Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program

Apimeds Pharmaceuticals US, Inc. (NYSE:APUS) today welcomed the U.S. Food and Drug Administration's (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company's lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled "Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry", can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.

Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:

"The FDA's draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency's call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulatory encouragement; it's an affirmation of the value of platforms like Apitox.

The guidance opens the door to more efficient development timelines, including the possibility of a single, well-controlled chronic pain trial supported by confirmatory evidence, along with potential fast track or breakthrough designations. For Apitox, this could translate into accelerating our path to regulatory submission, and ultimately, faster relief to patients suffering from osteoarthritis pain.

The FDA's leadership in advancing non-opioid pain therapies is an important step toward reshaping how we approach one of the world's most urgent healthcare challenges. For Apimeds, this guidance reinforces our belief that innovative biologic treatments like Apitox can redefine the standard of care in osteoarthritis and beyond. We are committed to working closely with regulators to bring safer, more effective solutions for pain management to patients as quickly as possible."

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE:APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company's lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds' website does not constitute a part of and is not incorporated by reference into this press release.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "anticipate", "believe", "expect", "plan" and "will" are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and the information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds' actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds' results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds' ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds' filings with the U.S. Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

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Media Contact:

Erik Emerson, CEO

[email protected]