Apimeds Pharmaceuticals delays quarterly report for period ended June 30, 2025

The late-filing notice

Apimeds Pharmaceuticals US, Inc. told the SEC on August 14, 2025 that it cannot file its Form 10-Q for the quarter ended June 30, 2025 by the due date. The notification of late filing, made on Form 12b-25, says the company is still finalizing the quarter's financial statements and will need more time to complete them.

A Form 12b-25 notice gives a company a short extension when a periodic report cannot be filed without unreasonable effort or expense. For a quarterly report, the extension runs to the fifth calendar day after the due date. Apimeds says it expects to file within that window.

The notice is signed by Erik Emerson as chief executive, who is also the contact person. The company's address is 100 Matawan Rd., Suite 325, in Matawan, New Jersey. The form says the company has filed all other periodic reports required over the past 12 months. It checked "No" when asked whether it expects a significant change in results from the same period last year. The notice gives no revenue, loss or cash figures for the quarter.

What the company is developing

Apimeds is a clinical-stage biopharmaceutical company developing Apitox, an intradermal injection made from bee venom. Its focus is inflammation and pain from knee osteoarthritis (OA) and, to a lesser extent, multiple sclerosis (MS). The company says Apitox could be an alternative to nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen and diclofenac, which it says carry risks of bleeding, heart attack, stroke and heart failure. It presents that as its belief, and the business section offers no head-to-head trial against those drugs.

The company says it has no association with Apitoxin's sales in South Korea, where Apimeds Inc. (Apimeds Korea) markets the product for OA. Apitoxin was approved there in 2003 to treat pain and mobility in OA patients. A post-marketing safety study in South Korea followed 3,194 patients from 2003 through 2009 and reported no serious adverse events. The company says Apitoxin has not been approved by the FDA for any indication.

The company cites figures from MedicalNewsToday: about 500 million people worldwide have OA, around 7% of the global population, and over 32 million people in the United States. It says the knee accounts for 61% of years lived with disability from OA, based on ScienceDirect.

The trial record and what comes next

The first of two required U.S. Phase III trials, with 330 patients, was authorized in 2013 and completed in 2018, with no serious adverse events. The business section says the trial showed a therapeutic effect against placebo, and in the same passage describes "statistical and clinically significant improvements in all outcome measures" of pain, physical function and disease assessment. It also says the trial "did not demonstrate a significant treatment effect". The company attributes that outcome to a population that was too small and inadequate handling of missing data. The filing does not reconcile the two descriptions.

The company says it will run a second Phase III trial to meet agreed FDA standards. It says it has defined the population as advanced knee OA patients, graded 2, 3 and 4, and that its trial design follows earlier FDA correspondence. The business section gives no start date or enrollment target for that trial. It says its MS work depends on the success of that knee OA trial.

The late-filing notice does not give the company's cash, losses or debt. The company expects to file the overdue 10-Q within the extension period.

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