the periods ended June 30, 2025 and 2024 is included at the bottom of the table below.
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2025
2024
2025
2024
Significant segment expenses
General and administrative (1)
$ 339,377
$ 2,341
$ 694,159
$ 48,790
Research and development
238,700
-
238,700
-
Professional fees - Licenses and Patents
-
1,502
-
288,416
Professional fees - Other
924,580
354,250
1,661,266
442,932
Share-based compensation expense
390,195
37,514
885,695
37,514
Interest expense (income)
1,760,025
15,064
2,313,962
15,064
Other segment items
318,878
1,271
425,470
251,270
Total operating and segment expenses
$ 3,971,755
$ 411,942
$ 6,219,252
$ 1,083,986
Reconciliation of net loss
Change in fair value of warrant liabilities
121,476
39,697
107,961
39,697
Consolidated net loss
$ 4,093,231
$ 451,639
$ 6,327,213
$ 1,123,683
1) Excluding share-based compensation expense
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NOTE 12 — 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:
On July 3, 2025, the U.S. Food and Drug Administration (FDA) granted
Orphan Drug Designation to the company’s novel secreted-Klotho (s-KL) promoter, gene and delivery system (KLTO-202, or s-KL-AAV.myo)
for the treatment of ALS. The Orphan Drug Designation provides certain incentives to the Company, such as tax credits, toward the cost
of human clinical trials and a waiver for the payment of the GDUFA User Fee for market applications. Additionally, Orphan Drug Designation
of the product provides developers with seven years of US market exclusivity and independent from the Company’s intellectual property
protection.
On July 3, 2025, the Company entered into a sales agreement with A.G.P./Alliance
Global Partners (“A.G.P.”) relating to the sale of newly issued shares of the Company’s common stock. In accordance
with the terms of the sales agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of
up to $ 50,000,000 from time to time through A.G.P., acting as the Company’s sales agent or principal. The Company intends to use
the net proceeds from the offering for working capital and for general corporate purposes.
On July 7, 2025, the Company filed a Form S-3 Registration Statement
with the U.S. Securities Exchange Commission (“SEC”) that allows the Company to offer shares of common stock, preferred stock,
warrants to purchase common stock or preferred stock, and/or units to purchase any of such securities, either individually or in combination
with other securities described in this prospectus, in one or more offerings from time to time, with a total value of up to $ 100,000,000 .
The Form S-3 was declared effective on July 25, 2025.
On July 8, 2025, the Board of Directors determined that the Company
had met the criteria set forth in the Business Combination Agreement for the release of 2,000,000 contingent shares to the pre-closing
stockholders of ANEW Medical. The 2,000,000 shares were issued on August 5, 2025. In addition, the Board of Directors approved the issuance
of 408,691 from in the Company’s Equity Incentive Plan to Jeffrey LeBlanc, the Company’s CFO.
On July 14, 2025, the Nasdaq Hearings Panel (the
“Panel”) issued a letter to the Company that the Panel finds the Company in compliance with Listing Rules 5550(a)(1) and 5550(b)(1),
the “Bid Price” and “Equity Rules,” respectively. On July 16, 2025, the Company issued a press release announcing
that the Company regained compliance with the Nasdaq listing requirements. In addition, on July 14. 2025, Nasdaq approved the Company’s
application to “phase down” the listing of its common stock and warrants from the Nasdaq Global Market to the Nasdaq Capital
Market. The Company’s common stock will continue to trade under the symbol “KLTO” and the Company’s warrants will
continue to trade under the symbol “KLTOW.”
On July 21, 2025, the Company signed a one-year lease in the amount
of $ 8,400 for an office space in Charlotte, NC.
On July 28, 2025, the Company filed with the SEC a Supplemental Prospectus
under the Form S-3 Registration Statement to register for resale an aggregate 12,500,000 Shares of Common Stock of the Company, which
consists of 6,250,000 shares of Common Stock previously sold to two investors in a transaction exempt from the registration requirements
of the Securities Act and 6,250,000 shares of Common Stock issuable upon the conversion of shares of the Company’s Series B Preferred
Stock sold to an investor in a transaction exempt from the registration requirements of the Securities Act.
On July 28, 2025, the Company filed with the SEC a Supplemental Prospectus
under the Form S-3 Registration Statement to register for the offer and sell shares of up to $ 50,000,000 in common stock, from time to
time, through A.G.P., acting as the Company’s sales agent or principal. The sales of the common stock, if any, under the prospectus
supplement will be made at market prices by any method deemed to be an “at the market offering.”
On August 6, 2025, Klotho Neurosciences, Inc. (the “Company”)
entered into a Letter Agreement (“Agreement”) with AAVnerGene Inc. (“AAVnerGene”) for the manufacturing and development
of its KLTO-202 gene therapy candidate using the AAVnerGene platform technology. AAVnerGene is an innovation-driven biotech renowned for
its transformative technologies in adeno-associated viruses (AAV) manufacturing and tissue-targeted delivery.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.