Inhibitor Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 6, 2024.
View on SEC.govAbout this filing
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, 2024 · Filed Aug 6, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0001493152-24-018805
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0001493152-24-030381
Item 2. 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 16 previous paragraphs and 21 current paragraphs.
11 unchanged; 5 reworded; 1 added; 0 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 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 (1)
Current report
For the six months ended June 30, 2024 compared to the six months ended June 30, 2023
Reworded paragraphs (5)
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 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 basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer. We have 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.
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 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 basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer.
Previous wording
Research and Development Expenses. We incurred $0.2 million of research and development expenses during each of the three months ended March 31, 2024 and March 31, 2023. 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 and remained consistent year-over-year. Research and development expenses will increase in the future, depending on the results from our upcoming FDA meeting.
Current wording
Research and Development Expenses. We incurred $0.2 million of research and development expenses during each of the three months ended June 30, 2024 and June 30, 2023. 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 and remained consistent quarter-over-quarter. We expect research and development expenses to increase in the future, depending on the results from our upcoming FDA meeting.
Previous wording
*General and Administrative Expenses.*We incurred approximately $0.5 million and $0.4 million in general and administrative expenses during the three months ended March 31, 2024 and March 31, 2023, respectively. General and administrative expenses are composed primarily of compensation costs of $0.3 million, insurance costs of $0.1 million and professional services fees of $0.1 million. The increase of approximately $0.1 million is primarily due to variables in other normal operating expenses.
Current wording
*General and Administrative Expenses.*We incurred approximately $0.3 million and $0.5 million in general and administrative expenses during the three months ended June 30, 2024 and June 30, 2023, respectively. During the three months ended June 30, 2024, general and administrative expenses were composed primarily of compensation costs of $0.2 million and insurance costs of $0.1 million. The decrease in general and administrative expenses of approximately $0.2 million is primarily due to reductions in the fees incurred for professional services.
Previous wording
Interest income. We recognized approximately $0.1 million interest income during each of the three months ended March 31, 2024 and March 31, 2023. The interest income is generated from deposits held in our depository accounts.
Current wording
Interest income. We earned approximately $0.1 million of interest income during each of the three months ended June 30, 2024 and June 30, 2023. The interest income is generated from deposits held in our depository accounts.
Previous wording
We are presently focused on our business plan of 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 during 2024 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 $7.7 million as of March 31, 2024, is sufficient to continue to execute our business plan as currently anticipated, for the next 12 months 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 clinical trials and acquire other drug development opportunities, as needed once we determine our requirements for the BCCNS product. As we determine capital requirements for additional opportunities, we will consider raising additional capital in the public market.
Current wording
We are presently focused on our business plan of 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 during 2024 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 $7.1 million as of June 30, 2024, is sufficient to continue to execute our business plan as currently anticipated, assuming we get favorable guidance from the FDA such that we do not require additional clinical trials. Based on our current operational plan and budget, we expect that we will have sufficient cash to manage our business and continue to pursue other drug development opportunities, as needed. As capital requirements for additional opportunities are determined, or additional clinical trials, we will consider raising additional capital in the public market.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
During the six months ended June 30, 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. We were granted a meeting with the Dermatology Division of the FDA, which we subsequently cancelled (with acknowledgment from the FDA), as we believe the pre-IND meeting is more ideally suited for the Oncology Division of the FDA. As such, we are currently pursuing an in-person meeting with the Oncology Division of the FDA.
Current report — wording carried from elsewhere
Research and Development Expenses. We incurred $0.5 million and $0.4 million of research and development expenses during the six months ended June 30, 2024 and June 30, 2023, 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 and remained consistent with the prior year-to-date period. The increase in research and development expenses is the result of the necessary costs to support the incremental R&D activity during the current year. We expect research and development expenses will continue to increase in the future, depending on the results from our upcoming FDA meeting.
Current report — wording carried from elsewhere
*General and Administrative Expenses.*We incurred approximately $0.9 million in general and administrative expenses during each of the six months ended June 30, 2024 and June 30, 2023. During the six months ended June 30, 2024, general and administrative expenses are composed primarily of compensation costs of $0.5 million, insurance costs of $0.2 million and professional services fees of $0.2 million. The slight decrease in general and administrative expenses is primarily due to variables in other operating expenses categories.
Current report — wording carried from elsewhere
Interest income. We earned approximately $0.2 million of interest income during each of the six months ended June 30, 2024 and June 30, 2023. The interest income is generated from deposits held in our depository accounts.