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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the transition period from _______________to _______________

 

Commission file number 001-13467

 

Inhibitor Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   30-0793665

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

     

4905 South West Shore Blvd

Tampa, FL

  33611-3329
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number (including area code):

813-864-2562

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

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, or a non-accelerated filer or a smaller reporting company. See definition 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 11, 2023, there were 171,998,545 shares of company common stock issued and outstanding.

 

 

 

 

 

 

Inhibitor Therapeutics, Inc.

Quarterly Report on Form 10-Q

TABLE OF CONTENTS

 

    Page
     
Part I. Financial Information  
     
Item 1. Condensed Financial Statements (unaudited)  
     
  Condensed Balance Sheets as of June 30, 2023 and December 31, 2022 1
     
  Condensed Statements of Operations for the three and six months ended June 30, 2023 and 2022 2
     
  Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022 3
     
  Condensed Statements of Cash Flows for the six months ended June 30, 2023 and 2022 4
     
  Notes to Condensed Financial Statements 5
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 8
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 9
     
Item 4. Controls and Procedures 9
     
Cautionary Note on Forward Looking Statements 10
   
Part II. Other Information  
     
Item 1 Legal Proceedings 11
     
Item 1A. Risk Factors 11
     
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 11
     
Item 3 Defaults upon Senior Securities 12
     
Item 4 Mine Safety Disclosures 11
     
Item 5 Other Information 11
     
Item 6. Exhibits 12
     
Signatures 13

 

 

 

 

INHIBITOR THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

AS OF JUNE 30, 2023 AND DECEMBER 31, 2022

 

   (Unaudited)
June 30, 2023
   December 31, 2022 
ASSETS          
Current assets:          
Cash and cash equivalents  $10,100,327   $11,951,224 
Prepaid expenses   58,007    23,900 
Total current assets   10,158,334    11,975,124 
Total assets  $10,158,334   $11,975,124 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $11,750   $145,161 
Notes payable, related party       411,000 
Accrued expenses and other liabilities   32,109    122,621 
Total current liabilities   43,859    678,782 
Deferred revenue   3,000,000    3,000,000 
Total liabilities   3,043,859    3,678,782 
Commitments and contingencies (note 5)        
Stockholders’ equity:          
Series A Preferred Stock, $0.0001 par value; 500,000 shares authorized; no shares issued and outstanding at June 30, 2023 and December 31, 2022        
Series B Convertible, Redeemable, Preferred Stock, $0.0001 par value; 7,246,377 shares authorized; no shares issued and outstanding at June 30, 2023 and December 31, 2022        
Undesignated Preferred Stock, $0.0001 par value; 2,253,623 shares authorized; no shares issued or outstanding at June 30, 2023 and December 31, 2022        
Common stock, $0.0001 par value; 500,000,000 shares authorized; 171,968,134 and 171,793,134 shares issued and outstanding at June 30, 2023 and December 31, 2022   17,197    17,179 
Additional paid-in capital   54,045,316    54,033,084 
Accumulated deficit   (46,948,038)   (45,753,921)
Total stockholders’ equity   7,114,475    8,296,342 
Total liabilities and stockholders’ equity  $10,158,334   $11,975,124 

 

See notes to condensed financial statements

 

1

 

 

INHIBITOR THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

FOR THE THREE-MONTH AND SIX-MONTH PERIODS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

   2023   2022   2023   2022 
   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2023   2022   2023   2022 
Revenues:  $   $   $   $ 
Expenses:                    
Research and development   233,993    6,150    435,391    6,150 
General and administrative   508,468    64,654    936,794    158,154 
Total expenses   742,461    70,804    1,372,185    164,304 
Loss from operations   (742,461)   (70,804)   (1,372,185)   (164,304)
                     
Other income / (expenses):                    
Interest expense, related party       (6,763)       (12,173)
Interest income   87,940        178,068     
Net loss   (654,521)   (77,567)   (1,194,117)   (176,477)
Preferred stock dividend       (49,863)       (99,178)
Net loss applicable to common stockholders  $(654,521)  $(127,430)  $(1,194,117)  $(275,655)
Basic and diluted net loss applicable to common stockholders per share  $(0.00)  $(0.00)  $(0.01)  $(0.00)
Weighted average common stock shares outstanding – basic and diluted   171,968,134    376,858,323    171,881,117    376,858,323 

 

See notes to condensed financial statements

 

2

 

 

INHIBITOR THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

   Shares   Amount   Shares   Amount   Capital   Deficit   Equity 
   Preferred
Stock– Series B
   Common Stock   Additional
Paid-In
   Accumulated   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2023      $    171,793,134   $17,179   $54,033,084   $(45,753,921)  $8,296,342 
Net loss                       (539,596)   (539,596)
Balances, March 31, 2023      $    171,793,134   $17,179   $54,033,084   $(46,293,517)  $7,756,746 
Issuance of common stock under equity incentive plan           175,000    18    12,232        12,250 
Net loss                       (654,521)   (654,521)
Balances, June 30, 2023      $    171,968,134   $17,197   $54,045,316   $(46,948,038)  $7,114,475 

 

   Preferred
Stock– Series B
   Common Stock   Additional
Paid-In
   Accumulated   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2022   5,797,102   $3,960,866    376,858,323   $37,686   $50,051,711   $(57,671,109)  $(3,620,846)
Preferred stock dividends, related party                       (49,315)   (49,315)
Net loss                       (98,910)   (98,910)
Balances, March 31, 2022   5,797,102   $3,960,866    376,858,323   $37,686   $50,051,711   $(57,819,334)  $(3,769,071)
Preferred stock dividends, related party                       (49,863)   (49,863)
Net loss                       (77,567)   (77,567)
Balances, June 30, 2022   5,797,102   $3,960,866    376,858,323   $37,686   $50,051,711   $(57,946,764)  $(3,896,501)

 

See notes to condensed financial statements

 

3

 

 

INHIBITOR THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

   2023   2022 
   Six Months Ended June 30, 
   2023   2022 
Operating activities:          
Net loss  $(1,194,117)  $(176,477)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock based compensation   12,250    

 
Changes in assets and liabilities:          
Prepaid expenses   (34,107)   14,586 
Accounts payable and other current liabilities   (223,923)   56,210 
Net cash used in operating activities   (1,439,897)   (105,681)
Financing activities:          
Proceeds from notes payable, related party       100,000 
Payments made on notes payable, related party   (411,000)    
Net cash (used in) provided by financing activities   (411,000)   100,000 
Net change in cash and cash equivalents   (1,850,897)   (5,681)
Cash and cash equivalents at beginning of period   11,951,224    30,626 
Cash and cash equivalents at end of period  $10,100,327   $24,945 
Non-cash financing activities:          
Accrued, but unpaid dividends  $   $99,178 

 

See notes to condensed financial statements

 

4

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

1. Corporate overview:

 

Overview

 

The accompanying unaudited condensed financial statements of Inhibitor Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar terminology), have been prepared by the Company without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows as of June 30, 2023, and for all periods presented, have been made.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on March 31, 2023 (the “2022 Annual Report”). The accompanying condensed balance sheet as of December 31, 2022 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial statements.

 

As used herein, the term “Common Stock” means the Company’s common stock, $0.0001 par value per share.

 

The results of operations for the three-month and six-month period ended June 30, 2023, are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors relating to the Company which are set forth in the 2022 Annual Report and the Company’s other filings with the SEC.

 

Nature of the Business and Background

 

The Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. The Company has explored and expects to continue to explore acquiring or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based on repurposing active ingredients of already approved drugs.

 

The Company’s current primary focus is on the development of therapies initially for basal cell carcinoma, prostate and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S. Food and Drug Administration (“FDA”) to treat fungal infections, and which has an extensive history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. In particular, the Company is negotiating with Johns Hopkins University to license US Patent 8,890,930 B2 which deals with methods of inhibiting angiogenesis, and treating or preventing a disease or disorder (or symptoms thereof) associated with angiogenesis such as cancers like basal cell carcinomas.

 

Following the resolution of the litigation involving the Company in December 2022 and the resulting settlement agreement, the new Board and management of the Company intend to continue the development of itraconazole for BCCNS, and other cancers and non-cancerous proliferative disorders. To that end, the development or acquisition of its own proprietary and patent-protected formulation of itraconazole is anticipated. In addition, the Company is exploring the addition of other product candidates that meet our strict criteria: products that target an unmet medical need of significant clinical value, and are patent protected, and that qualify for the 505(b)2 regulatory pathway.

 

5

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

2. Summary of Significant Accounting Policies:

 

Estimates

 

The preparation of condensed financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company currently has no ongoing source of revenues. Miscellaneous income, including interest, is recognized when earned by the Company. Deferred revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue would be classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue will be recognized when the product is sold and the royalty is earned. All deferred revenue is related to a basal cell carcinoma nevus syndrome (BCCNS) product which is yet to be approved by FDA, and as a result the Company has determined that 100% of the advances of the royalty received should be classified as non-current. At June 30, 2023 and December 31, 2022, deferred revenue consisted of $3.0 million of royalties advanced by Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”).

 

Cash and Cash Equivalents

 

Cash and cash equivalents include cash in bank accounts as well as investments in highly-liquid money market funds and sweep accounts with original maturities of three months or less. The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. At times, the Company may maintain cash balances in excess of Federal Deposit Insurance Corporation insured amounts. The Company continues to monitor the third-party depository institutions that hold the Company’s cash and limits its cash deposits to financial institutions with high credit standing.

 

Research and Development Expenses

 

Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties who conduct research and development activities on behalf of the Company.

 

Stock-Based Compensation

 

The Company accounts for stock-based awards to employees and non-employees using Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718 – Accounting for Share-Based Payments, which provides for the use of the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock on the date of grant. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using the “simplified method” which computes the expected term as the average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield. During the six months ended June 30, 2023, we granted 175,000 shares of restricted common stock that are restricted as to trading for a period of one year from the date of grant. No stock-based awards were issued during the six months ended June 30, 2022.

 

6

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

2. Summary of Significant Accounting Policies (continued):

 

Income Taxes

 

Deferred tax assets and liabilities are recognized for future tax consequences attributed to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected to apply to the differences in the periods that they are expected to reverse. Management has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain income tax positions that could have a significant effect on the financial statements as of June 30, 2023.

 

Recent accounting pronouncements:

 

Management has considered all recent accounting pronouncements issued, but not effective, and does not believe that any will have a material impact on the Company’s financial statements.

 

3. Notes payable, related party

 

The balance outstanding on the notes payable, related party at December 31, 2022 was $411,000 and was repaid in February 2023.

 

4. Stockholders’ Equity:

 

Employee Stock Plans

 

During the six months ended June 30, 2023, we granted 175,000 restricted common shares with an aggregate grant date fair value of approximately $0.01 million to the members of our Board of Directors under the equity incentive plan. The common shares are fully vested upon issuance and are restricted as to trading for a period of one year from the date of grant.

 

There was no stock-based compensation for the six months ended June 30, 2022. As of June 30, 2023, there were 2,575,646 outstanding common stock options under the Company’s equity incentive plan of which 100% were vested. There was no unamortized stock-based compensation at June 30, 2023. The weighted-average remaining contractual life and weighted-average exercise price per share as of June 30, 2023 were 6.3 years and $0.09, respectively. The common stock options had no intrinsic value as of June 30, 2023.

 

5. Legal Proceedings:

 

The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. The Company is not currently the subject of any pending legal proceedings.

 

7

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.

 

As used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms “the Company”, “we”, “us”, “our” and similar terminology refer to Inhibitor Therapeutics, Inc.

 

Background of the Company

 

We are a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. We also have explored and expect to continue to explore acquiring or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based on repurposing active ingredients of already approved drugs.

 

Our current primary focus is on the development of therapies initially for basal cell carcinoma, prostate and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S. Food and Drug Administration (“FDA”) to treat fungal infections, and which has an extensive history of safe and effective use in humans. The Company has developed, intellectual property and know-how related to the treatment of cancer patients using itraconazole. In particular, the Company is negotiating with Johns Hopkins University to license US Patent 8,890,930 B2 which deals with methods of inhibiting angiogenesis, and treating or preventing a disease or disorder (or symptoms thereof) associated with angiogenesis such as cancers like basal cell carcinomas.

 

Following the resolution of the litigation involving the Company in December 2022 and the resulting settlement agreement, the new Board and management of the Company intend to continue the development of itraconazole for BCCNS, and other cancers and non-cancerous proliferative disorders. To that end, the development or acquisition of its own proprietary and patent-protected formulation of itraconazole is anticipated. In addition, the Company is exploring the addition of other product candidates that meet our strict criteria: products that target an unmet medical need of significant clinical value, and are patent protected, and that qualify for the 505(b)2 regulatory pathway.

 

Critical Accounting Policies

 

See Note 2 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting policies and information on recently issued accounting pronouncements.

 

Results of Operations

 

For the three months ended June 30, 2023 compared to the three months ended June 30, 2022

 

Research and Development Expenses. We recognized approximately $0.2 million in research and development expenses during the three months ended June 30, 2023. The expenses are primarily patent-related expenses and personnel costs relating to research and development activities. We recognized less than $0.01 million in research and development expenses during the three months ended June 30, 2022, relating to minimal costs incurred relating to patents.

 

General and Administrative Expenses. We recognized approximately $0.5 million and $0.1 million in general and administrative expenses during the three months ended June 30, 2023 and June 30, 2022, respectively. General and administrative expenses are composed primarily of compensation, insurance, professional fees and other related costs. The increase of approximately $0.4 million is due primarily to the increase in overhead costs incurred as a result of the governance and management transitions related to litigation that resolved in December 2022.

 

8

 

 

Interest expense. We recognized approximately $0.01 million in interest expense during the three months ended June 30, 2022 associated with the outstanding balance on the Mayne Term Debt Facility during the period. There was no such interest incurred during the same period in 2023.

 

Interest income. We recognized approximately $0.1 million interest income during the three months ended June 30, 2023. The interest income was generated from the proceeds resulting from the legal settlement received by the Company in December 2022 which earned interest within the Company’s depository accounts during the period. There was no such income recorded during the same period in 2022.

 

For the six months ended June 30, 2023 compared to the six months ended June 30, 2022

 

Research and Development Expenses. We recognized approximately $0.4 million in research and development expenses during the six months ended June 30, 2023. The expenses are primarily patent-related expenses and personnel costs relating to research and development activities. We recognized less than $0.01 million in research and development expenses during the six months ended June 30, 2022, relating to minimal costs incurred relating to patents.

 

General and Administrative Expenses. We recognized approximately $0.9 million and $0.2 million in general and administrative expenses during the six months ended June 30, 2023 and June 30, 2022, respectively. General and administrative expenses are composed primarily of compensation, insurance, professional fees and other related costs. The increase of approximately $0.7 million is due primarily to the increase in overhead costs incurred as a result of the governance and management transitions related to litigation that resolved in December 2022.

 

Interest expense. We recognized approximately $0.01 million in interest expense during the six months ended June 30, 2022 associated with the outstanding balance on the Mayne Term Debt Facility during the period. There was no such interest incurred during the same period in 2023.

 

Interest income. We recognized approximately $0.2 million interest income during the six months ended June 30, 2023. The interest income was generated from the proceeds resulting from the legal settlement received by the Company in December 2022 which earned interest within the Company’s depository accounts during the period. There was no such income recorded during the same period in 2022.

 

Liquidity and Capital Resources

 

We are presently developing and conducting our business plan and are exploring the potential acquisition or license of additional product candidates. Based on our current operational plan and budget, we expect that we will have sufficient cash to manage our business as now contemplated for more than 12 months. As we determine capital requirements for existing and new opportunities, we will consider raising additional capital in the public market.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

None.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this Quarterly Report, the Company’s management, with the participation of the Company’s Chief Executive Officer and Interim Chief Financial Officer (the “Certifying Officers”), conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a–15I and 15d–15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.

 

9

 

 

Based on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during our second fiscal quarter of 2023 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on the Effectiveness of Internal Controls

 

Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

 

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

 

Certain information set forth in this Quarterly Report on Form 10-Q, including in Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” (and the “Liquidity and Capital Resources” section thereof) and elsewhere may address or relate to future events and expectations and as such constitutes “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects”, “may”, “could”, “would”, “should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. These statements are based upon the current beliefs and expectations of our management and are subject to significant risks and uncertainties, including those detailed in our filings with the SEC. Actual results, including, without limitation: (i) our ability to develop and ultimately commercialize therapeutics, or (ii) the application and availability of corporate funds and our need for future funds. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Such factors include, among others,

 

  acceptance of our business model by investors and potential commercial collaborators;
     
  our future capital requirements and our ability to satisfy our capital needs;
     
  our ability to commence and complete required clinical trials of product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions;
     
  our ability to secure and maintain key development and commercialization partners for our product candidate;
     
  our ability to obtain, maintain or protect the validity of our owned or licensed patents and other intellectual property;
     
  our ability to internally develop, acquire or license new inventions and intellectual property;
     
  our ability to retain key executive members;
     
  interpretations of current laws and the passages of future laws, rules and regulations applicable to our business; and
     
  those risk factors listed under Item 1A of our 2022 Annual Report and other factors detailed from time to time in our other filings with the SEC.

 

Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

10

 

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. The Company is not currently the subject of any pending legal proceedings.

 

Item 1A. Risk Factors.

 

Not required for smaller reporting companies.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 

Item 3. Defaults upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

Not applicable.

 

11

 

 

Item 6. Exhibits.

 

Number   Description
     
31.1   Certification of Chief Executive Officer Pursuant to Sarbanes-Oxley Section 302
     
31.2   Certification of Interim Chief Financial Officer Pursuant to Sarbanes-Oxley Section 302
     
32.1   Certification Pursuant To 18 U.S.C. Section 1350 (*)
     
32.2   Certification Pursuant To 18 U.S.C. Section 1350 (*)
     
101.ins   Inline XBRL Instance Document
     
101.sch   Inline XBRL Taxonomy Extension Schema Document
     
101.cal   Inline XBRL Taxonomy Calculation Linkbase Document
     
101.def   Inline XBRL Taxonomy Definition Linkbase Document
     
101.lab   Inline XBRL Taxonomy Label Linkbase Document
     
101.pre   Inline XBRL Taxonomy Presentation Linkbase Document
     
104   The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, formatted in Inline XBRL.
     
*   A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

12

 

 

SIGNATURES

 

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  INHIBITOR THERAPEUTICS, INC.
     
Date: August 11, 2023 By: /s/ Francis E. O’Donnell
   

Francis E. O’Donnell

Chief Executive Officer

(Principal Executive Officer)

     
Date: August 11, 2023 By: /s/ James A. McNulty
   

James A. McNulty

Interim Chief Financial Officer, Treasurer and Secretary

(Principal Financial Officer)

 

13

 

 

Exhibit 31.1

 

Certification of Chief Executive Officer

Pursuant to Rule 13a-14(a)

 

I, Francis E. O’Donnell, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Inhibitor Therapeutics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries as applicable, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 11, 2023

 

/s/ Francis E. O’Donnell  
Francis E. O’Donnell  
Chief Executive Officer  

 

 

 

 

Exhibit 31.2

 

Certification of Interim Chief Financial Officer

Pursuant to Rule 13a-14(a)

 

I, James A. McNulty, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Inhibitor Therapeutics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries as applicable, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 11, 2023

 

/s/ James A. McNulty  
James A. McNulty  
Interim Chief Financial Officer, Treasurer and Secretary  

 

 

 

 

Exhibit 32.1

 

INHIBITOR THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Inhibitor Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Francis E. O’Donnell, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

/s/ Francis E. O’Donnell  
Francis E. O’Donnell  
Chief Executive Officer  
August 11, 2023  

 

 

 

 

Exhibit 32.2

 

INHIBITOR THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Inhibitor Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James A. McNulty, Interim Chief Financial Officer, Treasurer and Secretary of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

/s/ James A. McNulty  
James A. McNulty  
Interim Chief Financial Officer, Treasurer and Secretary  
August 11, 2023  

 

 

 

v3.23.2
Cover - shares
6 Months Ended
Jun. 30, 2023
Aug. 11, 2023
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2023  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2023  
Current Fiscal Year End Date --12-31  
Entity File Number 001-13467  
Entity Registrant Name Inhibitor Therapeutics, Inc.  
Entity Central Index Key 0001042418  
Entity Tax Identification Number 30-0793665  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 4905 South West Shore Blvd  
Entity Address, City or Town Tampa  
Entity Address, State or Province FL  
Entity Address, Postal Zip Code 33611-3329  
City Area Code 813  
Local Phone Number 864-2562  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   171,998,545
v3.23.2
Condensed Balance Sheets - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Current assets:    
Cash and cash equivalents $ 10,100,327 $ 11,951,224
Prepaid expenses 58,007 23,900
Total current assets 10,158,334 11,975,124
Total assets 10,158,334 11,975,124
Current liabilities:    
Accounts payable 11,750 145,161
Notes payable, related party $ 411,000
Notes Payable, Current, Related Party, Type [Extensible Enumeration]   Related Party [Member]
Accrued expenses and other liabilities 32,109 $ 122,621
Total current liabilities 43,859 678,782
Deferred revenue 3,000,000 3,000,000
Total liabilities 3,043,859 3,678,782
Commitments and contingencies (note 5)
Stockholders’ equity:    
Common stock, $0.0001 par value; 500,000,000 shares authorized; 171,968,134 and 171,793,134 shares issued and outstanding at June 30, 2023 and December 31, 2022 17,197 17,179
Additional paid-in capital 54,045,316 54,033,084
Accumulated deficit (46,948,038) (45,753,921)
Total stockholders’ equity 7,114,475 8,296,342
Total liabilities and stockholders’ equity 10,158,334 11,975,124
Series A Preferred Stock [Member]    
Stockholders’ equity:    
Preferred stock, value
Series B Convertible Preferred Stock [Member]    
Stockholders’ equity:    
Preferred stock, value
Undesignated Preferred Stock [Member]    
Stockholders’ equity:    
Preferred stock, value
v3.23.2
Condensed Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 500,000,000 500,000,000
Common stock, shares issued 171,968,134 171,793,134
Common stock, shares outstanding 171,968,134 171,793,134
Series A Preferred Stock [Member]    
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 500,000 500,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Series B Convertible Preferred Stock [Member]    
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 7,246,377 7,246,377
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Undesignated Preferred Stock [Member]    
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 2,253,623 2,253,623
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
v3.23.2
Condensed Statements of Operations (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Income Statement [Abstract]        
Revenues:
Expenses:        
Research and development 233,993 6,150 435,391 6,150
General and administrative 508,468 64,654 936,794 158,154
Total expenses 742,461 70,804 1,372,185 164,304
Loss from operations (742,461) (70,804) (1,372,185) (164,304)
Other income / (expenses):        
Interest expense, related party $ (6,763) $ (12,173)
Interest Expense, Related Party, Type [Extensible Enumeration]   Related Party [Member]   Related Party [Member]
Interest income 87,940 178,068
Net loss (654,521) (77,567) (1,194,117) (176,477)
Preferred stock dividend (49,863) (99,178)
Net loss applicable to common stockholders $ (654,521) $ (127,430) $ (1,194,117) $ (275,655)
Earnings per share basic $ (0.00) $ (0.00) $ (0.01) $ (0.00)
Earnings per share diluted $ (0.00) $ (0.00) $ (0.01) $ (0.00)
Weighted average number of shares outstanding basic 171,968,134 376,858,323 171,881,117 376,858,323
Weighted average number of shares outstanding diluted 171,968,134 376,858,323 171,881,117 376,858,323
v3.23.2
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($)
Series B Convertible Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Beginning balance, value at Dec. 31, 2021 $ 3,960,866 $ 37,686 $ 50,051,711 $ (57,671,109) $ (3,620,846)
Beginning balance, shares at Dec. 31, 2021 5,797,102 376,858,323      
Net loss (98,910) (98,910)
Preferred stock dividends, related party (49,315) (49,315)
Ending balance, value at Mar. 31, 2022 $ 3,960,866 $ 37,686 50,051,711 (57,819,334) (3,769,071)
Ending balance, shares at Mar. 31, 2022 5,797,102 376,858,323      
Beginning balance, value at Dec. 31, 2021 $ 3,960,866 $ 37,686 50,051,711 (57,671,109) (3,620,846)
Beginning balance, shares at Dec. 31, 2021 5,797,102 376,858,323      
Net loss         (176,477)
Ending balance, value at Jun. 30, 2022 $ 3,960,866 $ 37,686 50,051,711 (57,946,764) (3,896,501)
Ending balance, shares at Jun. 30, 2022 5,797,102 376,858,323      
Beginning balance, value at Mar. 31, 2022 $ 3,960,866 $ 37,686 50,051,711 (57,819,334) (3,769,071)
Beginning balance, shares at Mar. 31, 2022 5,797,102 376,858,323      
Net loss (77,567) (77,567)
Preferred stock dividends, related party (49,863) (49,863)
Ending balance, value at Jun. 30, 2022 $ 3,960,866 $ 37,686 50,051,711 (57,946,764) (3,896,501)
Ending balance, shares at Jun. 30, 2022 5,797,102 376,858,323      
Beginning balance, value at Dec. 31, 2022 $ 17,179 54,033,084 (45,753,921) 8,296,342
Beginning balance, shares at Dec. 31, 2022 171,793,134      
Net loss (539,596) (539,596)
Ending balance, value at Mar. 31, 2023 $ 17,179 54,033,084 (46,293,517) 7,756,746
Ending balance, shares at Mar. 31, 2023 171,793,134      
Beginning balance, value at Dec. 31, 2022 $ 17,179 54,033,084 (45,753,921) 8,296,342
Beginning balance, shares at Dec. 31, 2022 171,793,134      
Net loss         (1,194,117)
Ending balance, value at Jun. 30, 2023 $ 17,197 54,045,316 (46,948,038) 7,114,475
Ending balance, shares at Jun. 30, 2023 171,968,134      
Beginning balance, value at Mar. 31, 2023 $ 17,179 54,033,084 (46,293,517) 7,756,746
Beginning balance, shares at Mar. 31, 2023 171,793,134      
Net loss (654,521) (654,521)
Issuance of common stock under equity incentive plan $ 18 12,232 12,250
Issuance of common stock under equity incentive plan, shares   175,000      
Ending balance, value at Jun. 30, 2023 $ 17,197 $ 54,045,316 $ (46,948,038) $ 7,114,475
Ending balance, shares at Jun. 30, 2023 171,968,134      
v3.23.2
Condensed Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Operating activities:    
Net loss $ (1,194,117) $ (176,477)
Adjustments to reconcile net loss to net cash used in operating activities:    
Stock based compensation 12,250
Changes in assets and liabilities:    
Prepaid expenses (34,107) 14,586
Accounts payable and other current liabilities (223,923) 56,210
Net cash used in operating activities (1,439,897) (105,681)
Financing activities:    
Proceeds from notes payable, related party 100,000
Payments made on notes payable, related party (411,000)
Net cash (used in) provided by financing activities (411,000) 100,000
Net change in cash and cash equivalents (1,850,897) (5,681)
Cash and cash equivalents at beginning of period 11,951,224 30,626
Cash and cash equivalents at end of period 10,100,327 24,945
Non-cash financing activities:    
Accrued, but unpaid dividends $ 99,178
v3.23.2
Corporate overview
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Corporate overview

1. Corporate overview:

 

Overview

 

The accompanying unaudited condensed financial statements of Inhibitor Therapeutics, Inc., a Delaware corporation (the “Company”, “INTI”, “we”, “us” or similar terminology), have been prepared by the Company without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows as of June 30, 2023, and for all periods presented, have been made.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on March 31, 2023 (the “2022 Annual Report”). The accompanying condensed balance sheet as of December 31, 2022 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial statements.

 

As used herein, the term “Common Stock” means the Company’s common stock, $0.0001 par value per share.

 

The results of operations for the three-month and six-month period ended June 30, 2023, are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors relating to the Company which are set forth in the 2022 Annual Report and the Company’s other filings with the SEC.

 

Nature of the Business and Background

 

The Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. The Company has explored and expects to continue to explore acquiring or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based on repurposing active ingredients of already approved drugs.

 

The Company’s current primary focus is on the development of therapies initially for basal cell carcinoma, prostate and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S. Food and Drug Administration (“FDA”) to treat fungal infections, and which has an extensive history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. In particular, the Company is negotiating with Johns Hopkins University to license US Patent 8,890,930 B2 which deals with methods of inhibiting angiogenesis, and treating or preventing a disease or disorder (or symptoms thereof) associated with angiogenesis such as cancers like basal cell carcinomas.

 

Following the resolution of the litigation involving the Company in December 2022 and the resulting settlement agreement, the new Board and management of the Company intend to continue the development of itraconazole for BCCNS, and other cancers and non-cancerous proliferative disorders. To that end, the development or acquisition of its own proprietary and patent-protected formulation of itraconazole is anticipated. In addition, the Company is exploring the addition of other product candidates that meet our strict criteria: products that target an unmet medical need of significant clinical value, and are patent protected, and that qualify for the 505(b)2 regulatory pathway.

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

v3.23.2
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies:

 

Estimates

 

The preparation of condensed financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company currently has no ongoing source of revenues. Miscellaneous income, including interest, is recognized when earned by the Company. Deferred revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue would be classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue will be recognized when the product is sold and the royalty is earned. All deferred revenue is related to a basal cell carcinoma nevus syndrome (BCCNS) product which is yet to be approved by FDA, and as a result the Company has determined that 100% of the advances of the royalty received should be classified as non-current. At June 30, 2023 and December 31, 2022, deferred revenue consisted of $3.0 million of royalties advanced by Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”).

 

Cash and Cash Equivalents

 

Cash and cash equivalents include cash in bank accounts as well as investments in highly-liquid money market funds and sweep accounts with original maturities of three months or less. The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. At times, the Company may maintain cash balances in excess of Federal Deposit Insurance Corporation insured amounts. The Company continues to monitor the third-party depository institutions that hold the Company’s cash and limits its cash deposits to financial institutions with high credit standing.

 

Research and Development Expenses

 

Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties who conduct research and development activities on behalf of the Company.

 

Stock-Based Compensation

 

The Company accounts for stock-based awards to employees and non-employees using Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718 – Accounting for Share-Based Payments, which provides for the use of the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock on the date of grant. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using the “simplified method” which computes the expected term as the average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield. During the six months ended June 30, 2023, we granted 175,000 shares of restricted common stock that are restricted as to trading for a period of one year from the date of grant. No stock-based awards were issued during the six months ended June 30, 2022.

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

2. Summary of Significant Accounting Policies (continued):

 

Income Taxes

 

Deferred tax assets and liabilities are recognized for future tax consequences attributed to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected to apply to the differences in the periods that they are expected to reverse. Management has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain income tax positions that could have a significant effect on the financial statements as of June 30, 2023.

 

Recent accounting pronouncements:

 

Management has considered all recent accounting pronouncements issued, but not effective, and does not believe that any will have a material impact on the Company’s financial statements.

 

v3.23.2
Notes payable, related party
6 Months Ended
Jun. 30, 2023
Debt Disclosure [Abstract]  
Notes payable, related party

3. Notes payable, related party

 

The balance outstanding on the notes payable, related party at December 31, 2022 was $411,000 and was repaid in February 2023.

 

v3.23.2
Stockholders’ Equity
6 Months Ended
Jun. 30, 2023
Equity [Abstract]  
Stockholders’ Equity

4. Stockholders’ Equity:

 

Employee Stock Plans

 

During the six months ended June 30, 2023, we granted 175,000 restricted common shares with an aggregate grant date fair value of approximately $0.01 million to the members of our Board of Directors under the equity incentive plan. The common shares are fully vested upon issuance and are restricted as to trading for a period of one year from the date of grant.

 

There was no stock-based compensation for the six months ended June 30, 2022. As of June 30, 2023, there were 2,575,646 outstanding common stock options under the Company’s equity incentive plan of which 100% were vested. There was no unamortized stock-based compensation at June 30, 2023. The weighted-average remaining contractual life and weighted-average exercise price per share as of June 30, 2023 were 6.3 years and $0.09, respectively. The common stock options had no intrinsic value as of June 30, 2023.

 

v3.23.2
Legal Proceedings
6 Months Ended
Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]  
Legal Proceedings

5. Legal Proceedings:

 

The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. The Company is not currently the subject of any pending legal proceedings.

v3.23.2
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Estimates

Estimates

 

The preparation of condensed financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.

 

Revenue Recognition

Revenue Recognition

 

The Company currently has no ongoing source of revenues. Miscellaneous income, including interest, is recognized when earned by the Company. Deferred revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue would be classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue will be recognized when the product is sold and the royalty is earned. All deferred revenue is related to a basal cell carcinoma nevus syndrome (BCCNS) product which is yet to be approved by FDA, and as a result the Company has determined that 100% of the advances of the royalty received should be classified as non-current. At June 30, 2023 and December 31, 2022, deferred revenue consisted of $3.0 million of royalties advanced by Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”).

 

Cash and Cash Equivalents

Cash and Cash Equivalents

 

Cash and cash equivalents include cash in bank accounts as well as investments in highly-liquid money market funds and sweep accounts with original maturities of three months or less. The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. At times, the Company may maintain cash balances in excess of Federal Deposit Insurance Corporation insured amounts. The Company continues to monitor the third-party depository institutions that hold the Company’s cash and limits its cash deposits to financial institutions with high credit standing.

 

Research and Development Expenses

Research and Development Expenses

 

Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties who conduct research and development activities on behalf of the Company.

 

Stock-Based Compensation

Stock-Based Compensation

 

The Company accounts for stock-based awards to employees and non-employees using Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718 – Accounting for Share-Based Payments, which provides for the use of the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock on the date of grant. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using the “simplified method” which computes the expected term as the average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield. During the six months ended June 30, 2023, we granted 175,000 shares of restricted common stock that are restricted as to trading for a period of one year from the date of grant. No stock-based awards were issued during the six months ended June 30, 2022.

 

 

INHIBITOR THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

 

2. Summary of Significant Accounting Policies (continued):

 

Income Taxes

Income Taxes

 

Deferred tax assets and liabilities are recognized for future tax consequences attributed to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected to apply to the differences in the periods that they are expected to reverse. Management has evaluated the guidance relating to accounting for uncertainty in income taxes and has determined that the Company had no uncertain income tax positions that could have a significant effect on the financial statements as of June 30, 2023.

 

Recent accounting pronouncements

Recent accounting pronouncements:

 

Management has considered all recent accounting pronouncements issued, but not effective, and does not believe that any will have a material impact on the Company’s financial statements.

v3.23.2
Corporate overview (Details Narrative) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Accounting Policies [Abstract]    
Common stock, par value $ 0.0001 $ 0.0001
v3.23.2
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
$ in Millions
6 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Product Information [Line Items]    
Number of restricted common stock granted 175,000  
Royalty [Member]    
Product Information [Line Items]    
Deferred revenue $ 3.0 $ 3.0
Royalty [Member] | Mayne Pharma [Member]    
Product Information [Line Items]    
Ownership percent 100.00%  
v3.23.2
Notes payable, related party (Details Narrative) - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Notes payable current $ 411,000
Loan Agreement [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Notes payable current   $ 411,000
v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Share-Based Payment Arrangement, Noncash Expense $ 12,250
2014 Equity Incentive Plan [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Issuance of common stock under equity incentive plan, shares 175,000  
Grant date fair value $ 10,000.00  
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number 2,575,646  
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage 100.00%  
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount $ 0  
Options, weighted average remaining contractual life 6 years 3 months 18 days  
Options, weighted average exercise price per share $ 0.09  

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