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Inhibitor Therapeutics, Inc.

For the period ended Sep 30, 2025. Filed Nov 13, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 13, 2025

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Notes to Condensed Financial Statements

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 September 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, $0.0001 par value per share.

The results of operations for the three-month and nine-month periods ended September 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 $40,000. In addition to compliance with customary terms and conditions included in the Agreement, the Company is contractually obligated to pay JHU certain additional considerations, 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.

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.

In June 2024, the Company was granted a meeting with the Division of Dermatology of the FDA. The meeting was subsequently cancelled, with acknowledgement from the FDA, as the Company determined that input from the FDA’s Division of Oncology would be required. The FDA requested additional information regarding the Company’s right of use to the HP2001 study data in order to address certain pre-IND questions. The FDA has agreed to consult the Division of Oncology as necessary, and the Company believes to have provided sufficient information regarding its right of use to the HP2001 study data to proceed with the pre-IND process.

The Company has engaged Avior Bio, Inc. (“Avior”), to develop a novel formulation of itraconazole. Avior has completed the formulation development process, and upon finalization, 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”). As all formulations consist of the same active pharmaceutical ingredients (“API”), the Company expects its new, novel formulation to exhibit pharmacological properties extremely similar to those of 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 $3.0 million as of September 30, 2025, and the Company’s current operational plan and budget, the Company expects to have sufficient cash to manage its 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, the Company 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 the Company will be successful in the execution of its operational plan nor, if determined to be required, that the Company will be successful in raising additional capital on economically reasonable terms, if at all.

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 100% of the advances of the royalty received from Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”) should be classified as non-current. As of September 30, 2025 and December 31, 2024, deferred revenue consisted of $3 million of royalties advanced by Mayne Pharma under the Third Amended Supply and License Agreement (“SLA”).

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.

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 12 months or less. Operating lease expenses on capitalized leases and short-term leases are recognized on a straight-line basis over the respective lease term, inclusive of rent escalation provisions and rent abatements, as a component of general and administrative expenses in the statements of operations.

Reclassifications

Certain prior period amounts have been reclassified to conform to current period presentation. The reclassifications relate to such 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.

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 nine months ended September 30, 2025 and September 30, 2024, the Company incurred $0.2 million and $0.1 million, respectively, of costs associated with its engagement of Avior.

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:

Nine Months Ended September 30,
2025 · 2024
Board of Director restricted share issuances (1)250,000300,000
Aggregate grant date fair value$0.02 million$0.02 million
Employee stock plan issuances (2)
Option issuances215,000290,000
Exercise price per share$0.06$0.08
Weighted-average grant date fair value per share$0.04$0.07
Aggregate fair value of options issued (3)$0.01 million$0.02 million
Weighted-average assumptions used to estimate the fair value of the options issued during the period:
Risk-free interest rate3.91%4.33%
Expected term5 years5 years
Expected volatility77.90%129.18%
Dividend yieldZeroZero
(1)The shares of common stock were fully vested upon issuance but are restricted from trading for a period of one year from the date of grant.
(2)The options were fully vested upon issuance and have contractual terms of 10 years.
(3)Determined by using the Black-Scholes valuation model.

As of September 30, 2025, there were 3,080,646 outstanding common stock options under the Company’s equity incentive plan of which 100% were vested. There was no unamortized stock-based compensation as of September 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 September 30, 2025 were 4.8 years, $0.09 and approximately $0.01 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.

7. Leases

During the nine months ended September 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 ofthree 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 September 30,Nine Months Ended September 30,
2025202420252024
Operating lease cost$8,077$—$18,845$—
Short-term lease cost—5,231—13,181

Supplemental information relating to leases was as follows:

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Cash paid for amounts included in measurement of lease obligations:
Operating cash flows related to operating lease$7,839$—$18,291$—

Remaining lease term and discount rate were as follows:

As of September 30,
20252024
Operating lease:
Remaining lease term2.4 years—
Discount rate7.5%—

Future minimum lease payments under non-cancelable operating lease agreement as of September 30, 2025 were as follows:

Remainder of 2025$7,839
202632,140
202733,104
20285,544
Total undiscounted minimum lease payments78,627
Less: imputed interest(6,991)
Present value of lease obligations$71,636

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.

8. Segment Information

The Company operates in one reportable segment related to the development and commercialization of therapeutics. The chief operating decision maker (“CODM”) for the Company is the Chief Executive Officer (the “CEO”). The Company’s CODM 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 CODM 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 CODM 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. 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 September 30,Nine Months Ended September 30,
2025202420252024
Revenues:$—$—$—$—
Less:
Research and development377,789369,621939,470869,756
General and administrative363,426443,5751,172,0691,303,404
Loss from operations(741,215)(813,196)(2,111,539)(2,173,160)
Plus:
Interest income29,03182,239106,567255,802
Net loss$(712,184)$(730,957)$(2,004,972)$(1,917,358)

9. Subsequent Events

In October 2025, the Company’s Board of Directors approved the 2025 Equity Incentive Plan (the “2025 Plan”). The 2025 Plan provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards. The maximum aggregate number of shares of the Company’s common stock that may be issued under the 2025 Plan is 20 million shares of common stock. The adoption of the 2025 Plan is subject to shareholder approval and will be terminated if not approved by the shareholders of the Company within 12 months of the effective date of approval by the Company’s Board of Directors.

In October 2025, the Company entered into a performance-based master services agreement (the “Frameshift Agreement”) with Frameshift Management, Inc. (“Frameshift”), pursuant to which Frameshift shall provide the Company with consulting services for biostatistics, regulatory, business development and strategic consulting in support of Company’s programs in BCC in Gorlin’s syndrome, and related services that the Company may request utilizing the Company’s proprietary new formulation of itraconazole. Compensation for such services will be in accordance with agreed upon rates, with additional compensation in the form of warrants exercisable for shares of the Company’s common stock that would vest in the event of one of the following: (1) license or sale of the Company’s itraconazole program, (2) sale of a majority of the Company’s equity (3) a merger or other change of control transaction wherein ownership/management of the Company’s itraconazole program transfers to a third party, or (4) FDA’s approval of the Company’s itraconazole program followed by the Company proceeding to commercialize rather than selling or licensing.

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