INTI 10-Q
Inhibitor Therapeutics, Inc. (INTI)
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
| 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
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number (including area code):
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.
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).
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 | ☐ | |
| ☒ | 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 13, 2025, there were shares of company common stock issued and outstanding.
Inhibitor Therapeutics, Inc.
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
INHIBITOR THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
AS OF JUNE 30, 2025 AND DECEMBER 31, 2024
(Unaudited) June 30, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other liabilities | ||||||||
| Current operating lease obligations | ||||||||
| Total current liabilities | ||||||||
| Deferred revenue | ||||||||
| Operating lease obligations, less current portion | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity: | ||||||||
| Series A preferred stock, $ par value; shares authorized; shares issued and outstanding at June 30, 2025 and December 31, 2024 | ||||||||
| Series B convertible, redeemable, preferred stock, $ par value; shares authorized; shares issued and outstanding at June 30, 2025 and December 31, 2024 | ||||||||
| Undesignated preferred stock, $par value; shares authorized; shares issued and outstanding at June 30, 2025 and December 31, 2024 | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See notes to condensed financial statements
| 1 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2025 AND 2024
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | $ | $ | $ | $ | ||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Basic and diluted net loss per share | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common stock shares outstanding – basic and diluted | ||||||||||||||||
See notes to condensed financial statements
| 2 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2025 AND 2024
(Unaudited)
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, January 1, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock under equity incentive plan | ||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, June 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, January 1, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock under equity incentive plan | ||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, March 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, June 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See notes to condensed financial statements
| 3 |
INHIBITOR THERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
(Unaudited)
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Non-cash lease expense | ||||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses | ( | ) | ||||||
| Accounts payable and other current liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||
| Operating right-of-use assets obtained in exchange for lease obligations | $ | $ | ||||||
See notes to condensed financial statements
| 4 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
1. Corporate Overview
Overview
The accompanying condensed financial statements of the Company have been prepared 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, 2025, 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, 2024, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 Annual Report”). The accompanying condensed balance sheet as of December 31, 2024 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, $ par value per share.
The results of operations for the three-month and six-month periods ended June 30, 2025, 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 2024 Annual Report and the Company’s other filings with the SEC.
Nature of the Business
The Company is a pharmaceutical development company 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 also 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 primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”), 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.
On
December 12, 2023, the Company entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University
(“JHU”) pursuant to which, JHU granted to the Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930
entitled “New Angiogenesis Inhibitors” (the “Patent”). The Patent relates to the treatment of prostate
cancer, BCC including basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer. Pursuant to the Agreement, the Company
paid JHU an upfront license fee of $
| ● | Royalties within the mid-single digit percentages based on net sales generated from a licensed product, with net sales generated from a licensed product that has exclusivity in the United States due solely to the patent rights provided pursuant the Agreement subject to a higher percentage; |
| 5 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
| ● | Minimum
Annual Royalty (“MAR”) payments of $ | |
| ● | A low-double digit percentage of any consideration received from a sublicensee; and | |
| ● | Certain
development-related milestone payments in the aggregate of $ |
In May 2024, the Company formally requested a Type-B, pre-investigational new drug application (“pre-IND”) meeting with the FDA to obtain feedback on the overall drug development and regulatory plan to use itraconazole for the treatment of BCC tumors in BCCNS patients, for which the Company has engaged the services of external experts in the field to assist with the process. The Company’s Phase IIb clinical study (“HP2001”) uses a novel formulation of itraconazole, which is referenced in the pre-IND submission.
The Company was granted a meeting in June 2024 with the Dermatology Division of the FDA, which was subsequently cancelled (with acknowledgement from the FDA), as the Company believed it required input from the FDA’s Division of Oncology. Additionally, the FDA required further understanding of the right of use to the HP2001 study to further discuss some of the pre-IND questions. The FDA has agreed to consult the Division of Oncology as necessary, and the Company believes to have provided sufficient information around the right of use to proceed with the pre-IND.
The Company has engaged Avior Bio, Inc. (“Avior”), which is currently creating a novel formulation of itraconazole, which formulations are now complete. Upon finalization of the formulation, Avior will conduct a pharmacokinetic (“PK”) crossover study of the generic formulation and the formulation that was used within the HP2001 study in preparation for a new pre-IND and New Drug Application (“NDA”). Given all formulations consist of the same active pharmaceutical ingredients (“API”), it is expected that the Company’s new, novel formulation will have extremely similar properties to the formulation used in the HP2001 clinical study.
In addition, the Company has submitted an application to the FDA to participate in the new Rare Disease Endpoint Advancement (RDEA) pilot program - an initiative jointly led by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
2. Liquidity and Management’s Plans
The
Company is presently focused on its business plan for developing and ultimately commercializing innovative therapeutics based on already
approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery utilizing the new formulation of
itraconazole as the API which has been developed with Avior (see Note 4), coupled with a crossover PK study to demonstrate that the Company’s
formulation of itraconazole delivers comparable levels of itraconazole as the itraconazole formulation used in prior clinical trials,
and approved by the FDA. In doing so, the Company intends to obtain justification for the submission of an NDA without requiring additional
clinical trials. Based on cash on hand, totaling approximately $
| 6 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
3. 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 revenue. 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 all deferred revenue is related to the BCCNS product, which
is yet to be approved by FDA, the Company has determined that
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. The Company maintains cash balances in bank accounts 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. The Company has not experienced any losses in these accounts to date.
Research and Development Expenses
Research and development (“R&D”) costs are expensed in the period in which they are incurred and include salaries, benefits and other related costs to support the Company’s R&D operations, amounts paid to third parties who conduct research and development activities on behalf of the Company, as well as the costs of discovery research, preclinical and clinical development, drug formulation and licensing payments. Upfront and advanced licensing payments for future use in R&D activities are recorded as prepaid expenses and are expensed as the related services are performed.
General and Administrative Expenses
General and administrative (“G&A”) expenses are expensed in the period in which they are incurred and include operating expenses not classified as R&D expenses, such as salaries, benefits, insurance, board of directors’ fees, travel costs, as well as fees for professional services related to accounting, tax and legal matters.
| 7 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
Stock-Based Compensation
The Company accounts for stock-based awards to employees and non-employees using a 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. The 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.
Income Taxes
Deferred tax assets and liabilities are recognized for future tax consequences attributed to differences between the 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.
Leases
The
Company recognizes on its balance sheet right-of-use assets and lease liabilities associated with lease agreements based on the present
value of the future lease payments over the contractual lease term using its incremental borrowing rate on the lease commencement date.
The Company has elected not to recognize a lease liability or right-of-use asset on the balance sheet for leases with an initial term
of
Reclassifications
Certain prior year amounts have been reclassified to conform to current year presentation. The reclassifications relate to certain expenses incurred by the Company that were reclassified from G&A expenses to R&D expenses to better align with the nature of the expenditures. The reclassifications had no impact on the Company’s previously reported financial position, results of operations or cash flows.
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 results of operations or financial position.
| 8 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
4. Related Party Transactions
The
Company has engaged Avior for the development of a novel formulation of itraconazole. Avior is a privately held drug development company
whose President and Chairman of the Board, Niraj Vasisht, is a member of the Company’s Board of Directors. During the six months
ended June 30, 2025 and 2024, the Company incurred $
5. Stockholders’ Equity
Employee Stock Plans
The following table presents a summary of the activity relating to the Company’s issuance of restricted shares of common stock and common stock options:
Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Board of Director restricted share issuances (1) | ||||||||
| Aggregate grant date fair value | $ | million | $ | million | ||||
| Employee stock plan issuances (2) | ||||||||
| Option issuances | ||||||||
| Exercise price per share | $ | $ | ||||||
| Weighted-average grant date fair value per share | $ | $ | ||||||
| Aggregate fair value of options issued (3) | $ | million | $ | million | ||||
| Weighted-average assumptions used to estimate the fair value of the options issued during the period: | ||||||||
| Risk-free interest rate | % | % | ||||||
| Expected term | years | years | ||||||
| Expected volatility | % | % | ||||||
| Dividend yield | ||||||||
| (1) | |
| (2) | |
| (3) |
As of June 30, 2025, there were outstanding common stock options under the Company’s equity incentive plan of which % were vested. There was no unamortized stock-based compensation as of June 30, 2025. The weighted-average remaining contractual life, weighted-average exercise price per share and the aggregate intrinsic value of the outstanding common stock options as of June 30, 2025 were years, $ and approximately $ million, respectively.
6. Commitments and Contingencies
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.
| 9 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
7. Leases
During the six months ended June 30, 2025, the Company executed a lease agreement for office space utilized by finance and operations staff. The lease commenced on March 1, 2025 for a term of three years with no renewal options available. Previously, the Company leased office space under a short-term lease agreement which expired on March 31, 2025.
The components of lease costs were as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating lease cost | $ | $ | $ | $ | ||||||||||||
| Short-term lease cost | ||||||||||||||||
Supplemental information relating to leases was as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Cash paid for amounts included in measurement of lease obligations: | ||||||||||||||||
| Operating cash flows related to operating lease | $ | $ | $ | $ | ||||||||||||
Weighted average remaining lease terms and discount rates were as follows:
| As of June 30, | ||||||||
| 2025 | 2024 | |||||||
| Operating lease: | ||||||||
| Remaining lease term | — | |||||||
| Discount rate | % | |||||||
Future minimum lease payments under non-cancelable operating lease agreement as of June 30, 2025 were as follows:
| Remainder of 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| Total undiscounted minimum lease payments | ||||
| Less: imputed interest | ( | ) | ||
| Present value of lease obligations | $ |
The Company has entered into an agreement with a third party to share the utilization of the leased office space and the related costs associated with the use of the space, which require the third party to reimburse the Company for 50% of all rent payments due under the lease. Despite this arrangement, the Company has not been relieved of its primary obligations under the lease agreement and as a result, the contractual lease payments in the table above as well as the right-of-use asset and lease obligation balances recognized on the accompanying condensed balance sheet do not reflect any reductions for future reimbursement of lease costs from the third party.
| 10 |
INHIBITOR THERAPEUTICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED JUNE 30, 2025, AND 2024
(Unaudited)
8. Segment Information
The Company operates in one reportable segment related to the development and commercialization of therapeutics. The chief operating decision maker for the Company is the Chief Executive Officer (the “CEO”). The Company’s CEO reviews operating results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance and allocating resources. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The CEO uses aggregate net loss to allocate resources in the annual budgeting and forecasting process and also uses that measure as a basis for evaluating financial performance regularly by comparing actual results with established budgets and forecasts.
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies within Note 3. The CEO assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that is also reported on the income statement as net loss. The measure of segment assets is reported on the balance sheets as total assets.
The table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | $ | $ | $ | $ | ||||||||||||
| Less: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Plus: | ||||||||||||||||
| Interest income | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 11 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion and analysis contains certain forward-looking statements that involve risks, uncertainties and assumptions. Actual results and the timing of certain events may differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those which are not within our control.
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 Our 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 nevus syndrome (“BCCNS”), 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. We have developed intellectual property and know-how related to the treatment of cancer patients using itraconazole.
On December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”) pursuant to which, JHU granted to our Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “Patent”). The Patent relates to the treatment of prostate cancer, basal cell carcinoma (“BCC”) including BCCNS, and lung cancer. Pursuant to the Agreement, we paid JHU an upfront license fee of $40,000. In addition to compliance with customary terms and conditions included in the Agreement, we are contractually obligated to pay JHU certain additional consideration, including the following:
| ● | Royalties within the mid-single digit percentages based on net sales generated from a licensed product, with net sales generated from a licensed product that has exclusivity in the United States due solely to the patent rights provided pursuant the Agreement subject to a higher percentage; | |
| ● | Minimum Annual Royalty (“MAR”) payments of $10,000 during each of the first two years of the Agreement, $15,000 during the third year of the Agreement and $50,000 during the fourth year of the Agreement and every year thereafter until the first commercial sale of an associated licensed product. Following the first commercial sale of an associated licensed product, every year thereafter throughout the remaining term of the Agreement the MAR payment is $150,000; | |
| ● | A low-double digit percentage of any consideration received from a sublicensee; and | |
| ● | Certain development-related milestone payments in the aggregate of $3.0 million upon the achieving each of a series of agreed upon milestones, including a successful Phase 3 clinical trial, as well as commercialization and FDA approval of a licensed product, as defined within the Agreement. |
| 12 |
In May 2024, we formally requested a Type-B, pre-investigational new drug application (“pre-IND”) meeting with the FDA to obtain feedback on the overall drug development and regulatory plan to use itraconazole for the treatment of BCC tumors in BCCNS patients, for which we have engaged the services of external experts in the field to assist with the process. Our Phase IIb clinical study (“HP2001”) uses a novel formulation of itraconazole, which we reference in our pre-IND submission.
We were granted a meeting in June 2024 with the Dermatology Division of the FDA, which we subsequently cancelled (with acknowledgement from the FDA), as we believed it required input from the FDA’s Division of Oncology. Additionally, the FDA required further understanding of the right of use to the HP2001 study to further discuss some of the pre-IND questions. The FDA has agreed to consult the Division of Oncology as necessary, and we believe we have provided sufficient information around the right of use to proceed with our pre-IND.
We have engaged Avior Bio, Inc. (“Avior”), which is currently creating a novel formulation of itraconazole, which formulations are now complete. Upon finalization of the formulation, Avior will conduct a pharmacokinetic (“PK”) crossover study of the generic formulation and the formulation that was used within the HP2001 study in preparation for a new pre-IND and New Drug Application (“NDA”). Given all formulations consist of the same active pharmaceutical ingredients (“API”), it is expected that our new, novel formulation will have extremely similar properties to the formulation used in the HP2001 clinical study.
In addition, we have submitted an application to the FDA to participate in the new Rare Disease Endpoint Advancement (RDEA) pilot program - an initiative jointly led by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Critical Accounting Policies
Our critical accounting policies require management to make estimates and assumptions that affect the reported amounts in the financial statements and the accompanying notes. These estimates are based on historical experience, the advice of external experts or on other assumptions management believes to be reasonable. Where actual amounts differ from estimates, revisions are included in the results for the period in which actual amounts become known. Historically, differences between estimates and actual amounts have not had a significant impact on our financial statements. Critical accounting policies and estimates used to prepare the financial statements are discussed with the Audit Committee of our Board of Directors as they are implemented and on an annual basis.
We have no material changes to our Critical Accounting Policies and Estimates disclosure as filed in our 2024 Annual Report.
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Results of Operations
For the three months ended June 30, 2025 compared to the three months ended June 30, 2024
Research and Development Expenses. We incurred $0.3 million and $0.2 million of research and development expenses during the three months ended June 30, 2025 and June 30, 2024, respectively. The expenses are primarily internal personnel costs, consisting of salaries, benefits and other related costs, as well as amounts paid to third parties to support our research and development activities. The increase was primarily the result of third party research and development costs due to the timing of our engagement of Avior and the costs associated with the work performed pursuant to our contractual arrangement. We expect research and development expenses to continue to increase in the future, depending on the results from our upcoming FDA meetings.
General and Administrative Expenses. We incurred approximately $0.4 million and $0.3 million in general and administrative expenses during the three months ended June 30, 2025 and June 30, 2024, respectively. During each of the three months ended June 30, 2025 and 2024, general and administrative expenses were composed primarily of compensation costs of $0.2 million, professional services fees of $0.1 million and insurance costs of $0.1 million. The increase in general and administrative expenses is primarily due to a slight increase in the fees incurred for professional services.
Interest income. We earned approximately $0.04 million and $0.1 million of interest income during the three months ended June 30, 2025 and June 30, 2024, respectively. The interest income is generated from deposits held in our depository accounts and the decrease is the result of less deposits within our money market account during the current period.
For the six months ended June 30, 2025, compared to the six months ended June 30, 2024
Research and Development Expenses. We incurred $0.6 million and $0.5 million of research and development expenses during the six months ended June 30, 2025, and June 30, 2024, respectively. The expenses are primarily internal personnel costs, consisting of salaries, benefits and other related costs, as well as amounts paid to third parties to support our research and development activities. The increase was primarily the result of third party research and development costs due to the timing of our engagement of Avior and the costs associated with the work performed pursuant to our contractual arrangement. We expect research and development expenses to continue to increase in the future, depending on the results from our upcoming FDA meeting.
General and Administrative Expenses. We incurred approximately $0.8 million and $0.9 million in general and administrative expenses during the six months ended June 30, 2025 and June 30, 2024, respectively. During the six months ended June 30, 2025, and June 30, 2024, general and administrative expenses were composed primarily of compensation costs of $0.4 million and $0.5 million, respectively, while professional services fees remained consistent at $0.2 million and insurance costs also remained consistent at $0.2 million. The slight decrease in general and administrative expenses is primarily due to a reduction in compensation costs.
Interest income. We earned approximately $0.1 million and $0.2 million of interest income during the six months ended June 30, 2025 and June 30, 2024, respectively. The interest income is generated from deposits held in our depository accounts and the decrease of $0.1 million compared to the prior period is the result of less deposits within our money market account during the current period.
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Liquidity and Capital Resources
We are presently focused on our business plan for developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. Utilizing the new formulation of itraconazole as the API (Active Pharmaceutical Ingredient) which has been developed with Avior, coupled with a crossover PK study to demonstrate that our formulation of itraconazole delivers comparable levels of itraconazole as the itraconazole formulation used in prior clinical trials, and approved by the FDA, we intend to obtain justification for the submission of an NDA without requiring additional clinical trials. Based on cash on hand, totaling approximately $3.7 million as of June 30, 2025, and our current operational plan and budget, we expect to have sufficient cash to manage our business, continue to pursue the FDA process for the BCCNS product (without further clinical trials), and explore other drug development opportunities for the foreseeable future. Accordingly, upon determination of the requirements for the BCCNS NDA, which we are working to have clarification on within the next six months, we will assess capital requirements necessary to pursue additional opportunities, which may include raising additional capital through sales of equity securities or debt. However, there can be no assurances that we will be successful in the execution of its operational plan nor, if determined to be required, that we will be successful in raising additional capital on economically reasonable terms, if at all.
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.
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 2025 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.
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CAUTIONARY NOTE REGARDING 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, (ii) results from discussions with the FDA, or (iii) the application and availability of corporate funds and our need for future funds. Such forward-looking statements also involve other factors, some of which are outside of our control, 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 fluctuate significantly. 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 our 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 candidates; | |
| ● | 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 2024 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.
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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.
During
the quarter ended June 30, 2025, no directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934) of the
Company
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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 | 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 | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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. |
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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 13, 2025 | By: | /s/ Francis E. O’Donnell |
| Francis E. O’Donnell | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: August 13, 2025 | By: | /s/ James A. McNulty |
| James A. McNulty | ||
| Interim Chief Financial Officer, Treasurer and Secretary | ||
| (Principal Financial Officer) | ||
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