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Inhibitor Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 14, 2026.

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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.

Jun 30, 2026 · Filed Aug 14, 2026

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Notes to Condensed Financial Statements

1. Corporate Overview

Overview

The accompanying condensed financial statements have been prepared without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the condensed financial position, results of operations and cash flows as of June 30, 2026, 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, 2025, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 Annual Report”). The accompanying condensed balance sheet as of December 31, 2025 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 six months ended June 30, 2026, 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 2025 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 U.S. Food and Drug Administration (“FDA”) 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 evaluated and may continue to evaluate, opportunities to acquire or license innovative pre-clinical and clinical stage therapeutics addressing unmet medical needs in cancer and other disease indications, including therapies involving the repurposing of active ingredients from existing approved drugs.

The Company’s primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”) in the United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections with an extensive history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”). Pursuant to the Agreement, JHU granted to the Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “JHU Patent”). The JHU Patent relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer.

During 2026, the Company changed the primary efficacy endpoint it proposes for the registration of itraconazole in BCCNS. The Company now proposes the rate and response of surgically eligible basal cell carcinomas, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted, in place of the per-lesion response rate it had previously proposed. That endpoint was used in the only randomized, placebo-controlled trial ever conducted in Gorlin syndrome. In February 2026, the Company submitted a meeting request and associated briefing materials to the FDA regarding its development program. On May 5, 2026, the FDA provided written responses in lieu of a meeting in which it did not agree that a per-lesion response rate was an appropriate primary efficacy endpoint and recommended that the Company conduct a prospective, randomized, placebo-controlled trial. Following receipt of those responses, the Company repositioned its development strategy around the surgically eligible endpoint, supported by analyses of its completed HP2001 study read against that endpoint. On July 10, 2026, the Company submitted a meeting request and associated briefing package to the FDA to discuss the clinical development of itraconazole for the treatment of surgically eligible basal cell carcinomas in patients with BCCNS. On July 23, 2026, the FDA granted the meeting request, classified the meeting as a Type C meeting, and determined that written responses would be the most appropriate means of responding to the Company’s questions, with the result that a meeting will not be scheduled. The FDA acknowledged receipt of the Company’s briefing package and stated that its goal date for providing written responses is by the end of September 2026. The FDA also noted that if it determines the materials in the briefing package are inadequate, it may cancel or reschedule the agreement to provide written responses, in which case a new meeting request would be required.

HP2001 was an open-label, single-arm study, and the analyses described above are descriptive characterizations of prospectively collected measurements rather than the results of a controlled, hypothesis-testing comparison.

The Company has engaged Avior Bio, Inc. (“Avior”) to develop a novel oral itraconazole capsule formulation intended to serve as its commercial product candidate. Following a formulation development and preclinical screening program, Avior manufactured capsules in 65 mg and 75 mg strengths and conducted a pilot comparative bioavailability study in healthy subjects, the final report for which is dated July 9, 2026. The study demonstrated generally comparable pharmacokinetic profiles between the test formulations and the reference product, with the 75 mg formulation producing systemic exposure most comparable to TOLSURA. For the 75 mg formulation, the geometric mean ratios relative to TOLSURA for itraconazole AUC0-t and Cmax were 105.36% and 102.19%, respectively. The observed variability is consistent with the well-recognized pharmacokinetic characteristics of itraconazole, which has low aqueous solubility and historically variable oral absorption. Based on these results, we intend to advance a ~75 mg formulation in our development program.

On August 14, 2026 we submitted a provisional U.S. patent application covering the novel oral itraconazole formulation developed for the Company by Avior, including its amorphous nano/microparticle composition and related pharmaceutical uses. The filing is intended to establish an initial U.S. priority date, and the Company intends to pursue a broader international patent strategy, including filing under the Patent Cooperation Treaty (“PCT”), with the objective of obtaining patent protection in the United States and other commercially important jurisdictions.

If patent protection is ultimately obtained, the Company expects that it could provide formulation-specific and related use protection extending materially beyond the February 4, 2029 expiration of the licensed JHU Patent. In connection with any future New Drug Application (“NDA”), the Company intends to seek listing in the FDA’s Orange Book of any issued U.S. patents that are eligible for listing. Itraconazole has also received Orphan Drug Designation from the FDA for the treatment of BCCNS, which, if the product is ultimately approved for the designated indication and applicable requirements are satisfied, may provide a separate period of U.S. regulatory exclusivity. There can be no assurance that any patent will issue in the United States or any foreign jurisdiction, that any issued patent will be eligible for Orange Book listing, or that orphan drug exclusivity will ultimately be obtained.

The Company has pursued trademark protection for the GORITRAZOLE™ name in the United States and selected international markets. The Company’s U.S. trademark application, filed January 30, 2025, has been allowed by the USPTO but has not yet proceeded to registration because commercial use of the mark in the United States has not commenced; an acceptable Statement of Use, or a further extension request, is currently due by October 14, 2026. International Registration No. 1847002 under the Madrid Protocol has been registered through the World Intellectual Property Organization, and protection has been granted in the United Kingdom, Ireland and Mexico. The international registration and the registrations in the United Kingdom and Ireland are currently renewable in January 2035, while the Mexican registration is subject to a declaration-of-use requirement in 2029.

In July 2026, the Company entered into a consulting agreement with Professor D. Gareth Evans, MD, FRCP, to provide scientific and clinical consulting services in support of our BCCNS development program, including assistance with regulatory submissions and interactions with the FDA and potential genetic sequencing activities. Professor Evans is Emeritus Professor of Medical Genetics and Cancer Epidemiology at The University of Manchester and has extensive clinical and research experience in inherited cancer-predisposition syndromes, with a particular longstanding involvement in Gorlin syndrome. He has served as a medical advisor to the United Kingdom-based Gorlin Syndrome Group since its formative years in the early 1990s, participated in the Group’s first patient meeting in 1994, and remains identified by The University of Manchester as an advisor to the organization. He is also the author of the GeneReviews clinical reference on Nevoid Basal Cell Carcinoma Syndrome and has published extensively on the genetics, prevalence, genotype-phenotype relationships and clinical manifestations of Gorlin syndrome, including a review of more than 200 affected patients.

As part of the Company’s July 2026 FDA meeting request and briefing package, Professor Evans provided an independent expert letter addressing the disease biology and clinical burden underlying our proposed regulatory approach. In his letter, Professor Evans stated that the available evidence supports BCCs arising in patients with BCCNS as independent clonal events, with fewer than 1% becoming metastatic, and described the substantial morbidity associated with repeated treatment and surgery over a patient’s lifetime. He also reviewed the HP2001 results and expressed his view that itraconazole demonstrated meaningful activity with substantially lower treatment burden than existing systemic alternatives and has the potential to reduce the need for repeated surgical intervention and improve quality of life for patients with BCCNS. His assessment was included in the FDA briefing package in support of the Company’s position that the biology of BCCNS supports evaluation of treatment effect at the level of the individual surgically eligible tumor rather than through an aggregate patient-level RECIST framework.

Under the consulting agreement, Professor Evans will remain available to provide additional scientific and clinical input regarding the BCCNS program, including regulatory matters and potential genetic sequencing work, as requested by the Company.

2. Going Concern

These condensed financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The Company has incurred losses and negative cash flows from operations and expects to incur additional losses until such time that it can generate significant revenue from the licensing of a product once approved by the FDA, which will allow for commercialization of the product candidate. During the six months ended June 30, 2026, the Company incurred a net loss of $1.3 million and had negative cash flows from operations of $1.9 million. Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued before giving consideration to management’s plans to address such conditions. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.

In response to these conditions, management is currently evaluating the scope of the Company’s 2026 operations, including potential financing strategies that include, but are not limited to, the public or private sale of equity or debt securities or from loans or through other strategic collaboration and/or from licensing agreements. On February 19, 2026, the Company entered into a securities purchase agreement with an institutional investor, pursuant to which the Company agreed to sell and issue shares of common stock and warrants in a registered direct offering in exchange for proceeds of $3.0 million. The securities are subject to certain contractual restrictions on transfer, including a nine-month lock-up period. The proceeds have not yet been received and on March 30, 2026 the Company initiated litigation as a result of the institutional investor’s failure to perform its obligations under the securities purchase agreement, including funding the $3.0 million investment in the Company. In the event the proceeds are received, the Company intends to use the proceeds from the offering for working capital and other general corporate purposes. On August 3, 2026 the Court of Chancery of the State of Delaware awarded the Company a default judgment against the institutional investor and the Company is in the process of pursuing payment accordingly.

The Company believes that the impact on its liquidity and cash flow resulting from the offering, if the proceeds are received, will mitigate some of the risk related to the substantial doubt about the Company’s ability to continue as a going concern. However, there can be no assurances that the proceeds will be received pursuant to the securities purchase agreement. Because management’s plans have not yet been fully executed and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not currently alleviate substantial doubt about the Company’s ability to continue as a going concern.

The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

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. Other 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 the FDA, the Company has classified all of the advances of the royalty received from Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”) under the Third Amended Supply and License Agreement (“SLA”) which totaled $3.0 million as non-current.

Cash and Cash Equivalents

The Company considers all highly liquid debt instruments purchased with an original maturity of six 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.

Net Loss per Share

Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by giving effect to all potentially dilutive securities, to the extent dilutive. Because the Company has reported a net loss for the periods presented, basic and diluted net loss per share are the same, as the inclusion of potentially dilutive securities would be antidilutive.

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.

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 Bio, Inc. (“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 each of the six months ended June 30, 2026 and 2025, the Company incurred $0.1 million of costs associated with its engagement of Avior.

5. Stockholders’ Equity

On February 19, 2026, the Company entered into a securities purchase agreement (the “SPA”) with an institutional investor to sell 12 million shares of its common stock and to issue a common stock purchase warrant to purchase up to 7 million additional shares of common stock (the “Warrant”) in exchange for proceeds of $3.0 million. The Warrant has an exercise price of $0.35 per share and a term ofthree years. The proceeds have not yet been received from the institutional investor in accordance with the securities purchase agreement. On March 30, 2026, the Company initiated litigation against the investor, as a result of the investor’s failure to complete the financing and fulfill its obligations under the SPA including, without limitation, funding the $3.0 million investment in the Company provided therein. On August 3, 2026, the Court of Chancery of the State of Delaware awarded the Company a default judgment against the investor for $3.0 million plus attorney’s fees and interest, and the Company is pursuing execution of the judgment.

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,
2026 · 2025
Board of Director restricted share issuances (1)300,000250,000
Aggregate grant date fair value$0.03 million$0.02 million
Employee stock plan issuances (2)
Option issuances—215,000
Exercise price per sharen/a$0.06
Weighted-average grant date fair value per sharen/a$0.04
Aggregate fair value of options issued (3)$—$0.01 million
Weighted-average assumptions used to estimate the fair value of the options issued during the period:
Risk-free interest raten/a3.91%
Expected termn/a5 years
Expected volatilityn/a77.90%
Dividend yieldn/aZero
(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.

During the six months ended June 30, 2026, options to purchase shares of common stock were exercised on a net-settlement basis, resulting in the issuance of 918,423 shares at a weighted-average exercise price of $0.04 per share. The aggregate intrinsic value of options exercised during the period was approximately $0.08 million at the time of exercise. No options were exercised during the six months ended June 30, 2025. No options were forfeited during either the six months ended June 30, 2026 or 2025.

As of June 30, 2026, there were 1,290,000 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 June 30, 2026. 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, 2026 were 4.3 years, $0.15 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 legal proceedings other than the litigation initiated by the Company discussed in Note 5.

7. Segment Information

The Company operates inone 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 are 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,
2026202520262025
Revenues:$—$—$—$—
Less:
Research and development223,564325,623564,126561,681
General and administrative395,033370,150750,103808,643
Loss from operations(618,597)(695,773)(1,314,229)(1,370,324)
Plus:
Interest income4,66435,83113,87177,536
Net loss$(613,933)$(659,942)$(1,300,358)$(1,292,788)

8. Subsequent Events

On July 10, 2026, the Company submitted a meeting request and associated briefing package to the FDA relating to the clinical development of itraconazole for the treatment of surgically eligible basal cell carcinomas in patients with BCCNS, which reflects the change in the Company’s proposed primary efficacy endpoint described in Note 1. On July 23, 2026, the FDA granted the meeting request, classified the meeting as a Type C meeting, and determined that written responses would be the most appropriate means of responding to the Company’s questions, with the result that a meeting will not be scheduled. The FDA stated that its goal date for providing written responses is by the end of September 2026.

On August 3, 2026, the Court of Chancery of the State of Delaware entered a default judgment in favor of the Company against the institutional investor that was party to the Securities Purchase Agreement dated February 19, 2026, relating to the investor’s failure to fund the agreed $3.0 million registered direct offering. The judgment awarded the Company $3.0 million, together with attorney’s fees and applicable interest. The Company is pursuing enforcement and collection of the judgment. The Company has not recorded a receivable or other asset related to the judgment as of June 30, 2026 or as of the date of this filing. Consistent with the accounting for gain contingencies, any amounts recovered will be recognized in the period in which they are received or collection becomes assured. The timing and ultimate amount of any recovery are uncertain and depend on the Company’s ability to enforce the judgment.

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