Overview

Apimeds Pharmaceuticals US, Inc. is a clinical-stage biopharmaceutical company focused on developing Apitox, a proprietary bee venom-based toxin, for the treatment of inflammatory conditions such as osteoarthritis (OA) and multiple sclerosis (MS) in the United States. Apitox is currently marketed and sold by Apimeds, Inc. in South Korea under the name “Apitoxin” for the treatment of inflammation and pain management associated with OA.

Our Product Candidate

Apitox is a purified, pharmaceutical-grade venom of the Apis mellifera, or honeybee, which is classified by the U.S. Food and Drug Administration (FDA) as an active pharmaceutical ingredient (API). Apimeds Korea has developed a proprietary method and process of turning extracted bee venom into a lyophilized powder for reconstitution prior to intradermal dose injections, which they sell in Korea as South Apitoxin. Apimeds Korea has exclusively licensed to Apimeds Pharmaceuticals US, Inc. all rights to develop, commercialize, market, and sell Apitoxin as “Apitox” in the United States in exchange for a sales royalty.

Financial Results

Since inception, Apimeds Pharmaceuticals US, Inc. has incurred significant operating losses. For the years ended December 31, 2024 and 2023, the company’s net loss was $1,389,990 and $777,694, respectively. As of December 31, 2024, the company had an accumulated deficit of $4,391,924, a stockholders’ deficit of $1,358,121, and a working capital deficit of $1,011,277.

Going Concern

The company has evaluated its ability to continue as a going concern and has determined that its existing cash as of December 31, 2024, is not sufficient to satisfy its operating cash needs for 12 months from the issuance date of the report. The company’s success is dependent on obtaining the necessary regulatory approvals for its product candidates, marketing its products, and achieving profitable operations. The continuation of the research and development activities and the commercialization of its products, if approved, are dependent on the company’s ability to successfully complete these activities and obtain additional financing.

Results of Operations

Operating Expenses

Metric	2024	2023	Change
Research and development expenses	$0	$98,544	$(98,544)
General and administrative expenses	$1,275,095	$648,892	$626,203
Loss from operations	$(1,275,095)	$(747,436)	$(527,659)

Research and development expenses decreased by $98,544 in 2024 compared to 2023 as the company was not performing any R&D activities in 2024. General and administrative expenses increased by $626,203, primarily due to increases in professional services and payroll expenses.

Other Expenses

Metric	2024	2023	Change
Interest income	$2,824	$7,811	$(4,987)
Interest expense	$(117,719)	$(38,069)	$(79,650)
Net loss	$(1,389,990)	$(777,694)	$(612,296)

Other expenses increased by $84,637, mainly due to an increase in interest expense.

Liquidity and Capital Resources

The company has generated no revenue and expects to continue incurring significant operating losses. It is dependent on obtaining necessary equity and/or debt financing to continue operations. The company cannot assure that additional financing will be available on acceptable terms or at all.

Cash Flows

Metric	2024	2023	Change
Net cash used in operating activities	$(733,526)	$(627,790)	$(105,736)
Net cash used in investing activities	$0	$0	$0
Net cash provided by financing activities	$326,500	$1,032,100	$(705,600)
Net (decrease) increase in cash	$(407,026)	$404,310	$(811,336)

The increase in net cash used in operating activities was primarily due to the increase in net loss. Financing activities provided less cash in 2024 compared to 2023.

Outlook

Apimeds Pharmaceuticals US, Inc. faces significant challenges in its ability to continue as a going concern. The company’s success is dependent on obtaining regulatory approvals, marketing its products, and achieving profitable operations, which will require additional financing. There is no assurance that the company will be able to obtain the necessary financing on acceptable terms or at all.