INTI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• 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 Syndro…

• 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 the FDA, which will allow for commercialization of the product candidate. During …

• 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 f…

• 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 rece…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• 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 …

• 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 ri…

• In addition, we have submitted an application to the FDA to participate in the new Rare Disease Endpoint Advancement (RDEA) pilot program - an initiative jointly led by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

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

• 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 a…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• ● those risk factors listed under Item 1A of our 2025 Annual Report and other factors detailed from time to time in our other filings with the SEC.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• ● the impact of the current U.S. government shutdown, and funding shortages at governmental and regulatory agencies on which we rely; and

• ● those risk factors listed under Item 1A of our 2024 Annual Report and other factors detailed from time to time in our other filings with the SEC.

Text added vs the prior filing · source: 10-Q · 2026-05-15

• Uncertainty relating to the pending securities purchase agreement and related litigation could adversely affect our liquidity and business operations.

• In February 2026, we entered into a securities purchase agreement with an institutional investor providing for aggregate gross proceeds of approximately $3.0 million. As of the date of this Quarterly Report, the transaction has not been consummated, and we have initiated litigation relating to the i…

• There can be no assurance regarding the timing or outcome of the litigation, whether the transaction will ultimately close, or whether we will receive any proceeds under the agreement. The uncertainty associated with the pending transaction and related legal proceedings may adversely affect our liqu…

• If we are unable to obtain sufficient funding on acceptable terms, we may be required to delay, reduce or discontinue certain operational, regulatory or development activities.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Other than as set forth below, there have been no material changes to the risk factors set forth in our 2024 Annual Report.

• Disruptions at the FDA, the SEC and other government agencies could hinder their ability to perform normal business functions on which the operation of our business may rely, which could negatively impact our business.

• The ability of the FDA to review and approve new products can be affected by a variety of factors, including government funding, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctua…

• Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, including in October 2025, the U.S. government shut down several times an…

• If a prolonged government shutdown occurs or continues to occur, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory a…