Inhibitor Therapeutics, Inc.

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, basal cell carcinoma (“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 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:

Previous wording

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.

Current wording

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.

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 third quarter of 2025. 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”), 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.

Previous wording

Research and Development Expenses. We incurred $0.2 million and $0.3 million of research and development expenses during the three months ended March 31, 2025, and March 31, 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 slight decrease quarter-over-quarter was the result of a reduction in the internal personnel costs classified as research and development expenses. Despite this slight decrease during the current period, we expect research and development expenses to increase in the future, depending on the results from our upcoming FDA meeting.

Current wording

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.

Previous wording

Interest income. We earned approximately $0.04 million and $0.1 million of interest income during the three months ended March 31, 2025 and March 31, 2024, respectively. The interest income is generated from deposits held in our depository accounts and the decrease of $0.06 million quarter-over-quarter is the result of less deposits within our money market account during the current period.

Current wording

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.

Previous wording

*General and Administrative Expenses.*We incurred approximately $0.4 million and $0.5 million in general and administrative expenses during the three months ended March 31, 2025 and March 31, 2024, respectively. During the three months ended March 31, 2025, and March 31, 2024, general and administrative expenses were composed primarily of compensation costs of $0.2 million and $0.3 million, respectively, while professional services fees remained consistent quarter-over-quarter at $0.1 million and insurance costs remained consistent quarter-over-quarter at $0.1 million, with the overall reduction in general and administrative expenses primarily the result of a reduction in compensation costs.

Current wording

*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.

Previous wording

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 $4.3 million as of March 31, 2025, 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.

Current wording

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.