Form: 10-Q

Quarterly report pursuant to Section 13 or 15(d)

August 9, 2023

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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 June 30, 2023

 

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)

 

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

(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
Warrants to Purchase Common Stock, par value $0.0001 per share   LIXTW   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 August 7, 2023, the Company had 2,249,290 shares of common stock, $0.0001 par value, 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 – June 30, 2023 (Unaudited) and December 31, 2022 3
   
Condensed Consolidated Statements of Operations (Unaudited) – Three Months and Six Months Ended June 30, 2023 and 2022 4
   
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) – Three Months and Six Months Ended June 30, 2023 and 2022 5
   
Condensed Consolidated Statements of Cash Flows (Unaudited) – Six Months Ended June 30, 2023 and 2022 7
   
Notes to Condensed Consolidated Financial Statements (Unaudited) – Three Months and Six Months Ended June 30, 2023 and 2022 8
   
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 31
   
Item 3. Quantitative and Qualitative Disclosures About Market Risk 47
   
Item 4. Controls and Procedures 47
   
PART II - OTHER INFORMATION 48
   
Item 1. Legal Proceedings 48
   
Item 1A. Risk Factors 48
   
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 49
   
Item 3. Defaults Upon Senior Securities 49
   
Item 4. Mine Safety Disclosures 49
   
Item 5. Other Information 49
   
Item 6. Exhibits 50
   
SIGNATURES 51

 

2
 

 

PART I - FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   

June 30,

2023

   

December 31,

2022

 
    (Unaudited)        
             
ASSETS                
Current assets:                
Cash   $ 2,912,920     $ 5,353,392  
Advances on research and development contract services     78,015       147,017  
Prepaid insurance     54,650       49,224  
Other prepaid expenses and current assets     49,563       10,380  
Total current assets     3,095,148       5,560,013  
Total assets   $ 3,095,148     $ 5,560,013  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable and accrued expenses, including $42,500 and $46,982 to related parties at June 30, 2023 and December 31, 2022, respectively   $ 366,528     $ 229,764  
Research and development contract liabilities     36,086       165,022  
Total current liabilities     402,614       394,786  
                 
Commitments and contingencies     -       -  
                 
Stockholders’ equity:                
Preferred Stock, $0.0001 par value; authorized – 10,000,000 shares; issued and outstanding – 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 72,917 shares     3,500,000       3,500,000  
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 1,665,956 shares and 1,664,706 shares at June 30, 2023 and December 31, 2022, respectively     166       166  
Additional paid-in capital     45,623,081       45,059,760  
Accumulated deficit     (46,430,713 )     (43,394,699 )
Total stockholders’ equity     2,692,534       5,165,227  
Total liabilities and stockholders’ equity   $ 3,095,148     $ 5,560,013  

 

See accompanying notes to condensed consolidated financial statements.

 

3
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

    2023     2022     2023     2022  
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2023     2022     2023     2022  
                         
Revenues   $     $     $     $  
                                 
Costs and expenses:                        
General and administrative costs:                                
Compensation to related parties, including stock-based compensation expense of $280,060 and $424,094 for the three months ended June 30, 2023 and 2022, respectively, and $557,040 and $763,766 for the six months ended June 30, 2023 and 2022, respectively     522,561       753,530       1,042,041       1,319,452  
Patent and licensing legal and filing fees and costs     340,010       358,389       657,350       673,626  
Other costs and expenses     379,970       269,281       724,212       584,023  
Research and development costs     427,457       164,810       616,542       623,261  
Total costs and expenses     1,669,998       1,546,010       3,040,145       3,200,362  
Loss from operations     (1,669,998 )     (1,546,010 )     (3,040,145 )     (3,200,362 )
Interest income     2,714       191       7,729       300  
Interest expense     (1,948 )     (627 )     (5,809 )     (3,121 )
Foreign currency gain (loss)     877       142       2,211       (39 )
Net loss   $ (1,668,355 )   $ (1,546,304 )   $ (3,036,014 )   $ (3,203,222 )
                                 
Net loss per common share – basic and diluted   $ (1.00 )   $ (0.95 )   $ (1.82 )   $ (2.14 )
                                 
Weighted average common shares outstanding – basic and diluted     1,665,956       1,620,091       1,665,479       1,498,076  

 

See accompanying notes to condensed consolidated financial statements.

 

4
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

 

Three Months and Six Months Ended June 30, 2023 and 2022

 

    Shares     Amount     Shares     Par Value     Paid-in Capital    

Accumulated

Deficit

   

Stockholders’

Equity

 
   

Convertible

Series A

Preferred Stock

    Common Stock     Additional Paid-in     Accumulated     Total Stockholders’  
    Shares     Amount     Shares     Par Value     Capital    

Deficit

   

Equity

 
                                           
Three months ended June 30, 2023:                                                        
Balance, March 31, 2023     350,000     $ 3,500,000       1,665,956     $ 166     $ 45,343,021     $ (44,762,358 )   $ 4,080,829  
Stock-based compensation expense                             280,060             280,060  
Net loss                                   (1,668,355 )     (1,668,355 )
Balance, June 30, 2023     350,000     $ 3,500,000       1,665,956     $ 166     $ 45,623,081     $ (46,430,713 )   $ 2,692,534  
                                                         
Six months ended June 30, 2023:                                                        
Balance, December 31, 2022     350,000     $ 3,500,000       1,664,706     $ 166     $ 45,059,760     $ (43,394,699 )   $ 5,165,227  
Exercise of options                 1,250             6,281             6,281  
Stock-based compensation expense                             557,040             557,040  
Net loss                                   (3,036,014 )     (3,036,014 )
Balance, June 30, 2023     350,000     $ 3,500,000       1,665,956     $ 166     $ 45,623,081     $ (46,430,713 )   $ 2,692,534  

 

(Continued)

 

5
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

(Continued)

 

Three Months and Six Months Ended June 30, 2023 and 2022

 

   

Convertible

Series A

Preferred Stock

    Common Stock     Additional Paid-in     Accumulated     Total Stockholders’  
    Shares     Amount     Shares     Par Value    

Capital

   

Deficit

   

Equity

 
                                           
Three months ended June 30, 2022:                                                        
Balance, March 31, 2022     350,000     $ 3,500,000       1,374,706     $ 137     $ 38,712,037     $ (38,739,082 )   $ 3,473,092  
Proceeds from sale of common stock in registered direct offering, net of offering costs                 290,000       29       5,141,355             5,141,384  
Stock-based compensation expense                             424,094             424,094  
Net loss                                   (1,546,304 )     (1,546,304 )
Balance, June 30, 2022     350,000     $ 3,500,000       1,664,706     $ 166     $ 44,277,486     $ (40,285,386 )   $ 7,492,266  
                                                         
Six months ended June 30, 2022:                                                        
Balance, December 31, 2021     350,000     $ 3,500,000       1,374,706     $ 137     $ 38,372,365     $ (37,082,164 )   $ 4,790,338  
Proceeds from sale of common stock in registered direct offering, net of offering costs                 290,000       29       5,141,355             5,141,384  
Stock-based compensation expense                             763,766             763,766  
Net loss                                   (3,203,222 )     (3,203,222 )
Balance, June 30, 2022     350,000     $ 3,500,000       1,664,706     $ 166     $ 44,277,486     $ (40,285,386 )   $ 7,492,266  

 

See accompanying notes to condensed consolidated financial statements.

 

6
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    2023     2022  
    Six Months Ended June 30,  
    2023     2022  
             
Cash flows from operating activities:                
Net loss   $ (3,036,014 )   $ (3,203,222 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Stock-based compensation expense included in -                
General and administrative costs     557,040       763,766  
Research and development costs            
Changes in operating assets and liabilities:                
(Increase) decrease in -                
Advances on research and development contract services     69,002       3,224  
Prepaid insurance     (5,426 )     8,574  
Other prepaid expenses and current assets     (39,183 )     (30,313 )
Increase (decrease) in -                
Accounts payable and accrued expenses     136,764       146,743  
Research and development contract liabilities     (128,936 )     81,871  
Net cash used in operating activities     (2,446,753 )     (2,229,357 )
                 
Cash flows from financing activities:                
Exercise of common stock options     6,281        
Proceeds from sale of common stock in registered direct offering, net of offering costs           5,141,384  
Net cash provided by financing activities     6,281       5,141,384  
                 
Cash:                
Net increase (decrease)     (2,440,472 )     2,912,027  
Balance at beginning of period     5,353,392       4,823,745  
Balance at end of period   $ 2,912,920     $ 7,735,772  
                 
Supplemental disclosures of cash flow information:                
Cash paid for -                
Interest   $ 5,809     $ 3,121  
Income taxes   $     $  

 

See accompanying notes to condensed consolidated financial statements.

 

7
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

Three Months and Six Months Ended June 30, 2023 and 2022

 

1. Organization and Basis of Presentation

 

The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at June 30, 2023, and for the three months and six months ended June 30, 2023 and 2022, are unaudited. 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 June 30, 2023, and the results of its operations for the three months and six months ended June 30, 2023 and 2022, and its cash flows for the six months ended June 30, 2023 and 2022. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2022 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 (the “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, 2022, as filed with the SEC.

 

Reverse Stock Split

 

On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole share.

 

All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.

 

Nasdaq Notification of Failure to Satisfy a Continued Listing Rule

 

The Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively.

 

On June 24, 2022, the Company received a written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a period of 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. The Notice had no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market.

 

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of the Notice, or until December 21, 2022, to regain compliance with the minimum closing bid price requirement. On December 22, 2022, the Company received a written notice from Nasdaq that the Company was eligible for a second 180 calendar day compliance period, or until June 19, 2023, in order to regain compliance with the $1.00 minimum bid price requirement. Nasdaq’s determination to grant the second compliance period was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

 

8
 

 

A company can generally achieve compliance with the minimum closing bid price requirement if the minimum closing bid price of a company’s common stock is at least $1.00 per share for a minimum of 10 consecutive business days during the 180-day compliance period. However, under certain circumstances, Nasdaq can extend this 10-day trading period up to a maximum of 20 days.

 

In order to achieve compliance with the minimum closing bid price requirement, the Company filed a proxy statement with the SEC to hold a special meeting of stockholders on May 26, 2023 to seek stockholder approval to approve an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock at a split ratio of up to a maximum of a 1-for-10 split, as determined by the Board of Directors in its sole discretion.

 

The stockholders approved an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock, as a result of which the Company effected a 1-for-10 reverse stock split of its issued and outstanding common stock effective on Friday, June 2, 2023. Commencing with the opening of trading on the Nasdaq Capital Market on Monday, June 5, 2023, the Company’s common stock began trading on a post-split basis under the same symbol LIXT. The Company subsequently received confirmation from Nasdaq that it had regained compliance with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2) and currently meets all other applicable criteria for continued listing.

 

However, there can be no assurances that the Company will be able to remain in compliance with the minimum bid price requirement over time, or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements.

 

2. Business

 

The Company is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California.

 

The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity.

 

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.

 

Sale of Common Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-Funded Common Stock Purchase Warrants

 

Subsequent to June 30, 2023, on July 20, 2023, in a registered direct offering to an institutional investor, the Company sold 180,000 shares of common stock at a purchase price of $6.00 per share and pre-funded warrants to purchase 403,334 shares of common stock at a purchase price of $5.9999 per pre-funded warrant. Each pre-funded warrant had an exercise price of $0.0001 per share, was immediately exercisable upon issuance, and was valid and exercisable until all pre-funded warrants are exercised in full.

 

In a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock. Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years thereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

 

9
 

 

The registered direct offering and the concurrent private placement generated gross proceeds of approximately $3,500,000. The total cash costs of the registered direct offering and the private placement were approximately $375,000, resulting in net proceeds of approximately $3,125,000. Pursuant to the placement agent agreement, the Company granted to the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share and expiring on July 20, 2028.

 

During the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants exercisable at $0.0001 per share were exercised for total cash proceeds of $40, resulting in the issuance of 403,334 shares of common stock.

 

Going Concern

 

At June 30, 2023, the Company had cash of $2,912,920 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At June 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $6,389,000 (see Note 9), which are currently scheduled to be incurred through approximately December 31, 2025.

 

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities.

 

Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.

 

Based on current operating plans, the Company estimates that existing cash resources, together with the proceeds from the July 20, 2023 registered direct offering and concurrent private placement, will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2024. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, no later than the latter half of the fiscal year ending December 31, 2024. However, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned.

 

As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

 

If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.

 

10
 

 

3. Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation.

 

Segment Information

 

The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer.

 

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. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. 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, valuing equity instruments issued for services, and the realization of deferred tax assets.

 

Cash

 

Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not experienced any losses to date resulting from this policy.

 

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development 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 the 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.

 

11
 

 

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.

 

Prepaid Insurance

 

Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each reporting period.

 

Patent and Licensing Legal and Filing Fees and Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and 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 $340,010 and $358,389 for the three months ended June 30, 2023 and 2022, respectively, and $657,350 and $673,626 for the six months ended June 30, 2023 and 2022, respectively. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statements 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 time 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 and six months ended June 30, 2023 and 2022 are described as follows.

 

General and administrative costs for the three months ended June 30, 2023 and 2022 included charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.3% and 25.9% of total general and administrative costs, respectively. General and administrative costs for the three months ended June 30, 2023 and 2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 22.5% and 30.7%, respectively, of total general and administrative costs.

 

Research and development costs for the three months ended June 30, 2023 included charges from two vendors and consultants representing 62.9% and 12.4%, respectively, of total research and development costs. Research and development costs for the three months ended June 30, 2022 include charges from five vendors and consultants representing 29.7%, 18.2%, 17.4%, 12.6%, and 10.2%, respectively, of total research and development costs.

 

General and administrative costs for the six months ended June 30, 2023 and 2022 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.1% and 26.1% of total general and administrative costs, respectively. General and administrative costs for the six months ended June 30, 2023 and 2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 23.0% and 29.6%, respectively, of total general and administrative costs.

 

Research and development costs for the six months ended June 30, 2023 include charges from three vendors and consultants representing 43.9%, 17.1% and 11.2%, respectively, of total research and development costs. Research and development costs for the six months ended June 30, 2022 include charges from two vendors and consultants representing 44.6% and 16.5%, respectively, of total research and development costs.

 

12
 

 

Income Taxes

 

The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities.

 

The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

 

The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of June 30, 2023 or December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023.

 

The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of June 30, 2023 or December 31, 2022. Subsequent to June 30, 2023, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense.

 

Stock-Based Compensation

 

The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, 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, Scientific Advisory Committee members, 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.

 

13
 

 

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. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive.

 

At June 30, 2023 and 2022, 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.

    2023     2022  
    June 30,  
    2023     2022  
             
Series A Convertible Preferred Stock     72,917       72,917  
Common stock warrants     190,031       340,031  
Common stock options, including options issued in the form of warrants     428,229       332,500  
Total     691,177       745,448  

 

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 (consisting 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.

 

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Recent Accounting Pronouncements

 

In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 was effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s consolidated financial statement presentation or related disclosures.

 

In July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As the ASU does not provide any new guidance, there is no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03 immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial statement presentation or related disclosures.

 

Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures.

 

4. Research and Development Costs

 

A summary of research and development costs for the three months and six months ended June 30, 2023 and 2022, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where such costs have been incurred.

 

    2023     2022     2023     2022  
   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
    2023     2022     2023     2022  
                         
United States   $ 87,625     $ 80,290     $ 223,531     $ 154,821  
Spain     272,564       18,774       273,539       347,604  
China     14,090       16,860       14,090       17,720  
Netherlands     53,178       48,886       105,382       103,116  
Total   $ 427,457     $ 164,810     $ 616,542     $ 623,261  

 

5. 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 and are not subject to increase without the written consent of a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the Preferences, Rights and Limitations. The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of June 30, 2023 and December 31, 2022, the Company had 9,650,000 shares of undesignated preferred stock which may be issued with such rights and powers as the Board of Directors may designate.

 

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Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 0.20833 shares of common stock (subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. The Series A Convertible Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred Stock does not have any cash liquidation preference rights or any registration rights. If fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 72,917 shares of common stock at June 30, 2023 and December 31, 2022.

 

Based on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible Preferred Stock as a permanent component of stockholders’ equity.

 

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 June 30, 2023 and December 31, 2022, the Company had 1,665,956 shares and 1,664,706 shares, respectively, of common stock issued and outstanding.

 

On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole share. All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.

 

Effective April 12, 2022, the Company completed the sale of 290,000 shares of common stock at a price of $20.00 per share in a registered direct offering, generating gross proceeds of $5,800,000. The total cash costs of this offering were $658,616, resulting in net proceeds of $5,141,384. Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 29,000 shares of common stock at an exercise price of $20.00 per share exercisable through April 14, 2027.

 

Effective March 10, 2023, the Company issued 1,250 shares of common stock upon the exercise of a stock option in the form of a warrant held by a consultant to the Company for 1,250 shares exercisable at $5.025 per share for total cash proceeds of $6,281.

 

Common Stock Warrants

 

A summary of common stock warrant activity during the six months ended June 30, 2023 is presented below.

    Number of Shares    

Weighted Average

Exercise Price

   

Weighted Average

Remaining

Contractual

Life (in Years)

 
                   
Warrants outstanding at December 31, 2022     190,031     $ 50.161          
Issued                    
Exercised                    
Expired                    
Warrants outstanding at June 30, 2023     190,031     $ 50.161       2.65  
                         
Warrants exercisable at December 31, 2022     190,031     $ 50.161          
Warrants exercisable at June 30, 2023     190,031     $ 50.161       2.65  

 

At June 30, 2023, the outstanding warrants are exercisable at the following prices per common share:

Exercise

Prices

   

Warrants

Outstanding

(Shares)

 
$ 20.000       29,000  
$ 37.000       11,331  
$ 57.000       149,700  
          190,031  

 

16
 

 

The warrants exercisable at $57.00 per share at June 30, 2023 include publicly-traded warrants that were issued as part of the Company’s November 2020 public offering of units and are exercisable for a period of five years thereafter. As a result of the 1-for-10 reverse split of the Company’s common stock effective June 2, 2023, each such publicly-traded warrant currently represents the right to purchase 1/10th of a share of common stock at the original exercise price of $5.70 per share. Accordingly, upon exercise, a warrant holder will be required to present ten warrants, each exercisable at $5.70, to acquire one share of post-split common stock, which is equivalent to a purchase price of $57.00.

 

Based on a fair market value of $5.88 per share on June 30, 2023, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2023.

 

Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 7.

 

6. Related Party Transactions

 

Related party transactions include transactions with the Company’s officers, directors and affiliates.

 

Employment Agreements with Officers

 

During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. The employment agreements are automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021 and 2022.

 

The Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, for Dr. Kovach to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $250,000. During the three months ended June 30, 2023 and 2022, the Company paid $62,500 and $62,500, respectively, to Dr. Kovach under this employmentagreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company paid $125,000 and $125,000, respectively, to Dr. Kovach under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.

 

The Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief Medical Officer, with an annual salary of $150,000. Effective May 1, 2021, Dr. Miser’s annual salary was increased to $175,000. Dr. Miser is required to devote at least 50% of his business time to the Company’s activities. During the three months ended June 30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Dr. Miser under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company paid $87,500 and $87,500, respectively, to Dr. Miser under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.

 

The Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the Company’s Chief Administrative Officer, with an annual salary of $120,000. Mr. Forman is the son-in-law of Gil Schwartzberg (deceased), a former member of the Company’s Board of Directors who died on October 30, 2022 and was a significant stockholder of and consultant to the Company, and is the son of Dr. Stephen Forman, a member of the Company’s Board of Directors. Julie Forman, the wife of Mr. Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, at which firm the Company’s cash is on deposit and with which the Company maintains a continuing banking relationship. Effective May 1, 2021, Mr. Forman’s annual salary was increased to $175,000. Additionally, effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer with an annual salary of $200,000. Effective October 1, 2022, Mr. Forman has been provided a monthly office rent allowance, pursuant to which Mr. Forman was paid $1,530 and $4,113, respectively, for the three months and six months ended June 30, 2023. During the three months ended June 30, 2023 and 2022, the Company paid $50,000 and $43,750, respectively, to Mr. Forman under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company paid $100,000 and $87,500, respectively, to Mr. Forman under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.

 

17
 

 

The Company entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice President and Chief Financial Officer, with an annual salary of $120,000. Effective May 1, 2021, Mr. Weingarten’s annual salary was increased to $175,000. During the three months ended June 30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Mr. Weingarten under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company paid $87,500 and $87,500, respectively, to Mr. Weingarten under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.

 

Appointment of Dr. René Bernards to the Board of Directors

 

Effective as of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr. Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. As a new director, in lieu of a grant of stock options, Dr. Bernards received a one-time cash board fee of $100,000, which was paid upon his appointment to the Board of Directors, and an annual cash board fee of $40,000, payable quarterly.

 

Previously, on October 8, 2021, the Company had entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, 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, as described at Note 9.

 

Compensatory Arrangements for Members of the Board of Directors

 

Effective April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the independent members of the Board of Directors and committee members. Effective May 25, 2022, the Board of Directors approved an amendment to the program. Officers who also serve on the Board of Directors are not compensated separately for their service on the Board of Directors.

 

Cash compensation for independent directors, payable quarterly, is as follows:

 

Base director compensation - $20,000 per year

Chairman of audit committee – additional $10,000 per year

Chairman of any other committees – additional $5,000 per year

Member of audit committee – additional $5,000 per year

Member of any other committees – additional $2,500 per year

 

Equity compensation for independent directors is as follows:

 

Appointment of new independent directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject to continued service. At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company may elect to pay a one-time cash fee of $100,000 to such director, payable upfront.

 

Annual grant of options to independent directors – Effective on the last business day of the month of June, the Company grants options to purchase 10,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant, vesting 12.5% on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully vested, subject to continued service. If any director has served for less than 12 full calendar months at the grant date, the amount of such stock option grant shall be prorated based on the length of service of such director. At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company may elect to pay an annual cash fee of $40,000 to such director, payable quarterly.

 

18
 

 

Total cash compensation paid to independent directors was $42,501 and $135,686, respectively, for the three months ended June 30, 2023 and 2022. Total cash compensation paid to independent directors was $85,001 and $168,186, respectively, for the six months ended June 30, 2023 and 2022.

 

Stock-based compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 7.

 

A summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors for their services on the Board of Directors, for the three months and six months ended June 30, 2023 and 2022, is presented below.

 

    2023     2022     2023     2022  
   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
    2023     2022     2023     2022  
                         
Related party costs:                                
Cash-based   $ 242,501     $ 329,436     $ 485,001     $ 555,686  
Stock-based     280,060       424,094       557,040       763,766  
Total   $ 522,561     $ 753,530     $ 1,042,041     $ 1,319,452  

 

7. 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.

 

On July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently approved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates, initially for a total of 233,333 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. On October 7, 2022, the stockholders of the Company approved an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.

 

As of June 30, 2023, unexpired stock options for 300,313 shares were issued and outstanding under the 2020 Plan and 113,020 shares were available for issuance under the 2020 Plan.

 

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 six months ended June 30, 2023, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions:

Risk-free interest rate     4.565 %
Expected dividend yield     0 %
Expected volatility     138.05 %
Expected life     3.5 years  

 

19
 

 

For stock options requiring an assessment of value during the six months ended June 30, 2022, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions:

 

Risk-free interest rate     3.03 %
Expected dividend yield     0 %
Expected volatility     153.17 %
Expected life     3.5 years  

 

On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $24,985, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $49,695 and $49,695, respectively, with respect to these stock options.

 

On August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted stock options to purchase 8,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s common stock on the effective date of the employment agreement. The options vested 25% on August 1, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 1, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($68.718 per share), of which $143,163 was attributable to the portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 1, 2020 through August 1, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $35,693 and $35,693, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $70,993 and $70,993, respectively, with respect to these stock options.

 

On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $24,985, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $49,695 and $49,695, respectively, with respect to these stock options.

 

On April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $753,611 ($30.144 per share), of which $376,800 was attributable to the portion of the stock options fully vested on April 9, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023. However, vesting of these stock options terminated on October 30, 2022, the date that Mr. Schwartzberg died. During the three months and six months ended June 30, 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $42,228 and $83,992, respectively, with respect to these stock options.

 

20
 

 

On May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Ms. Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($26.335 per share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from May 11, 2021 through June 30, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $38,405 and $38,405, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $76,388 and $76,388, respectively, with respect to these stock options.

 

On June 30, 2021, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $30.30 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $1,421,095 ($28.423 per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $106,290 and $177,150, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $211,412 and $352,355, respectively, with respect to these stock options.

 

On June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share), of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June 17, 2022 through June 30, 2024. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $9,695 and $80,647, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $19,284 and $80,647, respectively, with respect to these stock options.

 

On June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $23,655 and $0, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $47,049 and $0, respectively, with respect to these stock options.

 

21
 

 

On November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares (a total of 80,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $20.00 per share, vesting 25% on issuance and 25% on each anniversary date thereafter until fully vested, subject to continued service. The total fair value of the 80,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $262,560 ($3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025. During the three months and six months ended June 30, 2023, the Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $16,352 and $32,524, respectively, with respect to these stock options.

 

On November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 shares of the Company’s common stock, which was fully vested upon issuance and is exercisable for a period of five years at $5.025 per share (the closing market price on the issue date). The fair value of the warrant, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $43,264 ($4.326 per share) and was charged to general and administrative costs in the consolidated statement of operations on that date.

 

On June 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a total of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $5.88 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $192,593 ($4.8131 per share), which is being charged to operations ratably from July 1, 2023 through June 30, 2025. During the three months and six months ended June 30, 2023, the Company did not record a charge to operations with respect to these stock options.

 

Dr. Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the Company’s Annual Meeting of Stockholders held on October 7, 2022, and Gil Schwartzberg, a director of the Company, died on October 30, 2022. Accordingly, the unvested stock options for each such person ceased vesting effective as of the respective dates that their service on the Company’s Board of Directors terminated. Furthermore, the expiration date of all vested stock options owned by such persons are contractually scheduled to expire one year from the respective dates that their service on the Company’s Board of Directors terminated.

 

A summary of stock-based compensation costs for the three months and six months ended June 30, 2023 and 2022 is as follows:

    2023     2022     2023     2022  
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2023     2022     2023     2022  
                         
Related parties   $ 280,060     $ 424,094     $ 557,040     $ 763,766  
Non-related parties                        
Total stock-based compensation costs   $ 280,060     $ 424,094     $ 557,040     $ 763,766  

 

A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 2023 is as follows:

    Number of Shares    

Weighted Average

Exercise

Price

   

Weighted Average Remaining Contractual Life

(in Years)

 
                   
Stock options outstanding at December 31, 2022     389,479     $ 29.1826          
Granted     40,000       5.8800          
Exercised     (1,250 )     5.0250          
Expired                    
Stock options outstanding at June 30, 2023     428,229     $ 27.0764       2.77  
                         
Stock options exercisable at December 31, 2022     281,979     $ 32.8335          
Stock options exercisable at June 30, 2023     301,979     $ 31.9708       2.75  

 

22
 

 

Total deferred compensation expense for the outstanding value of unvested stock options was approximately $517,000 at June 30, 2023, which will be recognized subsequent to June 30, 2023 over a weighted-average period of approximately 21 months.

 

The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 30, 2023 are as follows:

Exercise

Prices

   

Options

Outstanding

(Shares)

   

Options

Exercisable

(Shares)

 
               
$ 5.025       8,750       8,750  
$ 5.880       40,000        
$ 7.400       57,500       36,250  
$ 16.800       3,333       3,333  
$ 20.000       80,000       20,000  
$ 20.600       20,000       20,000  
$ 28.000       25,000       25,000  
$ 30.000       66,667       66,667  
$ 30.300       42,500       42,500  
$ 32.000       20,313       20,313  
$ 32.100       15,000       15,000  
$ 60.000       16,667       16,667  
$ 66.000       4,167       4,167  
$ 71.400       20,000       15,000  
$ 120.000       8,332       8,332  
          428,229       301,979  

 

The intrinsic value of exercisable but unexercised in-the-money stock options at June 30, 2023 was approximately $7,500, based on a fair market value of $5.88 per share on June 30, 2023.

 

Outstanding stock options to acquire 126,250 shares of the Company’s common stock had not vested at June 30, 2023.

 

The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.

 

8. Income Taxes

 

During the three months and six months ended June 30, 2023 and 2022, the Company did not record any provision for income taxes, as the Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company has recorded a full valuation allowance against its deferred tax assets for all periods presented as the Company currently believes it is more likely than not that the deferred tax assets will not be realized.

 

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 June 30, 2023 and December 31, 2022, the Company was not subject to any pending or threatened legal claims or actions.

 

23
 

 

Principal Commitments

 

Clinical Trial Agreements

 

At June 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $6,389,000, which are currently scheduled to be incurred through approximately December 31, 2025. 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 are frequently modified, suspended or terminated 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 revisions over time.

 

Moffitt. Effective August 20, 2018, the Company entered into a five-year Clinical Trial Research Agreement with the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida. Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS).

 

In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy.

 

During the three months ended June 30, 2023, the Phase 1b/2 clinical trial at the Moffitt Cancer Center evaluating LB-100 in patients with MDS was closed by the principal investigator. In this clinical trial, single agent LB-100 was used on a new schedule of days 1, 3, and 5 every 3 weeks. It was determined that patients found it too challenging to go for an infusion given on this schedule. The Company is not employing this schedule in its other clinical trials. Although the Maximally Tolerated Dose (MTD) was not achieved, there was no dose-limiting toxicity on this schedule at doses that were even greater than those which were above the MTD in the Phase 1 clinical trial of LB-100 on the Monday, Tuesday, Wednesday schedule.

 

During the three months ended June 30, 2023 and 2022, the Company incurred costs of $6,000 and $6,073, respectively, pursuant to this agreement, which have been included in research and development costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $12,000 and $9,405, respectively, pursuant to this agreement, which have been included in research and development costs in the Company’s consolidated statements of operations. As of June 30, 2023, total costs of $143,074 have been incurred pursuant to this agreement. Nominal trailing costs subsequent to June 30, 2023 are expected relating to the closure of this study.

 

The Company has decided not to pursue further studies in MDS, as other opportunities in much more common diseases have become available. For example, the Company is now focusing on documenting clear-cut potentiation of cytotoxic treatment as in the ongoing study of advanced soft tissue sarcoma and small cell lung cancer. In addition, new pre-clinical data demonstrate the potentiation of immunotherapy by LB-100 in other common cancers.

 

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 therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 consistently enhances the anti-tumor activity of doxorubicin without apparent increases in toxicity.

 

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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 years. As advanced sarcoma is a very aggressive disease, the design 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 practices (GMP) of the active pharmacologic 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.

 

As of June 30, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially for subsequent multiple trials within the European Union, had cost approximately $1,144,000. Although the production of new inventory has been completed, nominal trailing costs subsequent to June 30, 2023 are expected to be incurred.

 

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 advanced soft tissue sarcomas (ASTS). Consequently, the GEIS clinical trial commenced during the quarter ending June 30, 2023 and is expected to be completed by December 31, 2025. 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 Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on both response and toxicity from this portion of the clinical trial.

 

The interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone.

 

The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $268,829 and $0, respectively, pursuant to this agreement. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $268,829 and $0, respectively, pursuant to this agreement. Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of operations. Through June 30, 2023, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through the fourth milestone.

 

The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,536,000 as of June 30, 2023, which is expected to be incurred through December 31, 2025. 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.

 

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City of Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with a standard regimen for treatment of untreated extensive- stage disease small cell lung cancer (ED-SCLC). LB-100 will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, to previously untreated ED-SCLC patients. The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival.

 

The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as patient accrual was slower than expected, the Company has been seeking to add two additional sites to increase the rate of patient accrual. Effective March 6, 2023, the Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, joined the City of Hope’s ongoing Phase 1b clinical trial. The Company is continuing its efforts to add a third site. The addition of SCRI is expected to expedite and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard treatment regimen. With the addition of SCRI, the Company currently expects that this clinical trial will be completed by December 31, 2024.

 

During the three months ended June 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $69,001 and $0, respectively, pursuant to this agreement, which are included in research and development costs in the Company’s consolidated statements of operations. As of June 30, 2023, total costs of $447,512 have been incurred pursuant to this agreement.

 

The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000 as of June 30, 2023, which is expected to be incurred through December 31, 2024. If a significant number of patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately $800,000.

 

The Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment of a very aggressive disease.

 

Theradex. On June 22, 2023, the Company finalized a work order agreement with Theradex Systems, Inc. (“Theradex”), an international contract research organization (“CRO”), to conduct a Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcomas. The study is expected to be completed by December 31, 2025.

 

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 and six months ended June 30, 2023, the Company incurred costs of $6,250 pursuant to this work order. As of June 30, 2023, total costs of $6,250 have been incurred 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 $153,000 as of June 30, 2023, which is expected to be incurred through December 31, 2025.

 

National Cancer Institute Pharmacologic Clinical Trial. In May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic clinical trial. This study is being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the Company responsible for providing the LB-100 clinical compound.

 

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Primary malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain is not known. Unfortunately, many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

 

The NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove one or more tumors will receive one dose of LB-100 prior to surgery and have blood and tumor tissue analyzed to determine the amount of LB-100 present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular target. As a result of the innovative design of the NCI study, data from a few patients should be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs. Five patients have been entered and analysis of the blood and tissue has proceeded. If there is evidence in at least two of the patients of penetration of LB 100 into tumor tissue, the study will be deemed as successful. Results of this study are currently being reviewed by NCI and a report is expected by the end of 2023.

 

Clinical Trial Monitoring Agreements

 

Moffitt. On September 12, 2018, the Company finalized a work order agreement with Theradex (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019.

 

The costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic documentation provided by the CRO. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $10,997 and $4,558, respectively, pursuant to this work order. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $20,284 and $7,839, respectively, pursuant to this work order. As of June 30, 2023, total costs of $147,572 have been incurred pursuant to this work order agreement.

 

During the three months ended June 30, 2023, concurrent with the closure of the Company’s Clinical Trial Research Agreement with Moffitt, this work order agreement with Theradex to monitor the Clinical Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to June 30, 2023 are expected to be incurred relating to the closure of the Moffitt study.

 

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 are estimated to be approximately $335,000. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $5,687 and $11,235, respectively, pursuant to this work order. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $11,240 and $15,735, respectively, pursuant to this work order. As of June 30, 2023, total costs of $69,681 have been incurred 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 $267,000 as of June 30, 2023, which is expected to be incurred through December 31, 2025.

 

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Patent and License Agreements

 

Moffitt. Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. The Company is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum royalty payments. The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. During the three months ended June 30, 2023 and 2022, the Company recorded charges to operations of $6,233 and $6,233, respectively, in connection with its obligations under the License Agreement. During the six months ended June 30, 2023 and 2022, the Company recorded charges to operations of $12,398 and $12,398, respectively, in connection with its obligations under the License Agreement. As of June 30, 2023, no milestones had yet been attained.

 

The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries.

 

Employment Agreements with Officers

 

During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual compensation of $640,000, payable monthly (see Note 6). The employment agreements are automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021 and 2022.

 

On April 9, 2021, the Board of Directors increased the annual compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten under the employment agreements, such that the total aggregate annual compensation of all officers increased to $775,000, effective May 1, 2021.

 

Effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000. In addition, Mr. Forman is being provided an office allowance of approximately $1,500 per month through December 31, 2023.

 

The total aggregate annual compensation of all officers increased to $800,000, effective November 6, 2022, which has continued through June 30, 2023.

 

Other Significant Agreements and Contracts

 

NDA Consulting Corp. On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $4,000 for the three months ended June 30, 2023 and 2022, respectively, and $8,000 and $8,000 for the six months ended June 30, 2023 and 2022, which were included in research and development costs in the consolidated statements of operations.

 

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. Those services included, among other things, assisting the Company to commercialize its products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company’s product pipeline; assisting in preparing technical presentations concerning the Company’s products; consultation in drug discovery and development; and identifying providers and overseeing tasks relating to clinical development of new compounds.

 

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BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly payment, and agreed to issue to BioPharmaWorks certain equity-based compensation (see Note 7). The Company recorded charges to operations pursuant to this Collaboration Agreement of $30,000 and $30,000 for the three months ended June 30, 2023 and 2022, respectively, and $60,000 and $60,000 for the six months ended June 30, 2023 and 2022, 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 (see Note 6), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, 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 has agreed to fund the study and provide a sufficient supply of LB-100 to conduct the study. The study is expected to take approximately two years to conduct. During the three months ended June 30, 2023 and 2022, the Company incurred charges in the amount of $53,178 and $48,886, respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements of operations. During the six months ended June 30, 2023 and 2022, the Company incurred charges in the amount of $105,381 and $103,116, respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements of operations. As of June 30, 2023, total costs of $364,788 have been incurred pursuant to this agreement. The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $53,000 as of June 30, 2023, which is expected to be incurred through June 30, 2025. 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. The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials in the United States. On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 for services to be rendered through April 30, 2023. Effective April 17, 2023, the contract was further amended to reflect a new total contract price of $326,274 for services to be rendered through April 30, 2024. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $4,010 and $19,597, respectively, pursuant to this contract. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $7,183 and $20,353, respectively, pursuant to this work order. As of June 30, 2023, total costs of $225,924 have been incurred pursuant to this contract.

 

The Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $100,000 as of June 30, 2023.

 

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. 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 Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its 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 (including, specifically, clinical trial 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.

 

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Potential Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn, affect the Company.

 

The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available.

 

10. Subsequent Events

 

The Company performed an evaluation of subsequent events through the date of filing of these condensed consolidated financial statements with the SEC. Other than those matters described below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in the condensed consolidated financial statements.

 

Sale of Common Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-Funded Common Stock Purchase Warrants

 

On July 20, 2023, in a registered direct offering to an institutional investor, the Company sold 180,000 shares of common stock at a purchase price of $6.00 per share and pre-funded warrants to purchase 403,334 shares of common stock at a purchase price of $5.9999 per pre-funded warrant. Each pre-funded warrant had an exercise price of $0.0001 per share, was immediately exercisable upon issuance, and was valid and exercisable until all pre-funded warrants are exercised in full.

 

In a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock. Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years thereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

 

The registered direct offering and the concurrent private placement generated gross proceeds of approximately $3,500,000. The total cash costs of the registered direct offering and the private placement were approximately $375,000, resulting in net proceeds of approximately $3,125,000. Pursuant to the placement agent agreement, the Company granted to the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share and expiring on July 20, 2028.

 

During the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants exercisable at $0.0001 per share were exercised for total cash proceeds of $40, resulting in the issuance of 403,334 shares of common stock.

 

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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, 2022, 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 drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California.

 

The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity.

 

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.

 

Reverse Stock Split

 

On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole share.

 

All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.

 

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Recent Developments

 

News Release

 

On July 17, 2023, the Company issued a news release announcing that a recently posted article in BioRxiv based on the results of a collaboration between the Company and the Netherlands Cancer Institute, shows that inhibition of PP2A in colon cancer cells, using LIXTE’s lead clinical compound LB-100, leads to major changes in the way cancer cells process their mRNAs.

 

Based on this finding, the Company indicated that cancer cells are predicted to produce a significant number of aberrant proteins that can be recognized by the immune system. This newly discovered mechanism, by which LB-100 turns immunologically “cold” tumors “hot,” adds to several additional mechanisms that have recently been described through which LB-100 sensitizes cancer cells to immune checkpoint blockade.

 

The Company said the new research also shows that disruption of proper mRNA maturation induced by LB-100 leads to a reduced ability of the cancer cells to deal with DNA damage. This finding concurs with multiple pre-clinical studies demonstrating synergy between LB-100 and radiotherapy or different chemotherapies in various cancer models.

 

The July 13, 2023 BioRxiv article, titled “PP2A Inhibition Instructs Spliceosome Phosphorylation to Create Splicing Vulnerability in Colon Adenocarcinoma,” was authored by Dias et. al. from the Netherlands Cancer Institute, in a collaboration that the Company initiated in 2021 with a team of scientists headed by René Bernards, a Professor of Molecular Carcinogenesis at the Netherlands Cancer Institute and a member of the Company’s Board of Directors.

 

Sale of Common Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-Funded Common Stock Purchase Warrants

 

On July 20, 2023, in a registered direct offering to an institutional investor, the Company sold 180,000 shares of common stock at a purchase price of $6.00 per share and pre-funded warrants to purchase 403,334 shares of common stock at a purchase price of $5.9999 per pre-funded warrant. Each pre-funded warrant had an exercise price of $0.0001 per share, was immediately exercisable upon issuance, and was valid and exercisable until all pre-funded warrants are exercised in full.

 

In a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock. Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years thereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

 

The registered direct offering and the concurrent private placement generated gross proceeds of approximately $3,500,000. The total cash costs of the registered direct offering and the private placement were approximately $375,000, resulting in net proceeds of approximately $3,125,000. Pursuant to the placement agent agreement, the Company granted to the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share and expiring on July 20, 2028.

 

During the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants exercisable at $0.0001 per share were exercised for total cash proceeds of $40, resulting in the issuance of 403,334 shares of common stock.

 

Going Concern

 

At June 30, 2023, the Company had cash of $2,912,920 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At June 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $6,389,000 (see “Principal Commitments” below), which are currently scheduled to be incurred through approximately December 31, 2025.

 

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities.

 

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Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.

 

Based on current operating plans, the Company estimates that existing cash resources, together with the proceeds from the July 20, 2023 registered direct offering and concurrent private placement, will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2024. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, no later than the latter half of the fiscal year ending December 31, 2024. However, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned.

 

As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

 

If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.

 

Recent Accounting Pronouncements

 

Information with respect to recent accounting pronouncements is provided at Note 3 to the condensed consolidated financial statements for the three months and six months ended June 30, 2023 and 2022 included elsewhere in this document.

 

Concentration of Risk

 

Information with respect to concentration of risk is provided at Note 3 to the condensed consolidated financial statements for the three months and six months ended June 30, 2023 and 2022 included elsewhere in this document.

 

Critical Accounting Policies and Estimates

 

The preparation of the Company’s consolidated financial statements in conformity with generally accepted accounting principles in the United States (“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. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. 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, valuing equity instruments issued for services, and the realization of deferred tax assets.

 

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The following critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company’s consolidated financial statements.

 

Cash

 

Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not experienced any losses to date resulting from this policy.

 

Segment Information

 

The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer.

 

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development 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 the 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.

 

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Patent and Licensing Legal and Filing Fees and Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs are charged to operations as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statements of operations.

 

During the three months ended June 30, 2023 and 2022, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $340,010 and $358,389, respectively, a decrease of $18,379, or 5.1% in 2023, as compared to 2022. During the six months ended June 30, 2023 and 2022, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $657,350 and $673,626, respectively, a decrease of $16,276, or 2.4% in 2023, as compared to 2022.

 

In late 2021, the Company engaged a new patent law firm that is highly regarded for its expertise in biotechnology. This firm conducted a comprehensive analysis of the Company’s extensive patent portfolio in order to implement a program to maximize intellectual property protection, both domestically and internationally. As a result, several patents were filed in 2022, reflecting potential new uses of the Company’s lead clinical compound LB-100 in cancer therapy. The Company expects that patent and licensing legal and filing fees and costs will remain relatively stable for the remainder of 2023 as compared to 2022, as the Company continues to focus on efforts to expand clinical programs to analyze various potential uses for LB-100 and to develop and expand its patent portfolio related to the clinical development of LB-100.

 

A descriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100, as well as a detailed listing of each domestic and international patent that has been issued, is presented at “ITEM 1. BUSINESS – Intellectual Property” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

 

Stock-Based Compensation

 

The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, 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, Scientific Advisory Committee members, 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.

 

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.

 

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Summary of Business Activities and Plans

 

Company Overview

 

The Company is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases.

 

The Company is focusing its development activities on its LB-100 series of drugs. The Company believes that the mechanism by which compounds of the LB-100 series affect cancer cell growth is different from cancer agents currently approved for clinical use. Lead compounds from each series have activity against a broad spectrum of common and rarer human cancers in cell culture systems. In addition, compounds from both series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. Lead compounds of the LB-100 series also have activity against melanoma, breast cancer and sarcoma in animal models and enhance the effectiveness of commonly used anti-cancer drugs in these animal models. 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, the Company’s compounds will improve therapeutic benefit without enhancing toxicity in humans. The Company is not currently planning to allocate resources to further develop its LB-200 series of drugs,

 

Product Candidates

 

The LB-100 series consists of novel structures which have the potential to be first in their class and may be useful in the treatment of not only several types of cancer but also vascular and metabolic diseases. The LB-200 series contains compounds which have the potential to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease, in addition to cancer and neurodegenerative diseases.

 

The Company has demonstrated that lead compounds of both the LB-100 series and the LB-200 are active against a broad spectrum of human cancers in cell culture and against several types of human cancers in animal models. The research on these compounds was initiated in 2006 under a Cooperative Research and Development Agreement, or CRADA, with the National Institute of Neurologic Disorders and Stroke, or NINDS, of the National Institutes of Health, or NIH, dated March 22, 2006 that was subsequently extended through a series of amendments until it terminated on April 1, 2013. As discussed below, the Company’s primary focus is on the clinical development of LB-100.

 

The LB-200 series consists of histone deacetylase inhibitors (HDACi). Many pharmaceutical companies are also developing drugs of this type, and at least two companies have HDACi approved for clinical use, in both cases for the treatment of a type of lymphoma. Despite this significant competition, the Company has demonstrated that its HDACi have broad activity against many cancer types, have neuroprotective activity, and have anti-fungal activity. In addition, these compounds have low toxicity. LB-200 has not yet advanced to the clinical stage and would require additional capital to fund further development. Accordingly, because of the Company’s focus on the clinical development of LB-100 and analogs for cancer therapy as described below in more detail, the Company has decided not to actively pursue the pre-clinical development of the LB-200 series of compounds. At this time, the Company intends to only maintain composition and synthesis patents on the LB-200 series of compounds in the United States.

 

Collaborations with leading academic research centers in the United States, Europe and Asia have established the breadth of activity of LB-100 in pre-clinical models of several major cancers. There is considerable scientific interest in LB-100 because it exerts its activity by a novel mechanism and is the first of its type to be evaluated so broadly in multiple animal models of cancer and now in human beings. LB-100 is one of a series of serine/threonine phosphatase (s/t ptase) inhibitors designed by the Company. The s/t ptases are ubiquitous enzymes that regulate many cell signaling networks important to cell growth, division and death. The s/t ptases have long been appreciated as potentially important targets for anti-cancer drugs. However, because of the multi- functionality of these enzymes, it had been widely held that pharmacologic inhibitors of s/t ptases would be too toxic to allow their development as anti-cancer treatments, but the Company has shown that this is not the case. LB-100 was well tolerated at doses associated with objective regression (significant tumor shrinkage) and/or the arresting of tumor progression in patients with progressive cancers.

 

Pre-clinical studies showed that LB-100 itself inhibits a spectrum of human cancers and that combined with standard cytotoxic drugs and/or radiation, LB-100 potentiates their effectiveness against hematologic and solid tumor cancers without enhancing toxicity. Given at very low doses in animal models of cancer, LB-100 markedly increased the effectiveness of a PD-1 blocker, one of the widely used new immunotherapy drugs. This finding raises the possibility that LB-100 may further expand the value of the expanding field of cancer immunotherapy.

 

The Company completed a Phase 1 clinical trial of LB-100 to evaluate its safety that showed it is associated with antitumor activity in humans at doses that are readily tolerable. Responses included objective regression (tumor shrinkage) lasting for 11 months of a pancreatic cancer and cessation of growth (stabilization of disease) for 4 months or more of 9 other progressive solid tumors out of 20 patients who had measurable disease. As Phase 1 clinical trials are fundamentally designed to determine safety of a new compound in humans, the Company was encouraged by these results. The next step is to demonstrate in Phase 2 clinical trials the efficacy of LB-100 in one or more specific tumor types, against which the compound has well documented activity in pre-clinical models.

 

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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 expand the breadth and depth of 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.

 

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. 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 Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its 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 (including, specifically, clinical trial 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 are various indications that the United States economy may be entering a recessionary period. Although unclear at this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn, affect the Company.

 

The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available.

 

Results of Operations

 

At June 30, 2023, 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     Six Months Ended  
    June 30,     June 30,  
    2023     2022     2023     2022  
                         
Revenues   $     $     $     $  
                                 
Costs and expenses:                                
General and administrative costs:                                
Compensation to related parties     522,561       753,530       1,042,041       1,319,452  
Patent and licensing legal and filing fees and costs     340,010       358,389       657,350       673,626  
Other costs and expenses     379,970       269,281       724,212       584,023  
Research and development costs     427,457       164,810       616,542       623,261  
Total costs and expenses     1,669,998       1,546,010       3,040,145       3,200,362  
Loss from operations     (1,669,998 )     (1,546,010 )     (3,040,145 )     (3,200,362 )
Interest income     2,714       191       7,729       300  
Interest expense     (1,948 )     (627 )     (5,809 )     (3,121 )
Foreign currency gain (loss)     877       142       2,211       (39 )
Net loss   $ (1,668,355 )   $ (1,546,304 )   $ (3,036,014 )   $ (3,203,222 )
                                 
Net loss per common share – basic and diluted   $ (1.00 )   $ (0.95 )   $ (1.82 )   $ (2.14 )
                                 
Weighted average common shares outstanding – basic and diluted     1,665,956       1,620,091       1,665,479       1,498,076  

 

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Three Months Ended June 30, 2023 and 2022

 

Revenues. The Company did not have any revenues for the three months ended June 30, 2023 and 2022.

 

General and Administrative Costs. For the three months ended June 30, 2023, general and administrative costs were $1,242,541, which consisted of the fair value of vested stock options issued to directors and officers of $280,060, patent and licensing legal and filing fees and costs of $340,010, other consulting and professional fees of $159,361, insurance expense of $104,151, officer salaries and related costs of $216,248, cash-based director and board committee fees of $42,501, licensing fees of $6,233, shareholder reporting costs of $57,350, listing fees of $15,500, filing fees of $3,470, taxes and licenses of $3,769, investor relations of $9,372, and other operating costs of $4,516.

 

For the three months ended June 30, 2022, general and administrative costs were $1,381,200, which consisted of the fair value of vested stock options issued to directors and officers of $424,094, patent and licensing legal and filing fees and costs of $358,389, other consulting and professional fees of $97,740, insurance expense of $117,135, officer salaries and related costs of $209,622, cash-based director and board committee fees of $135,686, licensing fees of $6,233, shareholder reporting costs of $3,370, listing fees of $14,875, filing fees of $3,088, taxes and licenses of $4,069, investor relations of $2,452, and other operating costs of $7,447.

 

General and administrative costs decreased by $138,659, or 10.0%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $144,034, a decrease in patent and licensing legal and filing fees and costs of $18,379, a decrease in cash-based director and board committee fees of $93,185, offset by increases in other consulting and professional fees of $61,621 and an increase in transfer agent and other shareholder reporting costs of $53,980.

 

Research and Development Costs. For the three months ended June 30, 2023, research and development costs were $427,457, which consisted of clinical and related oversight costs of $297,763, regulatory service costs of $1,740, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $127,954.

 

For the three months ended June 30, 2022, research and development costs were $164,810, which consisted of contractor costs incurred in connection with the synthesis work done to develop a new supply of LB-100 for the Spanish clinical trial of $18,774, clinical and related oversight costs of $21,865, regulatory service costs of $360, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $123,811.

 

Included in pre-clinical research costs for the three months ended June 30, 2023 and 2022 were $53,178 and $48,886, respectively, of costs paid to the Netherlands Cancer Institute, which employs Dr. René Bernards, a director of the Company since June 15, 2022. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, 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 (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute” below).

 

Research and development costs increased by $262,647, or 159.4%, in 2023 as compared to 2022, primarily as a result of an increase in clinical and related oversight costs of $275,898.

 

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Interest Income. For the three months ended June 30, 2023, the Company had interest income of $2,714, as compared to interest income of $191 for the three months ended June 30, 2022, related to the investment of funds generated by the Company’s financing activities.

 

Interest Expense. For the three months ended June 30, 2023, the Company had interest expense of $1,948, as compared to interest expense of $627 for the three months ended June 30, 2022, related to the financing of the premium for the Company’s directors and officers liability insurance policy.

 

Foreign Currency Loss. For the three months ended June 30, 2023, the Company had a foreign currency gain of $877, as compared to a foreign currency gain of $142 for the three months ended June 30, 2022, from foreign currency transactions.

 

Net Loss. For the three months ended June 30, 2023, the Company incurred a net loss of $1,668,355, as compared to a net loss of $1,546,304 for the three months ended June 30, 2022.

 

Six Months Ended June 30, 2023 and 2022

 

Revenues. The Company did not have any revenues for the six months ended June 30, 2023 and 2022.

 

General and Administrative Costs. For the six months ended June 30, 2023, general and administrative costs were $2,423,603, which consisted of the fair value of vested stock options issued to directors and officers of $557,040, patent and licensing legal and filing fees and costs of $657,350, other consulting and professional fees of $329,946, insurance expense of $208,305, officer salaries and related costs of $432,603, cash-based director and board committee fees of $85,001, licensing fees of $12,398, shareholder reporting costs of $60,896, listing fees of $31,000, filing fees of $10,195, taxes and licenses of $7,538, investor relations of $22,344, and other operating costs of $8,987.

 

For the six months ended June 30, 2022, general and administrative costs were $2,577,101, which consisted of the fair value of vested stock options issued to directors and officers of $763,766, patent and licensing legal and filing fees and costs of $673,626, other consulting and professional fees of $235,455, insurance expense of $234,270, officer salaries and related costs of $420,489, cash-based director and board committee fees of $168,186, licensing fees of $12,398, shareholder reporting costs of $6,324, listing fees of $29,750, filing fees of $8,412, taxes and licenses of $8,138, investor relations of $4,849, and other operating costs of $11,438.

 

General and administrative costs decreased by $153,498, or 6.0%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $206,726, a decrease in patent and licensing legal and filing fees and costs of $16,276, a decrease in cash-based director and board committee fees of $83,185, offset by increases in other consulting and professional fees of $94,491 and an increase in transfer agent and other shareholder reporting costs of $54,572.

 

Research and Development Costs. For the six months ended June 30, 2023, research and development costs were $616,542, which consisted of clinical and related oversight costs of $393,892, regulatory service costs of $7,819, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $214,831.

 

For the six months ended June 30, 2022, research and development costs were $623,261, which consisted of contractor costs incurred in connection with the synthesis work done to develop a new supply of LB-100 for the Spanish clinical trial of $351,488, clinical and related oversight costs of $32,978, regulatory service costs of $360, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $238,435.

 

Included in pre-clinical research costs for the six months ended June 30, 2023 and 2022 were $105,382 and $103,116, respectively, of costs paid