Inhibitor Therapeutics, Inc.

Previous 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.

Current wording

In June 2024, we were granted a meeting with the Division of Dermatology of the FDA. The meeting was subsequently cancelled, with acknowledgement from the FDA, as we determined that input from the FDA’s Division of Oncology would be required. The FDA requested additional information regarding our 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 we believe we have provided sufficient information regarding our right of use to the HP2001 study data to proceed with our pre-IND process.

Previous 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.

Current wording

We have 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”), we expect that our new, novel formulation to exhibit pharmacological properties extremely similar to those of the formulation used in the HP2001 clinical study.

Previous 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.

Current wording

Research and Development Expenses. We incurred $0.4 million of research and development expenses during each of the three months ended September 30, 2025 and September 30, 2024. 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. We expect research and development expenses to continue to increase in the future, depending on the results from our upcoming FDA meetings.

Previous wording

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.

Current wording

General and Administrative Expenses. We incurred approximately $0.4 million in general and administrative expenses during each of the three months ended September 30, 2025 and September 30, 2024. During each of the three months ended September 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.

Previous 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.

Current wording

Interest income. We earned approximately $0.03 million and $0.1 million of interest income during the three months ended September 30, 2025 and September 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

For the six months ended June 30, 2025, compared to the six months ended June 30, 2024

Current wording

For the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024

Previous wording

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.

Current wording

Research and Development Expenses. We incurred $0.9 million of research and development expenses during each of the nine months ended September 30, 2025 and September 30, 2024. 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. We expect research and development expenses to continue to increase in the future, depending on the results from our upcoming FDA meeting.

Previous 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.

Current wording

*General and Administrative Expenses.*We incurred approximately $1.2 million and $1.3 million in general and administrative expenses during the nine months ended September 30, 2025 and September 30, 2024, respectively. During the nine months ended September 30, 2025, and September 30, 2024, general and administrative expenses were composed primarily of compensation costs of $0.6 million and $0.7 million, respectively, while professional services fees remained consistent at $0.3 million and insurance costs also remained consistent at $0.3 million. The slight decrease in general and administrative expenses is primarily due to a reduction in compensation costs.

Previous wording

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.

Current wording

Interest income. We earned approximately $0.08 million and $0.3 million of interest income during the nine months ended September 30, 2025 and September 30, 2024, respectively. The interest income is generated from deposits held in our depository accounts and the decrease of $0.2 million compared to the prior period is the result of less deposits within our money market account during the current period.

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. 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.

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 $3.0 million as of September 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.