PALATIN TECHNOLOGIES INC

Current report

Inadequate funding for the FDA, the SEC and other U.S. government agencies leading to government shut downs or other disruptions to these agencies’ staffing and operations could prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our operations.

Current report

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 fluctuated in recent years as a result. In addition, government funding of the SEC, and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Current report

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 and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities. If a prolonged government shutdown continues to occur, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, the current or future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Current report

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 authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Previous report

We have been suspended from the NYSE American and are currently not in compliance with the continued listing standards of the NYSE American. Our failure to resume compliance with the continued listing standards or make continued progress toward compliance consistent with a plan of compliance that we submitted to NYSE Regulation may result in the delisting of our common stock.

Previous report

Previously, we received written notification from the NYSE American that we are not in compliance with Section 1003(a)(i) and (ii) of the NYSE American Company Guide (the “Company Guide”). The Company submitted a plan to regain compliance, which was accepted by the NYSE American on December 13, 2023, and was granted a plan period through April 10, 2025, to regain compliance with the foregoing continued listing standards. On October 4, 2024, the Company received written notification from the NYSE American that the Company is not in compliance with Section 1003(a)(iii) of the Company Guide. The Company was not required to submit an additional plan of compliance in response to the additional deficiency identified by the NYSE American but had to regain compliance with Section 1003(a)(iii) of the Company Guide during the plan period under the accepted plan.

Previous report

On April 10, 2025, the Company received written notification from the NYSE American stating that the NYSE Regulation determined to commence proceedings to delist the Company’s common stock from NYSE American. NYSE Regulation has determined the Company is no longer suitable for listing pursuant to Section 1009(a) of the Company Guide as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the Company Guide by the end of the maximum 18-month compliance plan period, which expired on April 10, 2025. On April 14, 2025, the Company appealed the NYSE Regulation’s decision, and on April 15, 2025, the Company requested a hearing with the office of the General Counsel of the NYSE American.

Previous report

On May 7, 2025, the Company received notice from NYSE Regulation that it had suspended trading of the Company’s common stock on the NYSE American LLC stock exchange (“NYSE American”) and determined to commence proceedings to delist the Company’s common stock from the NYSE American as a result of its determination that the Company is no longer suitable for listing pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the Company’s common stock. Trading of the Company’s common stock on the NYSE American was suspended on May 7, 2025 and began trading on the OTC Pink Market on May 8, 2025.The Company has a right to a review of NYSE Regulation’s determination to delist the Company’s common stock by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange. The Company is currently assessing the viability of such an appeal.

Previous report

Because our common stock has been suspended from the NYSE American and is now listed on the Pink Market of the OTC Markets Group under the trading symbol “PTNT”, we could face significant material adverse consequences, including:

Previous report

Such a delisting may also have a negative effect on the price of our common stock and may impair our investors’ ability to sell or purchase our common stock when investors wish to do so.

Previous report

The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Shares of our common stock were considered to be covered securities because they were listed on the NYSE American. Because our common stock is no longer listed on the NYSE American, our common stock would not be deemed covered securities and we are subject to regulation in each state in which we offer our securities.