Inhibitor Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 26, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 26, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-28.
0001641172-25-001190
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-26.
0001493152-26-012751
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 21 previous paragraphs and 23 current paragraphs.
11 unchanged; 7 reworded; 5 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
In October 2025, we entered into a performance-based master services agreement with Frameshift Management, Inc. (“Frameshift”) to provide regulatory, biostatistical and strategic consulting services supporting our lead development program targeting basal cell carcinomas associated with Gorlin Syndrome. Frameshift performs services under project-specific statements of work supporting our preparation of regulatory submissions, coordination of supporting analyses and overall advancement of our BCCNS development strategy.
Current report
Frameshift supported us in the preparation of a regulatory meeting request and associated briefing materials submitted to the FDA in February 2026 and is expected to assist in the preparation of materials supporting a potential NDA subject to regulatory feedback and the outcome of FDA discussions regarding our proposed development pathway
Current report
We have incurred losses and negative cash flows from operations and expect to incur additional losses until such time that we can generate significant revenue from the licensing of a product once we receive approval by FDA, which will allow for commercialization of the product candidate. During the year ended December 31, 2025, we incurred a net loss of $3.3 million and had negative operating cash flows of $3.2 million. Given our projected operating requirements and our existing cash and cash equivalents, we are projecting insufficient liquidity to sustain our operations through one year following the date that the financial statements are issued, before giving consideration to management’s plans to alleviate such conditions. These conditions and events raise substantial doubt about our ability to continue as a going concern.
Current report
In response to these conditions, management is currently evaluating the scope of our 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, we entered into a securities purchase agreement with an institutional investor, pursuant to which we 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. Once received, we intend to use the proceeds from the offering for working capital and other general corporate purposes.
Current report
We believe that the impact on our liquidity and cash flows resulting from the offering, once the proceeds are received, will mitigate some of the risk related to the substantial doubt about our 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 our plans have not yet been fully executed and are not within our control, the implementation of such plans cannot be considered probable. As a result, we have concluded that our plans do not currently alleviate substantial doubt about our ability to continue as a going concern.
Removed paragraphs (3)
Previous report
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 2b clinical study (HP2001) uses a novel formulation of itraconazole, which we reference in our pre-IND submission.
Previous report
The Company was 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.
Previous report
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. We expect to progress with the FDA to reach a conclusion on whether any additional clinical trials are required before submitting our New Drug Application (NDA). Our current cash on hand, approximately $5.6 million on December 31, 2024, is sufficient to continue to execute our business plan as currently anticipated, without another required clinical trial. Based on our current operational plan and budget, we expect that we will have sufficient cash to manage our business and continue to pursue the FDA process for the BCCNS product (without further clinical trials) and explore other drug development opportunities. Once we determine our requirements for the BCCNS NDA, we will assess capital requirements for additional opportunities, at which time we will consider raising additional capital in the public market.
Reworded paragraphs (7)
Previous wording
Our current primary focus is on the development of therapies initially for BCCNS, prostate and lung cancers in the United States utilizing itraconazole, a drug currently approved by the 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.
Current wording
Our current primary focus is on the development of therapies initially for BCCNS cancers in the United States utilizing itraconazole, a drug currently approved by the 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.
Previous wording
On December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”). Pursuant to the Agreement, 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, BCC including BCCNS, and lung cancer.
Current wording
On December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”). Pursuant to the Agreement, 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, 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:
Previous wording
We have engaged Avior Bio, Inc. (“Avior”), which is currently creating a novel formulation of itraconazole from which results are expected in the next several months. 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. 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 IND and 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.
Current wording
We have engaged Avior Bio, Inc. (“Avior”), to develop a novel formulation of itraconazole. Avior has completed the formulation development process and is conducting 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”), we expect that our new, novel formulation to exhibit pharmacological properties extremely similar to those of the formulation used in the HP2001 clinical study. The PK crossover study is expected to take approximately six weeks to complete with reporting anticipated shortly thereafter.
Previous wording
Research and Development Expenses. We incurred $1.7 million and $1.4 million in research and development expenses during the years ended December 31, 2024 and 2023, respectively. These expenses are primarily internal personnel costs, consisting of salaries, benefits and other related costs, as well as amounts paid to third parties to support the Company’s research and development activities. The $0.3 million increase is primarily the result of an increase in internal personnel costs associated with the Company’s R&D activities as a result of the relative significance of R&D activity and developments during the year ended December 31, 2024 compared to the year ended December 31, 2023.
Current wording
Research and Development Expenses. We incurred $1.7 million and $1.8 million in research and development expenses during the years ended December 31, 2025 and 2024, respectively. These expenses are primarily internal personnel costs, consisting of salaries, benefits and other related costs, as well as amounts paid to third parties to support the Company’s research and development activities. The $0.1 million decrease is primarily the result of a decrease in internal personnel costs associated with the Company’s R&D activities as a result of the relative significance of R&D activity and developments during the year ended December 31, 2025 compared to the year ended December 31, 2024. We anticipate that research and development expenses could increase in the future, depending on the results from our upcoming FDA meetings.
Previous wording
General and Administrative Expenses. We incurred approximately $2.0 million in general and administrative expenses during each of the years ended December 31, 2024, and 2023. During the year ended December 31, 2024, general and administrative expenses were composed primarily of compensation costs of $1.1 million, professional services fees of $0.5 million and insurance costs of $0.4 million, which represented an increase of $0.2 million in compensation costs and a decrease of $0.2 million in insurance costs, year-over-year.
Current wording
General and Administrative Expenses. We incurred approximately $1.7 million and $1.9 million in general and administrative expenses during the years ended December 31, 2025, and 2024, respectively. During the year ended December 31, 2025, general and administrative expenses were composed primarily of compensation costs of $1.0 million, professional services fees of $0.4 million and insurance costs of $0.3 million, which reflects a decrease of $0.1 million in compensation costs and a decrease of $0.1 million in insurance costs, year-over-year.
Previous wording
Interest income. We earned approximately $0.3 million and $0.4 million of interest income during the years ended December 31, 2024 and December 31, 2023, respectively. The interest income is generated from deposits held in our depository accounts and will continue to fluctuate consistent with the level of deposits held in our accounts.
Current wording
Interest income. We earned approximately $0.1 million and $0.3 million of interest income during the years ended December 31, 2025 and December 31, 2024, respectively. The interest income is generated from deposits held in our depository accounts and will continue to fluctuate consistent with the level of deposits held in our accounts.
Previous wording
In accordance with the Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”), we are contractually obligated to make Minimum Annual Royalty (“MAR”) payments to JHU, as defined within the Agreement. As of December 31, 2024, the remaining MAR payments owed are as follows: By January 1, 2025: $10,000; By January 1, 2026: $15,000; By January 1, 2027 and every year thereafter until the first commercial sale of an associated licensed product: $50,000.
Current wording
In accordance with the Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”), we are contractually obligated to make Minimum Annual Royalty (“MAR”) payments to JHU, as defined within the Agreement. As of December 31, 2025, the remaining MAR payments owed are as follows: By January 1, 2026: $15,000; By January 1, 2027 and every year thereafter until the first commercial sale of an associated licensed product: $50,000.