Form 10-Q Inhibitor Therapeutics, For: Jun 30
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
th Street |
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(Address of principal executive offices) |
(Zip Code) |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
Page |
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Part I. Financial Information |
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Item 1. |
Condensed Financial Statements (unaudited) |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 1 |
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Item 1A. |
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Item 2 |
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Item 3 |
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Item 4 |
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Item 5 |
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Item 6. |
1 5 |
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S-1 |
(Unaudited) |
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June 30, 2022 |
December 31, 2021 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Prepaid expenses |
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Total current assets |
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Total assets |
$ | $ | ||||||
LIABILITIES AND STOC K HOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
Dividends payable, related party |
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Notes payable, related party |
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Interest payable, related party |
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Other liabilities |
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Total current liabilities |
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Deferred revenue, related party |
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Total liabilities |
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Commitments and contingencies (note 7) |
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Stockholders’ deficit: |
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Series A Preferred Stock, $ |
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Series B Convertible, Redeemable, Preferred Stock, $ |
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Undesignated Preferred Stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ deficit |
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Total liabilities and stockholders’ deficit |
$ | $ | ||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
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2022 |
2021 |
2022 |
2021 |
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Revenues: |
$ | $ | $ | $ | ||||||||||||
Expenses: |
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Research and development |
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General and administrative |
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Total Expenses: |
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Loss from operations |
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Interest expense, related party |
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Gain on loan forgiveness |
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Net loss |
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Preferred stock dividend |
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Net loss applicable to common stockholders |
$ | ( |
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) | $ | ( |
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Basic and diluted net loss applicable to common stockholders per share |
$ | ( |
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) | $ | ( |
) | $ | ( |
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Weighted average common stock shares outstanding – basic and diluted |
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Preferred Stock – Series B |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
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Shares |
Amount |
Shares |
Amount |
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Balances, January 1, 2022 |
$ | $ | $ | $ | ( |
) | $ | ( |
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Preferred stock dividends, related party |
— | — | — | — | — | ( |
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Net loss |
— | — | — | — | — | ( |
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Balances, March 31, 2022 |
$ | $ | $ | $ | ( |
) | $ | ( |
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Preferred stock dividends, related party |
— | — | — | — | — | ( |
) | ( |
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Net loss |
— | — | — | — | — | ( |
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Balance, June 30, 2022 |
$ | $ | $ | $ | ( |
) | $ | ( |
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Preferred Stock – Series B |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
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Shares |
Amount |
Shares |
Amount |
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Balances, January 1, 2021 |
$ | $ | $ | $ | ( |
) | $ | ( |
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Common shares issued in payment of Preferred Stock dividend, related party |
— | — | — | |||||||||||||||||||||||||
Stock based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Preferred stock dividends, related party |
— | — | — | — | — | ( |
) | ( |
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Net loss |
— | — | — | — | — | ( |
) | ( |
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Balances, March 31, 2021 |
$ | $ | $ | $ | ( |
) | $ | ( |
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Preferred stock dividends, related party |
— | — | — | — | — | ( |
) | ( |
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Net loss |
— | — | — | — | — | ( |
) | ( |
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Balances, June 30, 2021 |
$ | $ | $ | $ | ( |
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Six Months Ended June 30, |
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2022 |
2021 |
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Operating activities: |
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Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock based compensation |
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Gain on loan forgiveness |
( |
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Changes in assets and liabilities: |
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Prepaid expense and other assets |
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Accounts payable and other current liabilities |
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Net cash used in operating activities |
( |
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Financing activities: |
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Proceeds from note payable, related party |
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Net cash provided by financing activities |
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Net change in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | $ | ||||||
Non-cash financing activities: |
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Issuance of common stock for payment of Preferred Stock dividend |
$ | $ | ||||||
Accrued, but unpaid dividends |
$ | $ |
See notes to condensed financial statements |
1. |
Corporate overview: |
2. |
Liquidity and management’s plans: |
• |
proceeds from public and private financings (including most recently, financing from the Company’s majority shareholder, Mayne Pharma) and, potentially, from other strategic transactions; |
• |
royalty revenue from Mayne Pharma from sales of SUBA-Itraconazole BCCNS upon and assuming approval by FDA (after earned royalties have been applied to any royalties advanced under Third Amended SLA, although it is uncertain if and when such FDA approval will be obtained); |
• |
proceeds from the exercise of outstanding warrants previously issued in private financings (including, potentially, warrants held by the Company’s majority shareholder, Mayne Pharma); |
• |
potential partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of products for which the Company would expect to receive upfront milestone and royalty payments; |
• |
potential licensing and joint venture arrangements with third parties, including other pharmaceutical companies where we would receive funding based on out-licensing our product; and |
• |
government or private foundation grants or loans which would be awarded to the Company to further develop the Company’s current and future therapies, or government payroll protection or similar programs available as a result of the novel coronavirus outbreak. |
3. |
Summary of Significant Accounting Policies: |
3. |
Summary of Significant Accounting Policies (continued): |
4. |
Notes Payable: |
5. |
Mayne Term Debt Facility |
5. |
Mayne Term Debt Facility (continued): |
6. |
Stockholders’ Equity: |
7. |
Legal Proceedings: |
7. |
Legal Proceedings (continued): |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
• | proceeds from public and private financings (including most recently financing, from our majority shareholder, Mayne Pharma) and, potentially, from other strategic transactions; |
• | royalty revenue from Mayne Pharma from sales of SUBA-Itraconazole BCCNS upon and assuming approval by FDA (after earned royalties have been applied to any royalties advanced under Third Amended SLA, although it is uncertain if and when such FDA approval will be obtained); |
• | proceeds from the exercise of outstanding warrants previously issued in private financings (including, potentially, warrants held by our majority shareholder, Mayne Pharma); |
• | potential partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of our products for which we would expect to receive upfront milestone and royalty payments; |
• | potential licensing and joint venture arrangements with third parties, including other pharmaceutical companies where we would receive funding based on out-licensing our product; and |
• | government or private foundation grants or loans which would be awarded to us to further develop our current and future therapies, or government payroll protection or similar programs available as a result of the novel coronavirus outbreak. |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
Item 4. |
Controls and Procedures |
• | the timing for resolution of any pending litigation involving our company, and the nature of any such resolution, if achieved; |
• | acceptance of our business model (namely the repurposing of a specialty formulation of the drug itraconazole for the treatment of cancer or other diseases, and the potential acquisition or license of other pharmaceutical technologies) by investors and potential commercial collaborators; |
• | the uncertainties regarding the impact of the novel coronavirus outbreak and related governmental actions on our business model and our ability to implement our business; |
• | our future capital requirements and our ability to satisfy our capital needs; |
• | our ability to commence and complete required clinical trials of our product candidate and obtain approval from the FDA or other regulatory agencies in different jurisdictions; |
• | matters associated with the fact that Mayne Pharma is our majority stockholder and key licensor; |
• | 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 2019 Annual Report and other factors detailed from time to time in our other filings with the SEC. |
Item 1. |
Legal Proceedings |
Item 1A. |
Risk Factors. |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds. |
Item 3. |
Defaults upon Senior Securities. |
Item 4. |
Mine Safety Disclosures. |
Item 5. |
Other Information. |
Item 6. |
Exhibits. |
Number |
Description | |
31.1 | Certification of Chief Executive Officer Pursuant To Sarbanes-Oxley Section 302 | |
31.2 | Certification of 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 | 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 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
* | 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. |
INHIBITOR THERAPEUTICS, INC. | ||||||
Date: August 12, 2022 | By: | /s/ Nicholas J. Virca | ||||
Nicholas J. Virca President and Chief Executive Officer (Principal Executive Officer) | ||||||
Date: August 12, 2022 | By: | /s/ Garrison J. Hasara | ||||
Garrison J. Hasara, CPA Chief Financial Officer and Treasurer (Principal Financial Officer) |
Exhibit 31.1
Certification of Chief Executive Officer
Pursuant to Rule 13a-14(a)
I, Nicholas J. Virca, 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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting.
Date: August 12, 2022
/s/ Nicholas J. Virca |
Nicholas J. Virca |
President and Chief Executive Officer |
Exhibit 31.2
Certification of Chief Financial Officer
Pursuant to Rule 13a-14(a)
I, Garrison J. Hasara, 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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting.
Date: August 12, 2022
/s/ Garrison J. Hasara |
Garrison J. Hasara |
Chief Financial Officer and Treasurer |
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, 2022, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Nicholas J. Virca, President and 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/ Nicholas J. Virca |
Nicholas J. Virca |
President and Chief Executive Officer |
August 12, 2022 |
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 March 31, 2022, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Garrison J. Hasara, Chief Financial Officer, Treasurer, Chief Compliance Officer, 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/ Garrison J. Hasara | ||
Garrison J. Hasara | ||
Chief Financial Officer, Treasurer, Chief Compliance Officer, and Secretary | ||
August 12, 2022 |
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