UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(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, 2022
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period fromto
Commission file number
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.) | |
Tampa, FL | 33602-2173 | |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number (including area code):888-841-6811
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(§ (§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
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
As of August 12, 2022May 15, 2023, there were 376,858,323 shares of company common stock issued and outstanding.
Inhibitor Therapeutics, Inc.
Quarterly Report on Form
TABLE OF CONTENTS
Page | |||||||
Part I. Financial Information | |||||||
Item 1. | Condensed Financial Statements (unaudited) | ||||||
1 | |||||||
2 | |||||||
3 | |||||||
4 | |||||||
5 | |||||||
Item 2. | 8 | ||||||
Item 3. | 9 | ||||||
Item 4. | 9 | ||||||
10 | |||||||
Item 1 | 11 | ||||||
Item 1A. | 11 | ||||||
Item 2 | 11 | ||||||
Item 3 | 11 | ||||||
Item 4 | 11 | ||||||
Item 5 | 11 | ||||||
Item 6. | 12 | ||||||
13 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
AS OF JUNE 30, 2022MARCH 31, 2023 AND DECEMBER 31, 2021
(Unaudited) | ||||||||
June 30, 2022 | December 31, 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 24,945 | $ | 30,626 | ||||
Prepaid expenses | 13,572 | 28,158 | ||||||
Total current assets | 38,517 | 58,784 | ||||||
Total assets | $ | 38,517 | $ | 58,784 | ||||
LIABILITIES AND STOC K HOLDERS’ DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 311,878 | $ | 279,842 | ||||
Dividends payable, related party | 200,002 | 100,823 | ||||||
Notes payable, related party | 331,000 | 231,000 | ||||||
Interest payable, related party | 27,139 | 14,965 | ||||||
Other liabilities | 65,000 | 53,000 | ||||||
Total current liabilities | 935,019 | 679,630 | ||||||
Deferred revenue, related party | 3,000,000 | 3,000,000 | ||||||
Total liabilities | 3,935,019 | 3,679,630 | ||||||
Commitments and contingencies (note 7) | 0— | 0— | ||||||
Stockholders’ deficit: | ||||||||
Series A Preferred Stock, $0.0001 par value; 500,000 shares authorized; 0 shares issued and outstanding | — | — | ||||||
Series B Convertible, Redeemable, Preferred Stock, $0.0001 par value; 7,246,377 shares authorized; 5,797,102 shares issued and outstanding at June 30, 2022 and December 31, 2021 | 3,960,866 | 3,960,866 | ||||||
Undesignated Preferred Stock, $0.0001 par value; 2,253,623 shares authorized; 0 shares issued or outstanding | — | — | ||||||
Common stock, $0.0001 par value; 500,000,000 shares authorized; 376,858,323 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 37,686 | 37,686 | ||||||
Additional paid-in capital | 50,051,711 | 50,051,711 | ||||||
Accumulated deficit | (57,946,765 | ) | (57,671,109 | ) | ||||
Total stockholders’ deficit | (3,896,502 | ) | (3,620,846 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 38,517 | $ | 58,784 | ||||
(Unaudited) March 31, 2023 | December 31, 2022 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 10,782,941 | $ | 11,951,224 | ||||
Prepaid expenses | 52,248 | 23,900 | ||||||
Total current assets | 10,835,189 | 11,975,124 | ||||||
Total assets | $ | 10,835,189 | $ | 11,975,124 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,007 | $ | 145,161 | ||||
— | 411,000 | |||||||
Accrued expenses and other liabilities | 73,436 | 122,621 | ||||||
Total current liabilities | 78,443 | 678,782 | ||||||
Deferred revenue | 3,000,000 | 3,000,000 | ||||||
Total liabilities | 3,078,443 | 3,678,782 | ||||||
Commitments and contingencies (note 5) | — | — | ||||||
Stockholders’ equity: | ||||||||
Series A Preferred Stock, $ | par value; shares authorized; shares issued and outstanding at March 31, 2023 and December 31, 2022— | — | ||||||
Series B Convertible, Redeemable, Preferred Stock, $ | par value; shares authorized; shares issued and outstanding at March 31, 2023 and December 31, 2022— | — | ||||||
Undesignated Preferred Stock, $ | par value; shares authorized; shares issued or outstanding at March 31, 2023 and December 31, 2022— | — | ||||||
Preferred stock, value | — | — | ||||||
Common stock, $ | par value; shares authorized; shares issued and outstanding at March 31, 2023 and December 31, 202217,179 | 17,179 | ||||||
Additional paid-in capital | 54,033,084 | 54,033,084 | ||||||
Accumulated deficit | (46,293,517 | ) | (45,753,921 | ) | ||||
Total stockholders’ equity | 7,756,746 | 8,296,342 | ||||||
Total liabilities and stockholders’ equity | $ | 10,835,189 | $ | 11,975,124 |
See notes to condensed financial statements
1 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
FOR THE THREE-MONTH ANDSIX-MONTHJUNE 30,MARCH 31, 2023 AND 2022 AND 2021
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues: | $ | — | $ | — | $ | — | $ | — | ||||||||
Expenses: | ||||||||||||||||
Research and development | 6,150 | 950 | 6,150 | 4,830 | ||||||||||||
General and administrative | 64,654 | 61,685 | 158,154 | 225,558 | ||||||||||||
Total Expenses: | 70,804 | 62,635 | 164,304 | 230,388 | ||||||||||||
Loss from operations | (70,804 | ) | (62,635 | ) | (164,304 | ) | (230,388 | ) | ||||||||
Interest expense, related party | (6,763 | ) | (3,547 | ) | (12,173 | ) | (5,232 | ) | ||||||||
Gain on loan forgiveness | — | — | — | 41,600 | ||||||||||||
Net loss | (77,567 | ) | (66,182 | ) | (176,477 | ) | (194,020 | ) | ||||||||
Preferred stock dividend | (49,863 | ) | (49,863 | ) | (99,178 | ) | (99,178 | ) | ||||||||
Net loss applicable to common stockholders | $ | (127,430 | ) | $ | (116,045 | ) | $ | (275,655 | ) | $ | (293,198 | ) | ||||
Basic and diluted net loss applicable to common stockholders per share | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | ||||
Weighted average common stock shares outstanding – basic and diluted | 376,858,323 | 375,876,361 | 376,858,323 | 375,703,064 | ||||||||||||
2023 | 2022 | |||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Revenues: | $ | — | $ | — | ||||
Expenses: | ||||||||
Research and development | 201,398 | — | ||||||
General and administrative | 428,326 | 93,500 | ||||||
Total expenses | 629,724 | 93,500 | ||||||
Loss from operations | (629,724 | ) | (93,500 | ) | ||||
Other income / (expenses): | ||||||||
— | (5,410 | ) | ||||||
Interest income | 90,128 | — | ||||||
Net loss | (539,596 | ) | (98,910 | ) | ||||
Preferred stock dividend | — | (49,315 | ) | |||||
Net loss applicable to common stockholders | $ | (539,596 | ) | $ | (148,225 | ) | ||
Basic and diluted net loss applicable to common stockholders per share | $ | (0.00 | ) | $ | (0.00 | ) | ||
Weighted average common stock shares outstanding – basic and diluted | 171,793,134 | 376,858,323 |
See notes to condensed financial statements
2 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTSTATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE SIXTHREE MONTHS ENDED JUNE 30,MARCH 31, 2023 AND 2022 AND 2021
(Unaudited)
Preferred Stock – Series B | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders’ Deficit | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
Balances, 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 | $ | 37,868 | $ | 50,051,711 | $ | (57,819,334 | ) | $ | (3,769,071 | ) | ||||||||||||||
Preferred stock dividends, related party | — | — | — | — | — | (49,864 | ) | (49,864 | ) | |||||||||||||||||||
Net loss | — | — | — | — | — | (77,567 | ) | (77,567 | ) | |||||||||||||||||||
Balance, June 30, 2022 | 5,797,102 | $ | 3,960,866 | 376,858,323 | $ | 37,868 | $ | 50,051,711 | $ | (57,946,765 | ) | $ | (3,896,502 | ) | ||||||||||||||
Preferred Stock – Series B | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders’ Deficit | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
Balances, January 1, 2021 | 5,797,102 | $ | 3,960,866 | 373,635,873 | $ | 37,364 | $ | 49,814,043 | $ | (57,172,476 | ) | $ | (3,360,203 | ) | ||||||||||||||
Common shares issued in payment of Preferred Stock dividend, related party | — | — | 2,240,488 | 224 | 100,598 | — | 100,822 | |||||||||||||||||||||
Stock based compensation | — | — | — | — | 37,990 | — | 37,990 | |||||||||||||||||||||
Preferred stock dividends, related party | — | — | — | — | — | (49,315 | ) | (49,315 | ) | |||||||||||||||||||
Net loss | — | — | — | — | — | (127,838 | ) | (127,838 | ) | |||||||||||||||||||
Balances, March 31, 2021 | 5,797,102 | $ | 3,960,866 | 375,876,361 | $ | 37,588 | $ | 49,952,631 | $ | (57,349,629 | ) | $ | (3,398,544 | ) | ||||||||||||||
Preferred stock dividends, related party | — | — | — | — | — | (49,863 | ) | (49,863 | ) | |||||||||||||||||||
Net loss | — | — | — | — | — | (66,182 | ) | (66,182 | ) | |||||||||||||||||||
Balances, June 30, 2021 | 5,797,102 | $ | 3,960,866 | 375,876,361 | $ | 37,588 | $ | 49,952,631 | $ | (57,465,674 | ) | $ | (3,514,589 | ) | ||||||||||||||
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 |
Preferred Stock – Series B | Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||||||||
Balances, 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 | ) |
See notes to condensed financial statements
3 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE SIXTHREE MONTHS ENDED JUNE 30,MARCH 31, 2023 AND 2022 AND 2021
(Unaudited)
2023 | 2022 | |||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Operating activities: | ||||||||
Net loss | $ | (539,596 | ) | $ | (98,910 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Changes in assets and liabilities: | ||||||||
Prepaid expenses | (28,348 | ) | 3,453 | |||||
Accounts payable and other current liabilities | (189,339 | ) | 51,269 | |||||
Net cash used in operating activities | (757,283 | ) | (44,188 | ) | ||||
Financing activities: | ||||||||
Proceeds from notes payable, related party | — | 50,000 | ||||||
Payments made on notes payable, related party | (411,000 | ) | — | |||||
Net cash (used in) provided by financing activities | (411,000 | ) | 50,000 | |||||
Net change in cash and cash equivalents | (1,168,283 | ) | 5,812 | |||||
Cash and cash equivalents at beginning of period | 11,951,224 | 30,626 | ||||||
Cash and cash equivalents at end of period | $ | 10,782,941 | $ | 36,438 | ||||
Non-cash financing activities: | ||||||||
Accrued, but unpaid dividends | $ | — | $ | 49,315 |
See notes to condensed financial statements
Six Months Ended June 30, | ||||||||
2022 | 2021 | |||||||
Operating activities: | ||||||||
Net loss | $ | (176,477 | ) | $ | (194,020 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock based compensation | — | 37,990 | ||||||
Gain on loan forgiveness | — | (41,600 | ) | |||||
Changes in assets and liabilities: | ||||||||
Prepaid expense and other assets | 14,586 | 13,896 | ||||||
Accounts payable and other current liabilities | 56,210 | 26,391 | ||||||
Net cash used in operating activities | (105,681 | ) | (157,343 | ) | ||||
Financing activities: | ||||||||
Proceeds from note payable, related party | 100,000 | 176,000 | ||||||
Net cash provided by financing activities | 100,000 | 176,000 | ||||||
Net change in cash and cash equivalents | (5,681 | ) | 18,657 | |||||
Cash and cash equivalents at beginning of period | 30,626 | 75,059 | ||||||
Cash and cash equivalents at end of period | $ | 24,945 | $ | 93,716 | ||||
Non-cash financing activities: | ||||||||
Issuance of common stock for payment of Preferred Stock dividend | $ | — | $ | 100,822 | ||||
Accrued, but unpaid dividends | $ | 99,178 | $ | 99,178 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIXTHREE MONTHS ENDED JUNE 30,MARCH 31, 2023 AND 2022 AND 2021
(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, 2022,March 31, 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, 2021,2022, which are included in the Company’s Annual Report on Form2021,2022, which was filed with the SEC on March 30, 202231, 2023 (the “2020“2022 Annual Report”). The accompanying condensed balance sheet as of December 31, 20212022 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 andsix-monthJune 30, 2022March 31, 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 20212022 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 certainWhile the Company is not presently conducting research and development activities with respect to its currently in-licensed technologies and its own intellectual property as a result of pending litigations involving the Company (see Note 7), theThe Company has explored and expects to continue to explore acquiring or licensing other innovative preclinical and clinical stage therapeutics addressing unmet needs beyond cancer based on repurposing active ingredients of already approved drugs. While the Company is not presently conducting clinical research activities as a result of recently settled litigation, the Company expects to resume development of itraconazole for cancer indications and orphan indications beyond cancer.
The Company’s current primary focus (assuming normal operations are able to recommence) is expected to be on the development of therapies initially for basal cell carcinoma, prostate and lung cancer in the U.S. market utilizing SUBA-Itraconazole,itraconazole, a patented, oral formulation of the drug itraconazole currently approved by the U.S. Food and Drug Administration (“FDA”) and marketed as an anti-fungal,towhich the Company holds an exclusive U.S. license in the licensed field from the Company’s majority stockholder, Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”). SUBA-Itraconazole is currently licensed to the Company by Mayne Pharma on an exclusive basis in the United States in the field of certain cancers (prostate and lung cancer) and certainnon-cancerousproliferation disorders pursuant to the Third Amended and Restated Supply and License Agreement (“Third Amended SLA”) between the Company and Mayne Pharma, dated December 17, 2018. Previously, the Company conducted a Phase 2b trial studying the use of SUBA-Itraconazole targeting basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (“SUBA-Itraconazole BCCNS”). Mayne Pharma assumed control of the clinical and regulatory program for SUBA-Itraconazole BCCNS in December 2018 pursuant to the Third Amended SLA in exchange for (among other consideration)
to treat fungal infections, and which has an extensive history of safe and effective use in humans. The Company has developed optioned and licensed intellectual property anditraconazole and certain itraconazole analogues.itraconazole.
5 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIXTHREE MONTHS ENDED JUNE 30,MARCH 31, 2023 AND 2022 AND 2021
(Unaudited)
2. Summary of $24,945as of June 30, 2022. Based on the Company’s current operational plan and budget and additional funds provided by Mayne Pharma in July 2022, the Company expects that it has sufficient cash to manage its business into October of 2022, although this estimation assumes the Company does not begin any clinical trials, acquire other drug development opportunities or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements. Available resources may be consumed more rapidly than anticipated, resulting in the need for additional funding. As such time as the Company is able to recommence its research and development activities, significant additional funding will be required to advance the Company’s business. The Company will consider financing these and other corporate efforts and its working capital needs primarily through:
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. Since allAll deferred revenue is related to the SUBA-Itraconazole BCCNSa 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 by Mayne Pharma should be classified asJune 30, 2022March 31, 2023 and December 31, 2021,2022, deferred revenue consisted of $3.0$3.0 million of royalties advanced by Mayne Pharma under the Third Amended SLA.
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 debt instruments purchasedinvestments 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 which is $250,000 for substantially allamounts. The Company continues to monitor the third-party depository accounts. As of June 30, 2022,institutions that hold the Company had no excess of the amount covered by Federal Deposit Insurance Corporation.
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 and purchased
Stock-Based Compensation
The Company accounts for stock-based awards to employees andsixthree months ended June 30,March 31, 2023 and 2022.
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. These differences occur primarily
Management has evaluated the guidance relating to accounting for uncertainty in share-based compensation.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 March 31, 2023.
6 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited)
2. Summary of Significant Accounting Policies (continued):
Recent accounting pronouncements:
Management has considered all recent accounting pronouncements issued, but not effective, and does not believe that theyany will have a material impact on the Company’s financial statements.
3. Mayne Term Debt Facility
The balance outstanding on the Company received loan proceeds of $41,600 (the “PPP Loan”) from Citibank, N.A. pursuant to the Small Business Administration (“SBA”) Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).
Mayne Term Debt Facility |
4. Stockholders’ Equity:
Employee Stock Plans
There was 0 stock-based compensation for the sixthree months ended June 30,March 31, 2023 and March 31, 2022. As of June 30, 2022,March 31, 2023, there were 13,349,461 outstanding common stock options under the EIPCompany’s equity incentive plan of which were vested. There was 0 unamortized stock-based compensation at June 30, 2022.
5. Legal Proceedings:
The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. Except as discussed below, theThe Company is not currently the subject of any pending legal proceedings.
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 and Known Trends and Uncertainties
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. While we are not presently conducting research and development activities with respect to our currently in-licensed technologies and our own intellectual property as a result of pending litigations involving our company (see note 7 to the accompanying financial statements), weWe also have explored and expect to continue to explore acquiring or licensing other innovative preclinicalpre-clinical and clinical stage therapeutics addressing unmet needs and orphan indications beyond cancer.
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 result. Until such pending litigations are resolved, we will continuedrug currently approved by the U.S. Food and Drug Administration (“FDA”) to be unabletreat 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 progress our business. Moreover,the treatment of cancer patients using itraconazole.
Following the resolution of such litigationsthe 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 highly uncertain,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 therefore even if such litigations are resolved, we cannot currently predict ifpatent protected, and how we will be able to recommence full operations.
Critical Accounting Policies
See Note 32 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, 2022March 31, 2023 compared to the three months ended June 30, 2021
Research and Development Expenses.
General and Administrative Expenses.
Interest expense.We recognized $0.05 million in interest expense during the three months ended June 30, 2021. General and administrative expenses for both periods consisted primarily of professional fees, compensation and related costs for corporate administrative staff and Board members.
Interest income. We recognized approximately $0.1 million in general and administrative expenses interest income during the sixthree months ended June 30,March 31, 2023. The interest income was generated from the proceeds resulting from the legal settlement received by the Company in December 2022 and forwhich earned interest within the six months ended June 30, 2021. General and administrative expenses for both periods consisted primarily of professional fees, compensation and related costs for corporate administrative staff and Board members.
8 |
Liquidity and Capital Resources
We had approximately $25,000 in cash on hand at June 30, 2022.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, and additional funds from Mayne Pharma, we expect that we will have sufficient cash to manage our business into October of 2022, although this estimation assumesas now contemplated for more than 12 months. As we do not begin any clinical trials, acquire other drug developmentdetermine capital requirements for existing and new opportunities, or otherwise face unexpected events, costs or contingencies, any of which could affect our cash requirements. Available resources may be consumed more rapidly than anticipated, potentially resultingwe will consider raising additional capital in the need for additional funding.
Item 3. Quantitative and development,Qualitative Disclosures About Market Risk
None.
Item 4. Controls and other corporate efforts and our working capital needs primarily through:
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–15(e)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.
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 first six monthsfiscal quarter of 20222023 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.
9 |
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
Certain information set forth in this Quarterly Report on Formfunds, or (iii) the timing for beginning, completion, and results of, clinical trials and the FDA’s review and/or approval and potential commercial launch of our products and product candidates and regulatory filings related to the same, or (iv) the results of pending litigation involving our company, may differ significantly from those set forth in the forward-looking statements.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 publicallypublicly 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 dismiss the Action.
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.
Item 6. Exhibits.
Number | Description | |
31.1 | ||
Certification of Chief Executive Officer Pursuant | ||
31.2 | Certification of Interim Chief Financial Officer Pursuant | |
32.1 | Certification Pursuant To 18 U.S.C. Section 1350 (*) | |
32.2 | Certification Pursuant To 18 U.S.C. Section 1350 (*) | |
101.ins | XBRL Instance Document | |
101.sch | XBRL Taxonomy Extension Schema Document | |
101.cal | XBRL Taxonomy Calculation Linkbase Document | |
101.def | XBRL Taxonomy Definition Linkbase Document | |
101.lab | XBRL Taxonomy Label Linkbase Document | |
101.pre | XBRL Taxonomy Presentation Linkbase Document | |
104 |
* | 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: | By: | /s/ | |||||
Francis E. O’Donnell Chief Executive Officer (Principal Executive Officer) | |||||||
Date: | By: | /s/ | |||||
James A. McNulty Interim Chief Financial Officer, Treasurer and Secretary (Principal Financial Officer) |
13 |