We are a clinical biopharmaceutical company developing an anti-inflammatory treatment derived from bee venom. (Incorporated in Delaware)

We are developing Apitox, an intradermal treatment derived from bee venom, to treat inflammation and pain associated with osteoarthritis of the knee. 

Apimeds, a subsidiary of Inscobee, markets and sells Apitox in South Korea. 

We are pursuing a second Phase 3 trial of Apitox. Our previous Phase 3 trial, completed in 2018, did not meet the FDA’s standards for approval because the study population was too small and the methods for handling missing data were inadequate.

More from the prospectus:

Apitox is a purified, pharmaceutical grade bee venom of the Apis mellifera, or western honeybee, which is classified by the FDA as an active pharmaceutical ingredient (“API”). Bee venom has been used in Asia and Europe as a therapeutic to treat pain for hundreds of years. Bee venom contains the peptides apamin and adolapin. Although these peptides act as toxins, they possess anti-inflammatory and pain-relieving properties.

While not FDA approved in a controlled, prescription based biologic environment for defined indications, the use of bee venom has been FDA approved as an “under the skin injection” to reduce the allergic reactions to bee stings. Apimeds Korea has developed a proprietary method and process for turning extracted bee venom into a lyophilized powder for reconstitution prior to intradermal dose injections, which it sells in South Korea as Apitoxin. We intend to use a similar process with respect to Apitox, pursuant to the Business Agreement, which gives us a license to utilize all prior clinical development data associated with Apitoxin. The advancement of extracted bee venom for treatment of inflammatory conditions, including but not limited to advanced knee OA and MS is speculative but based on direction provided by prior clinical data.

Apimeds Korea successfully completed Phase I, Phase II, and Phase III trials in South Korea in OA in 2003, at which point Apitoxin was approved by the MFDA to treat pain and mobility in patients with OA.

Note: Net loss and no revenue are for the 12 months that ended June 30, 2024.

(Note: Apimeds Pharmaceuticals US filed an S-1/A dated Dec. 9, 2024, and disclosed the terms for its micro-cap IPO: 3.33 million shares at a price range of $3.00 to $4.00 to raise $11.66 million. Background: Apimeds Pharmaceuticals US filed its S-1 for its IPO on Sept. 25, 2024, with estimated IPO proceeds of up to $12.0 million.)