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 March 31, 2026
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
file number: 001-39717
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
20-2903526
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
Number)
433
Plaza Real , Suite 275
Boca
Raton , FL 33432
(Address
of principal executive offices, including Zip Code)
(631)
830-7092
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock, par value $0.0001 per share
LIXT
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 May 12, 2026, the Company had 12,382,944 shares of common stock issued and outstanding.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
TABLE
OF CONTENTS
Page
Number
PART I - FINANCIAL INFORMATION
3
Item 1. Condensed Consolidated Financial Statements
3
Condensed Consolidated Balance Sheets – March 31, 2026 (Unaudited) and December 31, 2025
3
Condensed Consolidated Statements of Operations (Unaudited) – Three Months Ended March 31, 2026 and 2025
4
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) – Three Months Ended March 31, 2026 and 2025
5
Condensed Consolidated Statements of Cash Flows (Unaudited) – Three Months Ended March 31, 2026 and 2025
6
Notes to Condensed Consolidated Financial Statements (Unaudited) – Three Months Ended March 31, 2026 and 2025
7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
31
Item 3. Quantitative and Qualitative Disclosures About Market Risk
38
Item 4. Controls and Procedures
38
PART II - OTHER INFORMATION
39
Item 1. Legal Proceedings
39
Item 1A. Risk Factors
39
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
39
Item 3. Defaults Upon Senior Securities
39
Item 4. Mine Safety Disclosures
39
Item 5. Other Information
39
Item 6. Exhibits
40
SIGNATURES
41
2
PART
I - FINANCIAL INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
March 31,
December 31,
2026
2025
(Unaudited)
ASSETS
Current assets:
Cash
$ 3,250,650
$ 5,106,872
Prepaid insurance
56,031
26,682
Other prepaid expenses
101,069
44,825
Total current assets
3,407,750
5,178,379
LiGHT proton therapy system equipment
6,607,419
6,582,560
Operating lease right-of-use assets
850,129
972,682
Total assets
$ 10,865,298
$ 12,733,621
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses, including $ 37,390 and $ 125,959 to related parties at March 31, 2026 and December 31, 2025, respectively
$ 391,081
$ 436,482
Research and development contract liabilities
238,435
232,138
Operating lease obligations, current
595,418
595,418
Series B Convertible Preferred Stock 8% cumulative dividend payable
-
69,073
Total current liabilities
1,224,934
1,333,111
Operating lease obligations, long-term
461,772
438,959
Total liabilities
1,686,706
1,772,070
Commitments and Contingencies
-
-
Stockholders’ Equity:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized;
Series A Convertible Preferred Stock, $ 10.00
per share stated value – no shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively
-
-
Series B Convertible Preferred Stock, $ 0.7146
per share stated value – no shares issued and outstanding at March 31, 2026, and 2,423,130
shares issued and outstanding at December 31, 2025
-
1,731,569
Preferred Stock value
-
1,731,569
Common stock, $ 0.0001
par value; 100,000,000 shares authorized; 11,632,944
and 8,790,102 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively
1,162
879
Additional paid-in capital
67,944,759
66,008,824
Accumulated deficit
( 60,000,889 )
( 58,077,213 )
Total Lixte Biotechnology stockholders’ equity
7,945,032
9,664,059
Non-controlling interest
1,233,560
1,297,492
Total stockholders’ equity
9,178,592
10,961,551
Total liabilities and stockholders’ equity
$ 10,865,298
$ 12,733,621
See
accompanying notes to condensed consolidated financial statements.
3
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2026
2025
Three Months Ended March 31,
2026
2025
Revenues, net
$ -
$ -
Costs and expenses:
General and administrative costs
1,654,031
615,483
Research and development costs
333,376
91,457
Total costs and expenses
1,987,407
706,940
Loss from operations
( 1,987,407 )
( 706,940 )
Other income (expenses):
Interest Income
3,370
441
Interest Expense
( 3,096 )
( 3,135 )
Foreign currency gain (loss)
( 475 )
79
Other income
Net loss
$ ( 1,987,608 )
$ ( 709,555 )
Series B Convertible Preferred Stock 8% cumulative dividend
( 17,882 )
-
Non-controlling interest
$ 63,932
$ -
Net loss attributable to common stockholders
$ ( 1,941,558 )
$ ( 709,555 )
Net loss per common share – basic and diluted
$ ( 0.18 )
$ ( 0.29 )
Weighted average common shares outstanding – basic and diluted
10,889,003
2,471,513
See
accompanying notes to condensed consolidated financial statements.
4
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
interest
Equity
Series A Convertible
Preferred Stock
Series B
Convertible
Preferred Stock
Common Stock
Additional Paid in
Accumulated
Non-controlling
Total Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
interest
Equity
Balance, December 31, 2025
-
$ -
2,423,130
$ 1,731,569
8,790,102
$ 879
$ 66,008,824
$ ( 58,077,213 )
$ 1,297,492
$ 10,961,551
Exercise of pre-funded warrants
-
-
-
-
283,021
28
( 28 )
-
-
-
Fair value of shares issued for services
-
-
-
-
15,000
1
53,399
-
-
53,400
Series B Convertible Preferred Stock 8% cumulative dividend
-
-
-
-
-
-
( 17,882 )
-
-
( 17,882 )
Conversion of Series B Convertible Preferred Stock and related dividend
-
-
( 2,423,130 )
( 1,731,569 )
2,544,821
254
1,818,270
-
-
86,955
Stock-based compensation
-
-
-
-
-
-
82,176
-
-
82,176
Net loss
-
-
-
-
-
-
-
( 1,923,676 )
( 63,932 )
( 1,987,608 )
Balance, March 31, 2026
- -
$ - -
-
$ -
11,632,944
$ 1,162
$ 67,944,759
$ ( 60,000,889 )
$ 1,233,560
$ 9,178,592
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
interest
Equity
Series A
Convertible
Preferred Stock
Series B Convertible
Preferred Stock
Common Stock
Additional Paid in
Accumulated
Non-controlling
Total Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
interest
Equity
Balance, December 31, 2024
350,000
$ 3,500,000
- -
$ - -
2,249,290
$ 225
$ 49,394,687
$ ( 52,067,693 )
$ - -
$ 827,219
Balance
350,000
$ 3,500,000
- -
$ - -
2,249,290
$ 225
$ 49,394,687
$ ( 52,067,693 )
$ - -
$ 827,219
Proceeds from sale of securities registered direct offering, net of offering costs
-
-
- -
- -
434,784
43
914,185
-
- -
914,228
Stock options issued to settle accrued payable
-
-
- -
- -
-
-
27,500
-
- -
27,500
Stock-based compensation
-
-
- -
- -
-
-
99,738
-
- -
99,738
Net loss
-
-
- -
- -
-
-
-
( 709,555 )
-
( 709,555 )
Balance, March 31, 2025
350,000
$ 3,500,000
$ -
$ -
2,684,074
$ 268
$ 50,436,110
$ ( 52,777,248 )
$ -
$ 1,159,130
Balance
350,000
$ 3,500,000
$ -
$ -
2,684,074
$ 268
$ 50,436,110
$ ( 52,777,248 )
$ -
$ 1,159,130
See
accompanying notes to condensed consolidated financial statements.
5
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2026
2025
Three Months Ended March 31,
2026
2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 1,987,608 )
$ ( 709,555 )
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash operating lease cost
122,553
-
Stock-based compensation expense
82,176
99,738
Fair value of shares issued for services
53,400
-
Changes in operating assets and liabilities:
Prepaid insurance
( 29,349 )
3,813
Other prepaid expenses
( 56,244 )
( 26,793 )
Accounts payable and accrued expenses
( 45,401 )
56,770
Research and development contract liabilities
6,297
7,544
Operating lease liability
22,813
-
Net cash used in operating activities
( 1,831,363 )
( 568,483 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Capitalized costs for LiGHT equipment
( 24,859 )
-
Net cash used in investing activities
( 24,859 )
-
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of securities in registered direct offerings, net of offering costs
-
914,228
Net cash provided by financing activities
-
914,228
NET CHANGE IN CASH
Net increase (decrease)
( 1,856,222 )
345,745
Cash - Beginning of period
5,106,872
1,038,952
Cash - End of period
$ 3,250,650
$ 1,384,697
Supplemental disclosures of cash flow information:
Cash paid for interest
$ -
$ 3,135
Non-cash investing and financing activities:
Settlement of accrued compensation to Board of Directors by issuance of stock options
-
$ 27,500
Exercise of pre-funded warrants
$ 28
$ -
Conversion of Series B Convertible Preferred Stock into common stock and related dividend
$ 1,800,642
$ -
See
accompanying notes to condensed consolidated financial statements.
6
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Three
Months Ended March 31, 2026 and 2025
1.
Organization and Basis of Presentation
The
unaudited condensed consolidated financial statements as of March 31, 2026, and for the three months ended March 31, 2026 and 2025,
of Lixte Biotechnology Holdings, Inc. (a Delaware corporation), include the accounts of Lixte Biotechnology, Inc. (a wholly-owned Delaware corporation), and Liora Technologies Europe Ltd. (“Liora”, an 80% owned corporation
organized under the laws of England and Wales) (collectively,
the “Company”).
In the opinion of
management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly
the financial position of the Company as of March 31, 2026, and the results of its operations for the three months ended March 31,
2026, and its cash flows for the three months ended March 31, 2026. Operating results for the interim periods presented are not
necessarily indicative of the results to be expected for a full fiscal year. The condensed consolidated balance sheet at December
31, 2025 has been derived from the Company’s audited consolidated financial statements at such date.
The
condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities
and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations.
These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included
in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC.
Business
The
Company is a clinical-stage biopharmaceutical and proton cancer therapy company focused on identifying new targets for cancer drug development
and developing and commercializing cancer therapies. The Company’s drug product pipeline is primarily focused on inhibitors of
protein phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies.
The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The
Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown
to have clinical anti-cancer activity.
The
Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled
proton therapy systems for treating tumors in various types of cancers. Liora’s proprietary technology, known as LiGHT System (Linac
for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy.
Liora is an excellent complement to the pharmaceutical side of the Company’s business and ongoing clinical trials with LB-100 for
Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer.
The
Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company
has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation
for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its
operating requirements.
7
Going
Concern
For
the three months ended March 31, 2026, the Company incurred a net loss of $ 1,987,608
and used cash in operations of $ 1,831,363 .
As of March 31, 2026, the Company had cash of $ 3,250,650 available
to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows
as it advances its development programs. As a result, management has concluded that there is a substantial doubt regarding the Company’s
ability to continue as a going concern for a period of at least 12 months beyond the filing of this quarterly report. In addition, our
independent registered public accounting firm, in their audit report to the financial statements included in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2025, expressed substantial doubt about the Company’s ability to continue as
a going concern. The condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern
and do not include any adjustments that might result from the outcome of this uncertainty.
The
Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial
research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues
for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements
and clinical trial monitoring agreements aggregated approximately $ 483,000 which are expected to be incurred through December 31, 2027.
In
addition, the Company expects to incur approximately $ 2 million over the next 24 months to recommission
and update the LiGHT system equipment. Liora currently has no revenues, and the Company will require additional capital to fund these activities.
Management
is actively evaluating and pursuing additional financing alternatives, including equity and debt financings and potential strategic transactions.
However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If
the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development
programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the
cessation of operations.
Nasdaq
Compliance
The
Company’s common stock is traded on the Nasdaq Capital Market under the symbol “LIXT”.
On
August 23, 2024, the Company received written notification from the Listing Qualifications Department (the “Staff”) of the
Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the minimum stockholders’ equity requirement
of $ 2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”).
On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement. On
October 21, 2024, the Staff provided written notification to the Company that it had granted an extension through February 18, 2025 to
regain compliance with the Stockholders’ Equity Requirement. As of February 18, 2025, the Company had not gained compliance with
the Stockholders’ Equity Requirement. Accordingly, on February 19, 2025, the Company received written notification from the Staff
stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain
compliance. The Company timely requested a hearing before the Nasdaq Hearings Panel (“Panel”), staying any suspension or
delisting pending the Panel’s decision. Following an April 3, 2025 hearing, the Panel granted the Company a further extension through
July 3, 2025 to regain compliance. On July 2, 2025, the Company closed a $ 5.05 million private placement and, on July 8, 2025, completed
a $ 1.5 million registered direct offering. On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’
equity requirement.
The
Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During this period, any future
deficiency in stockholders’ equity would require the Company to request a hearing before the Panel rather than submit a new compliance
plan.
8
2.
Summary of Significant Accounting Policies
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation
of accruals for clinical trial costs and other potential liabilities, and valuing equity instruments issued for services.
Asset
Acquisitions
The
Company assesses whether an acquisition is a business combination or an asset acquisition. If substantially all of the gross assets acquired
are concentrated in a single asset or group of similar assets, then the acquisition is accounted for as an asset acquisition, where the
purchase consideration is allocated on a relative fair value basis to the assets acquired. An asset acquisition does not result in the
recognition of goodwill and transaction costs are capitalized as part of the cost of the asset or group of assets acquired. The Company
uses its best estimates and assumptions to assign fair value to the tangible and intangible assets acquired and liabilities assumed at
the acquisition date. The acquisitions costs are allocated to the assets acquired on a relative fair value basis.
Property
and Equipment
The
Company property and equipment consists of Liora’s LiGHT system equipment. Property and equipment are recorded at cost. The LiGHT machine
requires recommissioning and updates and is not yet ready for its intended use. Accordingly, it is treated as an asset under construction,
and depreciation will not begin until the asset is placed into service.
Long
– Lived Assets
Long-lived
assets, which include property, plant and equipment and operating lease right-of-use assets, are reviewed for impairment whenever events
or changes in circumstances indicate the carrying amount of an asset may not be recoverable.
Recoverability
of long-lived assets to be held and used is measured by comparing the carrying amount of an asset to the estimated undiscounted future
cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows,
an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the assets. Fair
value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable.
9
The
Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the asset’s carrying
amount may not be recoverable. In conducting its long-lived asset impairment analyses, the Company groups assets and liabilities at the
lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities and evaluates
the asset group against the sum of the undiscounted future cash flows. If the undiscounted cash flows do not indicate the carrying amount
of the asset is recoverable, an impairment charge is measured as the amount by which the carrying amount of the asset group asset group
exceeds its fair value based on discounted cash flow analysis or appraisals. There was no impairment of long-lived assets for the three
months ended March 31, 2026 and 2025.
Research
and Development
Research
and development costs are charged to expense as incurred. The costs of equipment that are acquired or constructed for research and development
activities, and have alternative future uses, are classified as property and equipment and depreciated over their estimated useful lives.
Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,
design, development, conduct and management of clinical trials with respect to the Company’s clinical compound and product candidate.
Research and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged
to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States
and in the European Union in accordance with the laws and regulations of such jurisdictions.
Research
and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of
milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing
schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are
charged to operations as incurred.
Obligations
incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research
and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified
in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions
are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded
as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the
Company’s consolidated statement of operations.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs
in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Patent, Licensing, Legal and Filing Fees and Costs
Due
to the significant uncertainty associated with the successful development of commercially viable products based on the Company’s
research efforts and related patent applications, all patent, licensing, legal and filing fees and costs related to the development
and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing
fees and costs were $ 35,032 and $ 56,084 for the three months ended March 31, 2026 and 2025, respectively. Patent and licensing legal
and filing fees and costs are included in general and administrative costs in the Company’s consolidated statement of operations.
Concentration
of Risk
The
Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred
for these services can be for a specific period (typically one year) or for a specific project or task. Costs and expenses incurred that
represented 10 % or more of general and administrative costs or research and development costs for the three months ended March 31, 2026
and 2025 are described below.
General
and administrative costs for the three months ended March 31, 2026 and 2025 include charges from legal firms and other vendors for general
licensing and patent prosecution costs relating to the Company’s intellectual properties representing 2.7 % and 9.1 %, respectively
of total general and administrative costs. General and administrative costs for the three months ended March 31, 2026 also include charges
for management representation representing 7.29 % of total general and administrative costs. General and administrative costs for the
three months ended March 31, 2026 includes charge from a vendor and consultant of 20 % and 30 % respectively, of total general and administrative
costs. General and administrative costs for the three months ended March 31, 2026 and 2025 include charges for the fair value of stock
options granted to directors and corporate officers representing 0 % and 12.1 %, respectively, of total general and administrative costs.
Research
and development costs for the three months ended March 31, 2026 include charges from two major vendors representing 90.6 % , of total
research and development costs.
Research
and development costs for the three months ended March 31, 2025 include charges from five vendors and consultants representing 30.7 %,
17.1 %, 15.3 %, 15.1 % and 14.7 %, respectively, of total research and development costs.
10
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for services
rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally
time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.
The
Company accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of services
received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense
on the straight-line basis in the Company’s financial statements over the vesting period of the awards. Recognition of compensation
expense for non-employees is in the same period and manner as if the Company had paid cash for the services.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is
affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock
option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.
Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between
the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical
volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of
the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on
the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.
The
Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development
costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to
satisfy stock option exercises.
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the
warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC
815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial
instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the
requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common
stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the
Company’s control, among other conditions for equity classification. The Company has determined that the warrants issued in
the February 2025 equity financing, and the July 2025 equity financings (see Note 5) meet the requirements for equity
classification. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required
to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not
meet all of the criteria for equity classification, the warrants are required to be liability-classified and recorded at their
initial fair value on the date of issuance and remeasured at fair value at each reporting date. At March 31, 2026 and December 31,
2025, the Company did not have any liability-classified warrants.
Segment
Information
The
Company’s Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performance
and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Because
the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable
segment, which consists of the development of cancer treatments. The CODM uses consolidated net income (loss) as the sole measure of
segment profit or loss.
11
Earnings
(Loss) Per Share
The
Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as
the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted
EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,
warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if
later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share)
are excluded from the calculation of diluted EPS.
Loss
per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods.
The weighted average number of common shares outstanding utilized for determining basic net loss per common share for the three months
ended March 31, 2026 includes all pre-funded warrants sold that have not been exercised as of March 31, 2026. Basic and diluted loss
per common share was the same for all periods presented because all preferred shares, warrants (excluding pre-funded warrants) and stock
options outstanding were anti-dilutive.
At
March 31, 2026 and 2025, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire
shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
2026
2025
March 31,
2026
2025
Series A Convertible Preferred Stock
-
72,917
Common stock warrants (excluding pre-funded warrants)
8,501,283
1,275,758
Common stock options
1,148,059
662,078
Total
9,649,342
2,010,753
Foreign
Currency Translation
The
consolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.
The
Company periodically incurs a cost or expense in a foreign jurisdiction denominated in a local currency. The Company purchases the required
foreign currency to pay such cost or expense on an as-needed basis. Such cost or expense is converted into United States dollars for
financial statement purposes based on the foreign currency conversion rate in effect on the transaction date. The Company purchases the
requisite foreign currency to pay such cost or expense on an as-needed basis. Any gain or loss resulting from the purchase of the foreign
currency is included as realized foreign currency gain (loss) in the consolidated statement of operations.
During
the three months ended March 31, 2026 and 2025, the Company incurred various costs and expenses denominated in Euros, which were converted
into United States dollars at the average rate of 1.1703 and 1.0516 Euros per United States dollar, respectively. As of March 31, 2026
and December 31, 2025, the Company did not hold any currencies other than the United States dollar in its bank accounts, and was not
a party to any foreign currency forward or exchange contracts.
12
Fair
Value of Financial Instruments
The
authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed
in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair
value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to
access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable
through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,
non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop
its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives
and commingled investment funds and are measured using present value pricing models.
The
Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the
lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company
performs an analysis of the assets and liabilities at each reporting period end.
The
carrying value of financial instruments, which consists of accounts payable and accrued expenses, is considered to be representative
of their respective fair values due to the short-term nature of those instruments. The carrying value of digital assets is based on quoted
prices in active markets (Level 1 inputs).
Recent
Accounting Pronouncements
In November 2024, the Financial
Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2024-03 “Income Statement
– Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement
Expenses.” This ASU requires public business entities to disclose, for interim and annual reporting periods, additional information
about certain income statement expense categories. The requirements are effective for fiscal years beginning after December 15, 2026,
and for interim periods beginning after December 15, 2027. Entities are permitted to apply either the prospective or retrospective transition
methods. The Company is in the process of evaluating the adoption of this ASU to determine its impact on the Company’s disclosures.
In December 2025, the FASB issued
ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which includes amendments to clarify interim reporting requirements
and applicability of Topic 270 and codifies a principle requiring disclosure of material events and changes since the most recent annual
reporting period. This guidance is effective for the Company for interim periods within fiscal years beginning after December 15, 2027,
with early adoption permitted. The Company is in the process of evaluating the impact of adoption of this ASU on its Condensed Consolidated
Financial Statements.
13
The Company’s management
has evaluated all other recently issued, but not yet effective, accounting standards and guidance that have been issued or proposed by
the FASB or other standards-setting bodies through the filing date of these financial statements and does not believe the future adoption
of any such pronouncements will have a material effect on the Company’s financial position and results of operations.
3.
Segment Information
The
Company’s chief operating decision maker (“CODM”) has been identified as the Company’s Chief Executive Officer
(“CEO”). The Company’s CODM evaluates performance and makes operating decisions about allocating resources based on
financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company
has determined that it currently has a single 1 operating segment which is comprised of the consolidated financial results of the Company.
The following table presents the
significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’s CODM and included in research
and development costs for the three months and March 31, 2026 and 2025.
Schedule
of Information by Segment
2026
2025
Three Months Ended
March 31,
2026
2025
Clinical and related oversight costs
$ 309,794
$ 15,868
Preclinical research focused on development of additional novel anti-cancer compounds
23,582
42,770
Regulatory service costs
-
32,819
Total research and development costs
$ 333,376
$ 91,457
14
The
following table presents a summary of research and development costs for the three months ended March 31, 2026 and 2025 based on the
respective geographical regions where such costs were incurred.
2026
2025
Three Months Ended
March 31,
2026
2025
United States
$ 38,972
$ 58,571
Spain
294,404
32,886
Total
$ 333,376
$ 91,457
The
following table presents the significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’s
CODM and included in general and administrative costs for the three months ended March 31, 2026 and 2025.
2026
2025
Three Months Ended
March 31,
2026
2025
Compensation:
Cash based compensation
$
213,434
$
108,731
Stock-based compensation
82,176
99,738
Patent and licensing legal and filing fees and costs
35,032
56,084
Marketing and public relations
481,900
-
Accounting and bookkepping services
254,744
41,909
Audit and legal
195,846
134,103
Consulting fees
181,856
29,303
Insurance expense
64,387
64,277
Other costs and expenses, net
144,656
81,338
Total general and administrative costs
$ 1,654,031
$ 615,483
4.
Acquisition of Liora Technologies Europe Ltd.
On
November 21, 2025, the Company entered into a share exchange agreement to acquire Liora from Orbit Capital. The acquisition was
executed through multiple agreements, including (i) an initial share exchange agreement dated November 21, 2025 (the “Original
SEA”); (ii) a subsequent share exchange agreement dated December 30, 2025 (the “Post-Closing SEA”); and (iii) an
amended and restated agreement dated March 6, 2026 (the “A&R Agreement”). The Post-Closing SEA finalized the
structure such that Lixte owned 80 %
of Liora and Orbit Capital owned 20 %
of Liora. In addition there was a royalty agreement between the Company and Orbit dated November 21, 2025, that was terminated on
December 16, 2025. As of March 31, 2026 and December 31, 2025, the Company owns 80 %
of Liora and consolidates Liora, with the remaining 20 %
ownership interest presented as noncontrolling interest.
15
The
Company evaluated whether the acquisition met the definition of a business. Management determined that substantially all of the fair
value of the assets acquired is concentrated in the LiGHT proton therapy system equipment, and that the acquisition of Liora did not
include substantive processes or an organized workforce. Accordingly, the acquisition does not meet the definition of a business and
is accounted for as an asset acquisition.
The
following table summarizes the fair value of the purchase consideration and the fair value of tangible assets and assumed liabilities
of Liora on the date of acquisition:
Summarizes The Fair Value of Purchase Consideration
Total consideration transferred and implied fair value of acquired assets
Cash
$ 440,000
Digital assets (10.5925 Bitcoin BTC)
901,323
Digital assets (300.699 Ether ETH)
831,643
Common stock (700,000 shares of common stock at $ 4.31 per share)
3,017,000
Total consideration transferred for 80 % interest
5,189,966
Noncontrolling interest ( 20 %)
1,297,492
The implied total value of the acquired asset ( 100 %)
6,487,458
Capitalized transaction costs
95,102
Total acquisition costs
$ 6,582,560
Liora’s identifiable assets acquired and liabilities assumed
LIGHT proton therapy system equipment
$ 6,582,560
In January 2026, the Company capitalized an additional
$ 24,859 of direct acquisition costs consisting primarily of UK stamp duty fees, increasing the recorded cost basis of the acquired LIGHT
proton therapy system equipment to $ 6,607,419 .
The
LiGHT system is presented as a consolidated asset. The 20 % ownership retained by Orbit is presented as noncontrolling interest in equity.
The LiGHT system is a tangible long-lived asset. The LIGHT system is currently not operational and requires recommissioning, upgrades,
and regulatory clearance. Accordingly, the asset is classified as property and equipment and treated as an asset under construction until
it is ready for its intended use.
Contingent
consideration
Liora’s
purchase of the LiGHT system from AVO included deferred milestone-based payments of $ 5 million, which Lixte assumed with the purchase
of the LiGHT system. The deferred consideration is contingent upon specified future milestones. As of December 31, 2025, no amounts have
been recognized related to these contingent payments. Accordingly, the deferred consideration should be evaluated under the applicable
contingency guidance and recognized when the recognition threshold is met. Until that time, the deferred contingent amounts should be
disclosed, as appropriate, but not recorded as part of the initial purchase price allocation.
Lease
accounting
The
LiGHT machine is located in a leased facility. After the acquisition of the LiGHT machine from AVO, Liora entered into a two year operating
lease with the Daresbury Laboratory site on November 17, 2025. The Company assumed the lease obligations and is accounting for the lease
under ASC 842, including recognition of a right-of-use asset and lease liability (see Note 5). Currently, the Company expects that the
LiGHT machine will continue to be housed at this location on a long-term basis.
16
5. Leases
On November 21, 2025, the Company assumed, as part
of the Liora acquisition, a two-year lease agreement with United Kingdom Research and Innovation for the rental of the premises at UKRI
Daresbury that houses the acquired LiGHT system equipment. The lease was classified as an operating lease and has a quarterly base rent
of GBP 147,596 or approximately $ 198,500 . The lease commencement date was November 17, 2025 and has no renewal option. The Company recognized
a right-of-use asset and corresponding lease liability of $ 1,043,437 for the UKRI Daresbury Lease.
Supplemental cash flow information related to operating
leases is as follows:
Schedule
of Supplemental Cash Flow Information Related to Operating Leases
Three months ended
March 31, 2026
Cash payments for operating leases
-
Weighted-average remaining lease term (in years)
1.63
Weighted-average discount rate
9.0 %
The Company’s operating lease right of use asset
was $ 972,682 as of December 31, 2025. During the three months ended March 31, 2026, the Company recorded noncash operating lease expense
of $ 122,553 , resulting in an operating lease right of use asset of $ 850,129 as of March 31, 2026.
The Company’s operating lease liability balance
was $ 1,034,377 as of December 31, 2025. During the three months ended March 31, 2026, the Company was not required to make any lease payments
against its operating lease obligations. During the three months ended March 31, 2026, the accretion of the lease liability was $ 22,813 ,
resulting in a lease liability of $ 1,057,190 as of March 31, 2026. The current portion of operating lease obligation was $ 595,418 , and
a long-term portion of the operating lease obligation was $ 461,772 .
During the three months ended March 31, 2026 and 2025,
lease costs totaled approximately $ 83,860 and $ 77,061 , respectively.
As of March 31, 2026, the weighted average remaining
lease terms for operating lease is 1.63 years, and the weighted average discount rate for operating lease is 9.00 %.
Maturities of the Company’s operating lease
liabilities are as follows as of March 31, 2026:
Schedule
of Maturities of Operating Lease Liabilities
As of
March 31,
2026
2026 (remaining)
$ 595,418
2027
564,884
Thereafter
-
Total
1,160,302
Less: Imputed interest
( 103,112 )
Total operating lease liability
$ 1,057,190
6.
Stockholders’ Equity
Preferred
Stock
The
Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $ 0.0001 per share. On March 17, 2015, the Company
filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware
Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as
Series A Convertible Preferred Stock, which are non-voting.
On
October 21, 2025, the Company filed a Certificate of Elimination of Certificate of Designations of Series A Convertible Preferred Stock
with the Delaware Secretary of State to eliminate the 350,000 shares of Preferred Stock associated with the Series A Convertible Preferred
Stock classification.
17
On
July 1, 2025, the Company filed amendment to Certificate of Incorporation by filing Certificate of Designations, Preferences, Rights
and Limitations of its Series B Convertible Preferred Stock with the Delaware Secretary of State. The Company has designated a total
of 3,573,130 shares as Series B Convertible Preferred Stock with a stated value of $ 0.7146 per share. Each Preferred Share is convertible
into one share of Common Stock, subject to standard adjustments such as stock splits and stock dividends. The Preferred Shares are non-voting,
except that certain actions of the Company may not be taken except upon approval of holders who own a majority in stated value of the
Preferred Shares. The Preferred Shares bear an 8 % per annum cumulative dividend non-compounding and payable at conversion either in cash
or, at the holder’s election, in shares of Common Stock valued at the then effective conversion rate.
As
of March 31, 2026 and December 31, 2025 the Company had 10,000,000 and 7,576,870
shares respectively, of undesignated preferred stock, which may be issued with such rights and powers as the Board of Directors may
designate.
Common
Stock
The
Company is authorized to issue a total of 100,000,000 shares of common stock, par value $ 0.0001 per share. As of March 31, 2026 and December
31, 2025, the Company had 11,632,944 shares and 8,790,102 shares, respectively, of common stock issued and outstanding.
2026 common stock transactions
Shares issued for services
On January 6, 2026, the Company
entered into a consulting agreement with Pillow Hog Ventures, Inc (“PHVC”) for marketing and strategic consulting services.
The agreement is for a term of six months ending June 30, 2026. The agreement provides for the payment to PHVC of 15,000 shares of the
Company’s common stock.
Exercise of Preferred Series B Stock
During January and February 2026, holders of the Company’s Preferred Series B stock converted an aggregate
of 2,423,130 preferred shares, together with accrued cumulative dividends of $ 86,955 , into 2,544,821 shares of the Company’s common
stock. Each preferred share was convertible into one share of common stock, with accrued 8% cumulative dividends payable upon conversion
in additional shares of common stock at a conversion price of $ 0.7146 per share. As of March 31, 2026, no Preferred Series B shares remained
outstanding.
Exercise of Pre-Funded Warrants
During the three months ended
March 31, 2026, warrant holders exercised 283,021 pre-funded warrants resulting in the issuance of 283,021 shares of the Company’s
common stock.
2025 common stock transactions
February
2025 equity offering
Effective
February 13, 2025, the Company closed a registered direct offering with certain investors which resulted in gross proceeds of $ 1,050,003 .
After deducting placement agent fees and direct offering expenses of $ 135,775 , the Company received net proceeds of $ 914,228 . The Company
sold and issued 434,784 shares of common stock at $ 2.415 per share. In a concurrent private placement, the Company also issued warrants
to purchase 434,784 shares of common stock at an exercise price of $ 2.29 per share, exercisable immediately and expire five years from
the date of issuance. The Company also granted the placement agent warrants to purchase 32,609 shares of common stock at $ 3.0188 per
share, expiring February 11, 2030 .
All
warrants issued in the February 2025 equity offering include customary anti-dilution adjustments and a “fundamental transaction”
provision. If a qualifying fundamental transaction within the Company’s control is consummated, holders may elect cash settlement
equal to the Black-Scholes value. For fundamental transactions outside the Company’s control, holders are entitled to receive the
same consideration as common shareholders. The warrants are classified in permanent equity. Any future cash settlements will be accounted
for as equity distributions upon occurrence of the related fundamental transaction.
18
Common
Stock Warrants
A
summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s
public offerings, but excluding pre-funded warrants, is presented below.
Schedule
of Warrants Outstanding
Number of Shares
Weighted Average Exercise Price
Weighted Average Remaining Contractual Life (in Years)
Warrants outstanding at December 31, 2025
8,512,614
1.914
Issued
-
Exercised
-
Expired
( 11,331 )
Warrants outstanding at March 31, 2026
8,501,283
1.8677
3.56
At
March 31, 2026, the outstanding warrants are exercisable at the following prices per common share:
Schedule
of Warrants Outstanding and Exercisable
Exercise Price
Warrants Outstanding (Shares)
$ 1.00
6,355,214
2.29
414,784
3.0188
32,609
6,802,607
During
the periods presented, the Company issued pre-funded warrants, each of which is exercisable immediately upon issuance at a de minimis
exercise price of $ 0.00001 per share. Because the holders have already paid substantially all of the purchase price at issuance and the
remaining exercise price is nominal, the pre-funded warrants are economically equivalent to outstanding common shares. The pre-funded
warrants meet the criteria for equity classification. The warrants are indexed to the Company’s own stock, require physical settlement
in shares, and do not include features that could require cash settlement.
Due
to their economic characteristics, pre-funded warrants function as share-like instruments, rather than traditional warrants with a substantive
exercise price or term. Therefore, including them together with standard warrants in the warrant rollforward would significantly distort
both the weighted-average exercise price and the weighted-average remaining contractual life, rendering those disclosures not meaningful.
As a result, the Company presents pre-funded warrants separately from standard common stock warrants in the tables below. The pre-funded
warrants are excluded from weighted-average exercise price and remaining life due to their de-minimis strike price and share-like characteristics.
The
following table presents a summary of activities related to pre-funded warrants.
Summary of Activities Related to Common Stock Warrants
Number of Shares
Pre-funded warrants outstanding at December 31, 2025
545,521
Issued
-
Exercised
( 283,021 )
Expired
-
Pre-funded warrants outstanding at March 31, 2026
262,500
The
following table presents a summary of total number of common stock warrants and pre-funded warrants.
Schedule
of Common Stock Warrants and Pre-Funded Warrant
Warrant Type
3/31/2026
Common stock warrants
8,501,283
Pre-funded warrants
262,500
Total warrants outstanding
8,763,783
19
7.
Related Party Transactions
Related
party transactions include transactions with the Company’s officers, directors and affiliates.
Employment
Agreements with Officers
Effective
June 16, 2025, the Company entered into an employment agreement with Geordan Pursglove pursuant to which Mr. Pursglove was appointed
as the Company’s Chief Executive Officer and Chairman of the Board of Directors for a term of three years, subject to automatic
termination if the Company did not complete a successful financing that would enable it to maintain its listing on the Nasdaq Capital
Market by July 3, 2025, which was accomplished on July 2, 2025. Under the employment agreement, Mr. Pursglove will receive an annual
salary of $ 240,000 , which was increased to $ 360,000 effective as of January 1, 2026. During the three months ended March 31, 2026 and
2025, the Company paid $ 90,000 and $ 0 , respectively to Mr. Pursglove. Effective September 1, 2025, the Company appointed Geordan
Pursglove as the Company’s President as the result of the resignation of Bastiaan (“Bas”) van der Baan (see below).
Effective
September 1, 2025, the Company entered into an employment agreement with Peter Stazzone to act as the Company’s Chief Financial
Officer, for a term of one year, with an annual salary of $ 150,000 . During the three months ended March 31, 2026, the Company paid $ 37,500
to Mr. Stazzone.
In
2023, the Company entered into an employment agreement with Bas van der Baan to act as the Company’s President, Chief Executive
Officer. Effective October 6, 2023, Mr. van der Baan was appointed as Chairman of the Board of Directors. Effective June 16, 2025, the
employment agreement was amended to provide that Mr. van der Baan will serve as President and Chief Scientific Officer of the Company.
Effective September 1, 2025, Mr. van der Bann resigned as President, but remained as the Company’s Chief Scientific Officer. The
term of the employment agreement is for three years and is automatically renewable for additional one-year periods. During the three
months ended March 31, 2026 and 2025, the Company paid $ 40,987 and $ 37,477 , respectively, respectively, to Mr. van der Baan.
Former
officers
In
2020, the Company entered into an employment agreement with Robert N. Weingarten to act as the Company’s Vice President and Chief
Financial Officer. Mr. Weingarten resigned from the Company on September 1, 2025. During the three months ended March 31, 2025, the Company
paid $ 43,750 to Mr. Weingarten.
In
2024, the Company entered into a consulting agreement with Dr. Jan H.M. Schellens, M.D., Ph.D. the Company engaged Dr. Schellens as a
consultant, and, effective August 1, 2024, as the Company’s Chief Medical Officer. The Company pays Dr. Schellens an annual compensation
of 104,000 Euros (approximately $ 108,000 as of December 31, 2025). Effective as of July 31, 2025, the Company agreed to accept the resignation
of Dr. Schellens. During the three months ended March 31, 2025, the Company paid $ 27,504 to Dr. Schellens.
In
2022, René Bernards was appointed to the Company’s Board of Directors as an independent director. and would receive annual
compensation for his services on the Board only in the form of cash, in lieu of the annual June 30 grant of stock options as provided
to the Company’s other non-officer directors. During the three months ended March 31, 2025, the Company recorded charges of $ 0 .
On September 1, 2025 the board accepted his resignation.
Compensatory
Arrangements for Members of the Board of Directors
Total
cash compensation paid to non-officer directors was $ 27,500 and $ 0 , respectively, for the three months ended March 31, 2026 and 2025.
Stock-based
compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 8.
20
8.
Stock-Based Compensation
The
Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services
of employees, contractors, and consultants of the Company.
Stock
Options Issued, Vested and Cancelled
The
Company periodically issues stock options as incentive compensation to directors and as compensation for the services of employees, contractors,
and consultants of the Company.
As of March 31, 2026, unexpired stock options for 719,309 shares were issued and outstanding under the 2020 Plan and 2,780,691 shares were
available for issuance under the 2020 Plan.
During
the three months ended March 31, 2026, the Company did not grant any stock options.
On
January 20, 2025, the Company granted 16,554 stock options to four non-officer directors of the Company to purchase shares of the Company’s
common stock, exercisable for a period of five years at an exercise price of $ 2.33 per share (the closing market price on the grant date).
The grant date fair value of the stock options determined pursuant to the Black-Scholes option-pricing model was determined to be $ 27,500
and was accrued at December 31, 2024 and charged to operations in 2024. During the three months ended March 31, 2025, there was no expense
charged to operations with respect to these stock options.
On
March 31, 2025, the Company granted to four non-officer directors of the Company a total of 32,181 stock options to purchase shares of
the Company’s common stock, exercisable for a period of five years at an exercise price of $ 1.21 per share (the closing market
price on the grant date). The stock options are exercisable for a period of five years and were immediately vested. The grant date fair
value of the stock options determined pursuant to the Black-Scholes option-pricing model was determined to be $ 27,500 , which was charged
to operations on March 31, 2025, the date the stock options were fully vested.
The
total fair value of options that vested during the three months ended March 31, 2026 and 2025, was $ 82,176
and $ 99,738
respectively.
The
fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest
rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the
Company’s expectation of dividend payouts and is assumed to be zero. The estimated volatility is based on the historical volatility
of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock
option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as
the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the
common stock is determined by reference to the quoted market price of the common stock on the grant date.
For
stock options requiring an assessment of value during the three months ended March 31, 2025, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Schedule
of Fair Value of Each Option Award Estimated Assumption
Risk-free
interest rate
3.950
%
Expected
dividend yield
0
%
Expected
volatility
128.78
%
Expected
life
2.5
years
21
A
summary of stock-based compensation costs for the three months ended March 31, 2026 and 2025 is as follows:
Schedule
of Stock-based Compensation Costs
2026
2025
Three Months Ended March 31,
2026
2025
Officers and directors of the Company
$ 82,176
$ 99,738
Non-related parties
-
-
Stock-based compensation costs
$ 82,176
$ 99,738
A
summary of stock option activity during the three months ended March 31, 2026 is as
follows:
Schedule
of Stock Option Activity Including Options Form of Warrants
Number of Shares
Weighted Average
Exercise Price
Weighted Average Remaining Contractual
Life (in Years)
Stock options outstanding at December 31, 2025
1,158,059
$ 5.033
3.34
Granted
—
—
Exercised
—
—
Expired
( 10,000 )
32.10
Stock options outstanding at March 31, 2026
1,148,059
4.797
3.13
Stock options exercisable at December 31, 2025
1,059,311
5.20
3.23
Stock options exercisable at March 31, 2026
1,148,059
$ 4.797
3.13
As
of March 31, 2026, 1,148,059 stock options were vested and exercisable. Total deferred compensation expense for the outstanding value
of unvested stock options was approximately $ 230,000 at March 31, 2026, which will be recognized subsequent to March 31, 2026 over a
weighted-average period of approximately 9 months.
At
March 31, 2026, the outstanding common stock options, including options issued in the form of warrants, are exercisable at the following
prices per common share:
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants
Exercise
Prices
Options
Outstanding
(Shares)
Options
Exercisable
(Shares)
$
0.905
72,648
50,148
$
1.210
32,181
32,181
$
1.870
21,217
21,217
$
1.950
250,000
250,000
$
2.330
16,665
16,665
$
2.370
51,598
44,100
$
2.390
5,000
5,000
$
2.830
350,000
350,000
$
3.590
50,000
31,250
$
4.050
50,000
25,000
$
4.450
50,000
25,000
$
5.025
8,750
8,750
$
5.880
40,000
40,000
$
7.400
55,000
55,000
$
20.000
20,000
20,000
$
20.600
20,000
20,000
$
28.000
25,000
25,000
$
30.300
30,000
30,000
$
32.100
-
10,000
1,148,059
1,059,311
Based
on the closing fair market value of $ 3.07 per common share on March 31, 2026, the intrinsic value attributed to exercisable but unexercised
common stock options was approximately $ 615,232 at March 31, 2026.
Outstanding
stock options to acquire 66,249 shares of the Company’s common stock had not vested at March 31, 2026.
22
9.
Commitments and Contingencies
Legal
Claims
The
Company may be subject to legal claims and actions from time to time as part of its business activities. As of March 31, 2026 and
December 31, 2025, the Company was not subject to any threatened or pending lawsuits, legal claims or legal proceedings.
Principal
Commitments
Clinical
Trial Agreements
At
March 31, 2026, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial
monitoring agreements not yet incurred, as described below, aggregated $ 482,702 , including clinical trial agreements of $ 293,000 and clinical
trial monitoring agreements of $ 189,702 , which, based on current estimates, are currently scheduled to be incurred through approximately
December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability
of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s
current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such
clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced.
Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series
of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated,
in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached.
Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions
and conditions and are typically subject to significant modifications and revisions over time.
The
following is a summary of the Company’s ongoing active contractual clinical trials described below as of March 31, 2026:
Schedule
of Contractual Clinical Trials
Description of Clinical Trial
Institution
Start Date
Projected End Date
Number of Patients in Trial
Study Objective
Clinical Update
Expected Date of Preliminary Efficacy Signal
NCT No.
Remaining Financial Contractual Commitment
LB-100 combined with atezolizumab in microsatellite stable metastatic colorectal cancer (Phase 1b)
Netherlands Cancer Institute (NKI)
August 2024
December 2026
37
Determine RP2D with atezolizumab
First patient entered August 2024, in total two patients entered
December 2027
NCT06012734
- (1
)
LB-100 combined with doxorubicin in advanced soft tissue sarcoma (Phase 1b)
GEIS
June 2023
Enrollment completed September 2024
9 to 18
Determine MTD and RP2D
Fourteen patients
entered
March 2026
NCT05809830
$
293,000
Doxorubicin with or without LB-100 in advanced soft tissue sarcoma (Randomized Phase 2)
GEIS
TBD
TBD
150
Determine efficacy: PFS
Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial)
TBD
NCT05809830
$
- (1
)
LB-100 combined with dostarlimab in ovarian clear cell carcinoma (Phase 1b/2)
MD Anderson
January 2024
December 2027
42
Determine the OS of patients with recurrent ovarian clear cell carcinoma
Twenty one patients entered
December 2027
NCT06065462
- (1
)
Total
$
293,000
(1)
The
Company has no financial contractual commitments associated with these clinical trials at March 31, 2026.
23
Netherlands
Cancer Institute. In June, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute
(“NKI”) to conduct a Phase 1b clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined
with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with microsatellite
stable metastatic colorectal cancer. Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreement
between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation to
and will not provide any reimbursement of clinical trial costs. Pursuant to the agreement and the protocol set forth in the agreement,
the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and
NKI will be responsible for the recruitment of patients. The agreement provides for the protection of the respective intellectual property
rights of each of the Company, NKI and Roche.
This
Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment
of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can
enhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness
of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals
in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic
colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.
This
study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended
Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate
the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical
trial opened in August 2024 with the enrollment of the first patient. A total of two patients have been enrolled to date. Patient accrual
is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
The
principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious
Adverse Events (“SAEs”) observed in the clinical trial. The Investigational Review Board (IRB) of NKI has requested additional
information with respect to these SAEs and the study has been paused for enrollment until the IRB’s questions have been satisfactorily
addressed (see “Specific Risks Associated with the Company’s Business Activities - Serious Adverse Events” below for
additional information).
The
Company has no financial contractual commitment associated with this clinical trial.
GEIS.
Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the
Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a
study entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue
sarcoma”. The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined
with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).
Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little improvement in survival from adding
cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 has consistently enhanced
the anti-tumor activity of doxorubicin without apparent increases in toxicity.
24
GEIS
has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative
studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as
well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over
a period of two to four years. The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommended
Phase 2 dose of the combination of doxorubicin and LB-100. As advanced sarcoma is a very aggressive disease, the design of the Phase
2 portion of the study assumes a median progression-free survival (“PFS”), no evidence of disease progression or death from
any cause, of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate
a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of
the primary endpoint when approximately 50% of the 102 events required for final analysis is reached.
The
Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July
2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,
it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These
standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.
In
order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out
the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included
the synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of the
steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under
GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,
provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal
application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory
authorities for review and approval before being used in a clinical trial.
On
October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos
y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead
clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this
clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31,
2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez
Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b
portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024. The Company expects
to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.
Given
the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability
of capital resources, the Company entered into Amendment No. 1 to the Collaboration Agreement effective March 11, 2025 that relieved
the Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration
Agreement of approximately $ 3,095,000 . As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.
The
Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement.
During the three months ended March 31, 2026 and 2025, the Company did not incur any costs pursuant to this agreement.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 293,000
for the Phase 1b portion of this clinical trial as of March 31, 2026, which is currently scheduled to be incurred through December 31,
2026. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between
the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency
gain or loss, as appropriate, and have not been significant.
25
MD
Anderson Cancer Center Clinical Trial . On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative
clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc
(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma
(“OCCC”). The study objective is to determine the overall survival (“OS”) of patients with OCCC. The clinical
trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at The
University of Texas - MD Anderson Cancer Center. The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial
support for the clinical trial. On January 29, 2024, the Company announced the entry of the first patient into this clinical trial. The
Company currently expects that this clinical trial will be completed by December 31, 2027.
On
February 25, 2025, the Company announced that it has added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern
University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab
to treat ovarian clear cell cancer. Patient recruitment is underway, and the first patient has been dosed.
Clinical
Trial Monitoring Agreements
MD
Anderson Cancer Center Clinical Trial . On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Andersen
investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1
(“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy
in the treatment of ovarian clear cell carcinoma (“OCCC”). On August 19, 2024, the Company signed a work order agreement
with Theradex to monitor the MD Anderson clinical trial. The study oversight is expected to be completed by January 31, 2027.
Costs
under this letter of intent and related work order agreement are estimated to be approximately $ 95,000 . During the three months ended
March 31, 2026 and 2025, the Company incurred costs of $ 7,742 and $ 6,638 pursuant to this letter of intent and subsequent work order.
The
Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $ 40,000
as of March 31, 2026, which is expected to be incurred through December 31, 2027.
City
of Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated
clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this
work order agreement were estimated to be approximately $ 335,000 . During the three months ended March 31, 2026 and 2025, the Company
did not incur any costs pursuant to this work order. As of December 31, 2025, total costs of $ 89,323 had been incurred pursuant to this
work order agreement. As a result of the closure of the Agreement with City of Hope effective July 8, 2024, the work order was terminated
on July 8, 2024.
GEIS.
On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinical
Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma. The study
oversight is expected to be completed by December 31, 2026.
Costs
under this work order agreement are estimated to be approximately $ 153,000 , with such payments expected to be allocated approximately
72 % to Theradex for services and approximately 28 % for payments for pass-through software costs. During the three months ended March
31, 2026 and 2025, the Company incurred costs of $ 0 and $ 53,327 , respectively, pursuant to this work order.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $ 86,000 as March 31, 2026, which is expected to be incurred through December 31, 2027.
Netherlands
Cancer Institute. On August 27, 2024, the Company finalized a work order agreement with Theradex, to monitor the NKI Phase 1b clinical
trial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colorectal cancer.
The study oversight was expected to be completed by May 31, 2027.
26
Costs
under this work order agreement were estimated to be approximately $ 106,380 , with such payments expected to be allocated approximately
47 % to Theradex for services and approximately 53 % for payments for pass-through software costs. During three months ended March 31 2026
and 2025, the Company incurred total costs of $ 5,900 and $ 5,200 pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $ 64,000 as of March 31, 2026, which was expected to be incurred through May 31, 2027.
Patent
and License Agreements
National
Institute of Health. Effective February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”)
with the National Institute of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”),
each an institute or center of the National Institute of Health (“NIH”). Pursuant to the License Agreement, the Company has
licensed on an exclusive basis the NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement
(“CRADA”) subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer
activity alone, or in combination with standard anti-cancer drugs. The scope of this clinical research extends to checkpoint inhibitors,
immunotherapy, and radiation for the treatment of cancer. The License Agreement is effective, and shall extend, on a licensed product,
licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights
in each such country in the licensed territory, estimated at twenty years, unless sooner terminated.
The
License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive
cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks. Data from the clinical trials will be
the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories. Subject to the
receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval
has been obtained.
The
Company is obligated to pay the NIH an annual royalty of $ 30,000
is due each January 1 and may be credited against any earned royalties due for sales made in that year. During the three months
ended March 31, 2026 and 2025, the Companyt paid NIH $ 30,000 ,
respectively.
The
Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product
and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but
not less than 1%. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first
commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product
or licensed process expires in such country.
The
Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such
benchmark. The License Agreement defines four such benchmarks, which the Company is required to pursue based on “commercially reasonable
efforts” as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, each with a different specified
benchmark payment amount payable within thirty days of achieving such benchmark. The October 1, 2024 benchmark of $ 100,000 was defined
as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product in the licensed fields
of use. The Company had not commenced a Phase 2 clinical study as of June 30, 2025. The total of all such benchmark payments is $ 1,225,000 .
The
Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under
the licensed patents. These reports, due within sixty days following the end of each calendar year, must include updates on research
and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives. If any deviations from
the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may
amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold,
condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend
the time periods of the benchmarks.
27
The
Company is obligated to pay the NIH sublicensing royalties of 5 % on sublicensing revenue received for granting each sublicense within
sixty days of receipt of such sublicensing revenue.
During
the three months ended March 31, 2026 and 2025, the Company incurred costs of $ 7,500 and $ 7,397 , respectively, in connection with its
obligations under the License Agreement. Such costs when incurred have been included in general and administrative costs in the Company’s
consolidated statement of operations.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 1,735,000
as of March 31, 2026, which is expected to be incurred over approximately the next nineteen years.
Other
Significant Agreements and Contracts
BioPharmaWorks.
Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged
BioPharmaWorks to perform certain services for the Company.
The
Company recorded charges to operations pursuant to this Collaboration Agreement of $ 13,200 and $ 14,000 during the three months ended
March 31, 2026 and 2025, respectively, which were included in research and development costs in the consolidated statements of operations.
Netherlands
Cancer Institute . On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer
Institute, Amsterdam (“NKI”) (see Note 5), one of the world’s leading comprehensive cancer centers, and Oncode Institute,
Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently
modified by Amendment No. 1 thereto.
The
Development Collaboration Agreement is a preclinical study intended to identify the most promising drugs to be combined with LB-100,
and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying
the identified combinations. The Company agreed to fund the preclinical study, at an approximate cost of 391,000 Euros and provide a
sufficient supply of LB-100 to conduct the preclinical study.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional
research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added
500,000 Euros to the operating budget being funded by the Company.
28
On
October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment
No. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the trial at a project cost of
100,000 Euros.
During
the three months ended March 31, 2026 and 2025, the Company incurred charges of $ 0 and $ 0 , respectively, with respect to this agreement. The Company’s
aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 116,000 as of March 31,
2026, which is expected to be incurred through October 2026. As the work is being conducted in Europe and is paid for in Euros, final
costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.
MRI
Global. As amended, the Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical
trials in the United States. During the three months ended March 31, 2026 and 2025, the Company incurred costs of $ 6,000 and $ 15,501 ,
respectively, pursuant to this contract.
Specific
Risks Associated with the Company’s Business Activities
Serious
Adverse Events
The
Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of
these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug
candidate or to another company’s drug used in combination in one of the Company’s clinical trials. It is possible that the
SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects,
treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting
toxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only
allowed at lower dose-levels that have previously been found safe.
If
an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S.
Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring
the Company to pause or discontinue further enrollment and dosing in the Company’s clinical trial. It is also possible that the
clinical trial could be terminated. Any of these actions could delay or halt the development of the Company’s drug candidate, increase
development costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval. Additionally, if an SAE
is confirmed to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further
development of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.
The
occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health
institutions, and investors, diminish the Company’s ability to attract clinical trial participants, and damage the Company’s
ability to interest investors and obtain financing in the future. There can be no assurances that the Company will not experience such
SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.
The
principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating
two SAEs observed in the clinical trial that was launched in August 2024. The Institutional Review Board (the “IRB”) of the
Netherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold. The adverse reactions that developed in
the two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and
atezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second
patient. The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea.
The patient with fever and aphasia fully recovered from the adverse events with supportive medication.
Given
the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study
at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information
about the mode of action of the combination of LB-100 and atezolizumab. The principal investigator prepared a response to the IRB detailing
the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicin
is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of
atezolizumab.
The
reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or
in combination with other cancer drugs. Through September 30,2025, the Company has been informed that a total of 86 patients had received
or were receiving experimental treatment with LB-100.
In
May 2025, the Company updated the safety overview of LB-100 and delivered the updated version 5.0 of the Investigator’s Brochure
(the “IB”), which contains all of the relevant preclinical, clinical and pharmacologic data with respect to the study of
the LB-100 clinical compound in humans, to the investigators of all ongoing clinical trials. The investigators of the study in colorectal
cancer (NCT06012734) submitted a detailed response to the IRB, including the updated IB. The Company is currently awaiting the outcome
of the IRB review.
29
Other
Business Risks
The
Company is also subject to additional risks and uncertainties arising from changes to the macroeconomic environment and geopolitical
events. U.S. and global financial markets have experienced volatility and disruption due to macroeconomic and geopolitical events such
as the implementation of tariffs, inflation, the risk of a recession and ongoing conflicts in other countries. In addition, if equity
and credit markets deteriorate, it may make any future debt or equity financing more difficult to obtain on favorable terms, and potentially
more dilutive to existing stockholders. The Company cannot predict at this time to what extent it and its collaborators, employees, suppliers,
contract manufacturers and/or vendors could potentially be negatively impacted by these events.
The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity
threats, and has integrated these processes into its overall risk management systems and processes. The Company routinely assesses material
risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems
that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems
or any information residing therein. The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments
in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to
such cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, the
likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and
safeguards in place to manage such risks. The Company has not encountered any cybersecurity challenges to date that have materially impaired
its operations or financial condition.
10.
Subsequent Events
On
April 15, 2026, the Compensation Committee of the Board of Directors approved the cancellation of certain outstanding stock options previously
granted to the Company’s current officers and directors and, in replacement thereof, granted restricted share units (“RSUs”)
under the Company’s 2020 Stock Incentive Plan. The Company will recognize an incremental cost if the fair value is increased as a result of the modification.
On May 5, 2026, 250,000
common warrants that were included in the prefunded units of the July 2, 2025 offering, were exercised at $ 1.00 for 250,000 shares of
common stock.
30
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc. (the “Company”) contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These might
include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations,
and assumptions and predictions about future clinical trials and their timing and costs, product demand, supply, manufacturing costs,
marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “intend”,
“anticipate”, “believe”, “estimate”, “potential(ly)”, “continue”, “forecast”,
“predict”, “plan”, “may”, “will”, “could”, “would”, “should”,
“expect” or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations
reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company
cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action
that the Company may presently be planning. These forward-looking statements are inherently subject to known and unknown risks and uncertainties.
Actual results or experience may differ materially from those expected, anticipated or implied in the forward-looking statements. Factors
that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available
cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion
should be read in conjunction with the condensed consolidated financial statements and notes thereto included in Item 1 of this Quarterly
Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including the section
entitled “Item 1A. Risk Factors”. The Company does not intend to update or revise any forward-looking statements to reflect
new information, future events or otherwise.
Overview
The
Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and
commercializing cancer therapies. The Company’s corporate office is located in Pasadena, California.
The
Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents,
radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant
therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase
inhibitor, referred to as LB-100.
The
Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company
has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation
for a substantial portion of employee and consultant compensation, and is dependent on periodic access to equity capital to fund its
operating requirements.
Going
Concern
For
the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608 and used cash in operations of $1,831,363. As
of March 31, 2026, the Company had cash of $3,250,650 available to fund its operations. The Company has not generated recurring
revenues since inception and has incurred negative operating cash flows as it advances its development programs. As a result,
management has concluded that there is a substantial doubt regarding the Company’s ability to continue as a going concern for
a period of at least 12 months beyond the filing of this quarterly report. In addition, our independent registered public accounting
firm, in their audit report to the financial statements included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2025, expressed substantial doubt about the Company’s ability to continue as a going concern. The condensed
consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any
adjustments that might result from the outcome of this uncertainty.
The
Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial
research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues
for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements
and clinical trial monitoring agreements aggregated approximately $482,702 which are expected to be incurred through December 31, 2027.
In
addition, through the acquisition of Liora, the Company expects to incur approximately $2 million over the next 24 months to recommission
and update the Light machine. Liora currently has no revenues, and the Company will require additional capital to fund these activities.
31
Management
is actively evaluating and pursuing additional financing alternatives, including equity and debt financing and potential strategic transactions.
However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If
the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development
programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the
cessation of operations.
Nasdaq
Compliance
The
Company’s common stock are traded on the Nasdaq Capital Market under the symbol “LIXT”.
On
August 23, 2024, the Company received written notification from the Listing Qualifications Department (the “Staff”) of the
Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the minimum stockholders’ equity requirement
of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”).
On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement. On
October 21, 2024, the Staff provided written notification to the Company that it had granted an extension through February 18, 2025 to
regain compliance with the Stockholders’ Equity Requirement. As of February 18, 2025, the Company had not gained compliance with
the Stockholders’ Equity Requirement. Accordingly, on February 19, 2025, the Company received written notification from the Staff
stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain
compliance. The Company timely requested a hearing before the Nasdaq Hearings Panel (“Panel”), staying any suspension or
delisting pending the Panel’s decision. Following an April 3, 2025 hearing, the Panel granted the Company a further extension through
July 3, 2025 to regain compliance. On July 2, 2025, the Company closed a $5.05 million private placement and, on July 8, 2025, completed
a $1.5 million registered direct offering. On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’
equity requirement.
The
Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During this period, any future
deficiency in stockholders’ equity would require the Company to request a hearing before the Panel rather than submit a new compliance
plan.
Recent
Accounting Pronouncements
Information
with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three
months ended March 31, 2026 and 2025 included elsewhere in this document.
Critical
Accounting Policies and Estimates
The
Company’s significant accounting policies are described in Note 2 to the condensed consolidated financial statements for the three
months ended March 31, 2026 and 2025 included elsewhere in this document. These policies, together with the related estimates and
assumptions, are fundamental to understanding the Company’s results of operations and financial condition. Management evaluates
these policies and estimates on an ongoing basis based on historical experience, current conditions, and other factors deemed relevant.
There
have been no material changes to the Company’s critical accounting policies and estimates from those disclosed in the Company’s most recent Annual Report on Form 10-K.
32
Summary
of Business Activities and Plans
Company
Overview
The
Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and
commercializing cancer therapies. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A,
which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that
inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the
clinical development of a specific protein phosphatase inhibitor, referred to as LB-100.
The
Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for
clinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced
Soft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma,
all cancers of neural tissue. LB-100 has also been shown to enhance the effectiveness of commonly used anti-cancer drugs in animal models
of melanoma, breast cancer and sarcoma. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100
that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens
against many tumor types, LB-100 will improve therapeutic benefit.
As
a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment
at each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources
to manage its patent portfolio. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward
as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The
Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companies
with major programs in cancer.
Specific
Risks Associated with the Company’s Business Activities
Serious
Adverse Events
The
Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of
these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug
candidate or to another company’s drug used in combination in one of the Company’s clinical trials. It is possible that the
SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects,
treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting
toxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only
allowed at lower dose-levels that have previously been found safe.
If
an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S.
Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring
the Company to pause or discontinue further enrollment and dosing in the Company’s clinical trial. It is also possible that the
clinical trial could be terminated. Any of these actions could delay or halt the development of the Company’s drug candidate, increase
development costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval. Additionally, if an SAE
is confirmed to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further
development of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.
The
occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health
institutions, and investors, diminish the Company’s ability to attract clinical trial participants, and damage the Company’s
ability to interest investors and obtain financing in the future. There can be no assurances that the Company will not experience such
SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.
33
The
principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating
two SAEs observed in the clinical trial that was launched in August 2024. The Institutional Review Board (the “IRB”) of the
Netherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold. The adverse reactions that developed in
the two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and
atezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second
patient. The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea.
The patient with fever and aphasia fully recovered from the adverse events with supportive medication.
Given
the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study
at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information
about the mode of action of the combination of LB-100 and atezolizumab. The principal investigator prepared a response to the IRB detailing
the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicin
is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of
atezolizumab.
The
reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or
in combination with other cancer drugs. Through early July 2025, the Company has been informed that a total of 82 patients had received
or were receiving experimental treatment with LB-100.
In
May 2025, the Company updated the safety overview of LB-100 and delivered the updated version 5.0 of the Investigator’s Brochure
(the “IB”), which contains all of the relevant preclinical, clinical and pharmacologic data with respect to the study of
the LB-100 clinical compound in humans, to the investigators of all ongoing clinical trials. The investigators of the study in colorectal
cancer (NCT06012734) submitted a detailed response to the IRB, including the updated IB. The Company is currently awaiting the outcome
of the IRB review.
External
Risks Associated with the Company’s Business Activities
Covid-19
Virus . The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout
the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak has
subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital
raising efforts in the future is uncertain and cannot be predicted.
Inflation
and Interest Rate Risk. The Company does not believe that inflation or increasing interest rates have had a material effect on its
operations to date, other than their impact on the general economy. However, there is a risk that the Company’s operating costs
could become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s
operating costs, and which would put additional stress on the Company’s working capital resources.
Supply
Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,
including its ongoing clinical trials.
Potential
Recession. There have been some indications that the United States economy may be at risk of entering a recessionary period. Although
it does not appear likely at this time, an economic recession could impact the general business environment and the capital markets,
which could, in turn, affect the Company.
Geopolitical
Risk. The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of
the Company. In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may
adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally.
This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby
impeding the Company’s clinical development and commercialization plans. Furthermore, the impact of a conflict on global financial
markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s
publicly-traded shares. Investor confidence, market sentiment, and access to capital could all be negatively influenced. Such geopolitical
risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results
of operations may differ from current estimates.
34
Cybersecurity
Risks. The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity
threats, and has integrated these processes into its overall risk management systems and processes. The Company routinely assesses material
risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems
that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems
or any information residing therein. The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments
in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to
such cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, the
likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and
safeguards in place to manage such risks. The Company has not encountered any cybersecurity challenges to date that have materially impaired
its operations or financial condition.
The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.
Results
of Operations
At
March 31, 2026, the Company had not yet commenced any revenue-generating operations, does not have any positive cash flows from operations,
and is dependent on its ability to raise equity capital to fund its operating requirements.
The
Company’s condensed consolidated statements of operations as discussed herein are presented below.
Three Months Ended March 31,
2026
2025
Revenues, net
$ -
$ -
Costs and expenses:
General and administrative costs
1,654,031
615,483
Research and development costs
333,376
91,457
Total costs and expenses
1,987,407
706,940
Loss from operations
(1,987,407 )
(706,940 )
Other income (expenses):
Interest Income
3,370
441
Interest Expense
(3,094 )
(3,135 )
Foreign currency gain (loss)
(475 )
79
Net loss
$ (1,987,608 )
$ (709,555 )
Series B Convertible Preferred Stock 8% cumulative dividend
(17,882 )
-
Non-controlling interest
63,932
-
Net loss attributable to common stockholders
(1,941,558 )
(709,555 )
Net loss per common share – basic and diluted
$ (0.18 )
$ (0.29 )
Weighted average common shares outstanding – basic and diluted
10,889,003
2,471,513
35
Three
Months Ended March 31, 2026 and 2025
Revenues .
The Company did not have any revenues for the three months ended March 31, 2026 and 2025.
Research
and Development Costs . For the three months ended March 31, 2026, research and development costs were $333,376 which consisted of
clinical and related oversight costs of $309,794 and compound maintenance costs of $5,516, and preclinical research focused on development
of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $13,566.
For
the three months ended March 31, 2025, research and development costs were $91,457, which consisted of clinical and related oversight
costs of $15,868, compound maintenance costs of $32,819, and preclinical research focused on development of additional novel anti-cancer
compounds to add to the Company’s clinical pipeline of $42,770.
Research
and development expenses increased by $241,919, or 265%, in 2026 as compared to 2025. The increase was primarily attributable to a final
payment related to clinical trial engagement which increased the cost by $293,297, partially offset by a decrease in compound maintenance
costs of $56,507.
General
and Administrative Costs . For the three months ended March 31, 2026, general and administrative costs were $1,654,031 which primarily
consisted of Accounting fees of $413,504, Investment banking fees of $250,000, payroll expenses of $217,927, public relations fees of
$178,500, consulting fees related to Liora acquisition of $172,572, legal fees of $37,590, lease expense of $145, 365, Insurance expense
including D&O of $64,387, intellectual property costs of $35,032, listing fees of $14,000, Investor relations of $13,797, licenses
and royalties of $7,500, and stock-based compensation to related parties of $82,176.
For
the three months ended March 31, 2025, general and administrative costs were $615,483, which consisted of the fair value of vested stock
options issued to directors and officers of $99,738 (including quarterly director and board committee fees of $27,500), patent and licensing
legal and filing fees and costs of $56,084, other consulting and professional fees of $205,315, insurance expense of $64,277, officer
compensation and related costs of $118,268, cash-based director and board committee fees of $0, licensing and royalties of $7,397, shareholder
reporting costs of $4,811, listing fees of $33,250, filing fees of $9,750, investor relations of $11,397, taxes and licenses of $5,056,
and other operating costs of $2,998, offset by a rent refund of $2,858.
36
General
and administrative costs increased by $1,038,548 or 169%, in 2026 as compared to 2025, primarily as a result of increase in accounting fees
by $318,485, increase in investment banking fees by $221,140, increase in public relations costs by 178,500, consulting fees related
to acquisition by $172,572, increase in lease expense by $145,365, increase in payroll expense by $127,162 partially offset by decrease in legal fees by $43,847, decrease in consulting fees supporting
prior period activities with no equivalent services requested in current period, decrease in intellectual property by $21,052.
Interest
Income . For the three months ended March 31, 2026, the Company had interest income of $3,370, as compared to interest income of $441
for the three months ended March 31, 2025, due to higher average cash balance and from prevailing higher interest rates compared to three
months ended March 31, 2025.
Interest
Expense . For the three months ended March 31, 2026, the Company had interest expense of $3,094, as compared to interest expense of
$3,135 for the three months ended March 31, 2025, related to the financing of the premium for the Company’s directors and officers
liability insurance policy.
Realized
Gain (Loss) on Foreign Currency Transactions . For the three months ended March 31, 2026, the Company had a realized foreign currency
loss of $475, as compared to a foreign currency gain of $79 for the three months ended March 31, 2025, from foreign currency transactions.
Net
Loss . For the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608, as compared to a net loss of $709,555
for the three months ended March 31, 2025.
Liquidity
and Capital Resources – March 31, 2026
The
Company’s condensed consolidated statements of cash flows as discussed herein are as follows:
Three Months Ended March 31,
2026
2025
Net cash used in operating activities
$ (1,831,363 )
$ (568,483 )
Net cash used in investing activities
(24,859 )
—
Net cash provided by financing activities
—
914,228
Net increase (decrease) in cash
$ (1,856,222 )
$ 345,745
At
March 31, 2026, the Company had working capital of $2,182,816, as compared to working capital of $3,845,268 at December 31, 2025, reflecting
a net decrease in working capital of $1,662,452 for the three months ended March 31, 2026. The decrease in working capital during the
three months ended March 31, 2026 was primarily due to operating activities. As of March 31, 2026, the Company had cash of $3,250,650
available to fund its operations.
Going Concern
For the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608 and used cash in operations of $1,831,363.
As of March 31, 2026, the Company had cash of $3,250,650 available to fund its operations. The Company has not generated recurring revenues
since inception and has incurred negative operating cash flows as it advances its development programs. As a result, management has concluded
that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months
beyond the filing of this quarterly report. In addition, our independent registered public accounting firm, in their audit report to the
financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, expressed substantial
doubt about the Company’s ability to continue as a going concern.
Consideration
of Strategic Alternatives
The
Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications,
while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development
and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential
transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.
The
Company will continue to evaluate various alternatives to be able to obtain the capital required to fund its operations and business
development activities, and to maintain its listing on the Nasdaq Capital Market, including merger or acquisition opportunities (including
reverse mergers and acquisitions) and funding transactions which could result in a change in control of the Company. There can be no
assurances that the evaluation process will result in the identification of an appropriate transaction, the negotiation and execution
of a definitive agreement to effect such a transaction, or that any such transaction will ultimately be approved by the Company’s
stockholders and then be consummated. Even if such a strategic transaction is consummated, there can be no assurances that it would enhance
stockholder value, and it may result in substantial dilution to existing stockholders. Any potential transaction would be dependent on
a number of factors that may be outside of the control of the Company, including, among other things, market conditions, industry trends,
the interest of third parties in a potential transaction with the Company, and the availability of appropriate financing for such a transaction.
Trends,
Events and Uncertainties
Research
and development of new pharmaceutical compounds by its nature is unpredictable. Although the Company undertakes research and development
efforts with commercially reasonable diligence, there can be no assurance that the Company’s cash position will be sufficient to
enable it to develop any pharmaceutical compound to the extent needed to create future sales to sustain operations as contemplated herein.
37
There
can be no assurance that the Company’s pharmaceutical compound will obtain the regulatory approvals and market acceptance to achieve
sustainable revenues sufficient to support the Company’s operations. Even if the Company is able to generate revenues, there can
be no assurance that the Company will be able to achieve operating profitability or positive operating cash flows. There can be no assurance
that the Company will be able to secure additional financing, to the extent required, on acceptable terms or at all. If cash resources
are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to reduce or discontinue its
research and development programs, or attempt to obtain funds, if available, through strategic alliances, joint ventures or other transaction
structures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.
Other
than as discussed above, the Company is not currently aware of any trends, events or uncertainties that are likely to have a material
effect on its financial condition in the near term, although it is possible that new trends or events may develop in the future that
could have a material effect on the Company’s financial condition.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
The
Company’s management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined
in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), that is designed
to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized, and reported, within the time periods specified in the rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the
reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its
principal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow timely
decisions regarding required disclosure.
In
accordance with Exchange Act Rules 13a-15 and 15d-15, an evaluation was completed under the supervision and with the participation of
the Company’s management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design
and operation of the Company’s disclosure controls and procedures as of March 31, 2026, the end of the most recent fiscal period
covered by this report. Based on that evaluation, the Company’s management has concluded that the Company’s disclosure controls
and procedures were effective in providing reasonable assurance that information required to be disclosed in the Company’s reports
filed or submitted under the Exchange Act was recorded, processed, summarized, and reported within the time periods specified in the
rules and forms of the Securities and Exchange Commission.
Limitations
on Effectiveness of Disclosure Controls and Procedures
In
designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well
designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls
can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. In addition,
the design of disclosure controls and procedures must reflect that there are resource constraints and that management is required to
apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes
in Internal Control Over Financial Reporting
The
Company’s management, including its Chief Executive Officer and Chief Financial Officer, has determined that no change in the Company’s
internal control over financial reporting (as that term is defined in Rules 13(a)-15(f) and 15(d)-15(f) of the Securities Exchange Act
of 1934) occurred during the period ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect,
the Company’s internal control over financial reporting.
38
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
The
Company is not currently subject to any pending or threatened legal actions or claims.
ITEM
1A. RISK FACTORS
The
Company’s business, financial condition, results of operations and cash flows may be impacted by a number of factors, many of which
are beyond the Company’s control, including those set forth in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2025, as filed with the Securities and Exchange Commission on March 31, 2026 (the “2025 Form 10-K”).
The
Risk Factors set forth in the 2025 Form 10-K should be read carefully in connection with evaluating the Company’s business and
in connection with the forward-looking statements contained in this Quarterly Report on Form 10-Q. Any of the risks described in the
2025 Form 10-K could materially adversely affect the Company’s business, financial condition or future results, and the actual
outcome of matters as to which forward-looking statements are made. These are not the only risks that the Company faces. Additional risks
and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely
affect the Company’s business, financial condition and/or operating results.
As
of the date of the filing of this document, except as disclosed elsewhere in this document, including Note 9. Subsequent Events, there
have been no material changes to the Risk Factors previously disclosed in the Company’s 2025 Form 10-K.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
Not
applicable.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
During
the three months ended March 31, 2026, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted
or terminated
a “Rule 10b5-1 trading arrangement”, as such term is defined in Item 408(a) of Regulation S-K or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K.
39
ITEM
6. EXHIBITS
The
following documents are filed as part of this report:
Exhibit
Number
Description
of Document
3.1
Certificate of Amendment to the Certificate of Incorporation of Lixte Biotechnology Holdings, Inc., filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 6, 2023 and incorporated herein by reference.
3.2
Amended and Restated Bylaws, filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on November 10, 2022 and incorporated herein by reference.
4.1
Form of Pre-Funded Warrant to Purchase Common Stock, dated as of July 3, 2025, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 8, 2025 and incorporated herein by reference.
10.1
Form of Securities Purchase Agreement, dated as of July 3, 2025, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 8, 2025 and incorporated herein by reference.
31.1*
Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*
Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline
XBRL Instance Document (does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (formatted as Inline XBRL document and included in Exhibit 101.INS)
*
Filed herewith.
40
SIGNATURES
In
accordance with the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(Registrant)
Date:
May 14, 2026
By:
/s/
GEORDAN PURSGLOVE
Geordan
Pursglove
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
May 14, 2026
By:
/s/
PETER STAZZONE
Peter
Stazzone
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
41
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.