Company Description

We are a clinical stage biopharmaceutical company that is in the process of developing Apitox, an intradermally administered bee venom-based toxin which potentially exhibits diverse therapeutic effects. Apitox is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) in the South Korea as “Apitoxin.” Apimeds US is not associated with the market, sale and revenues generated from Apitoxin in South Korea, and Apitoxin has not been approved by the U.S. Food and Drug Administration (the “FDA”) for any indication. Apimeds is currently developing Apitox as a potential osteoarthritis (“OA”) treatment for patients with knee pain who failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. In 2003, after completing successful Phase I, II, and III trials, the Korean Ministry of Food and Drug Safety (the “MFDA”) approved the use of Apitoxin to treat pain and mobility in patients with OA in South Korea. Apitoxin has been used in the South Korea to treat the reduction of pain associated with OA since 2003. Additionally, a post-marketing/approval safety study in South Korea followed 3,194 patients from 2003 through 2009, with no serious adverse events. In 2013, the FDA authorized Apimeds Korea to conduct a preliminary Phase III to study the same indication approved in South Korea — the use of Apitoxin to treat pain and inflammation in patients with OA — which was completed in 2018 (the “Apimeds Korea Phase III OA Trial”). On August 2, 2021, we entered into an agreement with Apimeds Korea, a principal stockholder of Apimeds US (the “Business Agreement”). Pursuant to the Business Agreement, Apimeds Korea granted to the Company a sublicensable, royalty-bearing license to utilize all prior clinical development data associated with Apitoxin, Apitox, and all related names, and to advance clinical research, develop, manufacture and commercialize and sell Apitox in the United States. Based on the results from the Apimeds Korea Phase III OA Trial, which demonstrated therapeutic effect in the treatment group compared to the placebo group, but in combination with prior development by Apimeds Korea, did not meet the FDA’s standards for approval, as the study population was too small and the methods for handling missing data were inadequate, resulting in a study that did not demonstrate a significant treatment effect. We will be pursuing a second Phase III trial to meet agreed upon FDA standards. Based on results from the Apimeds Korea Phase III OA Trial, we have evaluated the most appropriate population, defined as advanced knee OA patients, which will range from defined grade 2, 3 and 4 within this treatment group, to continue to progress our own Phase III trial in knee OA. Pursuant to our previous correspondence with the FDA, we have designed and will implement our Phase III trial to best address our patient population, appropriate dosing, and the most effective way to evaluate Apitox in meeting the patient population’s needs. Apimeds Korea has also engaged in clinical trials to explore the therapeutic effect of Apitoxin in patients with multiple sclerosis (“MS”), including in 2014, submitting an Investigational New Drug Application (“IND”) 122804 to run a Phase III clinical trial. Pursuant to the Business Agreement, Apimeds Korea transferred sponsorship of IND 122804 to Apimeds US in October 2020. Pursuant to the written correspondence from the FDA, as of the date of this prospectus, there are no clinical holds relating to the planned clinical trials. However, we have made the strategic decision to focus our MS efforts on the early prosecution of appropriate patient populations through non-registered corporate sponsorship studies and will not be pursuing a Phase III trial for MS at this time. Chronic diseases such as OA and MS cause considerable economic, personal, and societal burden. These diseases negatively impact quality of life and progress from the time of onset until death. We are dedicated to developing innovative therapies using Apitox that seek to restore the health and enhance the quality of life of patients suffering with these diseases. To this date, Apimeds has generated no revenue from the sale and or distribution of Apitox in the United States. We have generated our clinical data and an opportunity to advance treatment opportunities with proceeds received from sales of our securities to prior investors and the work of our partners, Apimeds Korea and Inscobee Inc. We do not currently hold any debt as prior investments in the form of convertible notes have since been converted to equity. We believe that naturalized bee venom can provide an additive treatment, that pending clinical demonstration of success and FDA approval, could provide value to OA patients in need and the physicians treating OA patients, and potentially MS. The advancement of Apitox as a candidate and Apimeds as a company, will be dictated by the clinical data and the regulatory agencies interpretation of such data in regard to effectiveness, safety and potential benefit beyond existing treatment options. --- Apimeds US was incorporated in Delaware on May 11, 2020. We are located at 2 East Broad Street, 2nd Floor, Hopewell, New Jersey 08525. Our telephone number is 808-209-7887. Our website address is www.apimedspharmaus.com.