InscoBee, Subsidiary Pursues Nasdaq Listing "Accelerating Phase 3 Clinical Trials... Targeting 30 Trillion Won Market"

[Asia Economy Reporter Lee Seon-ae] InscoBi has effectively succeeded in raising Series A investment from a global investment bank (IB) and plans to accelerate the Phase 3 clinical trial in the U.S. for a multiple sclerosis treatment drug in a market worth 30 trillion won. The company is also pursuing a listing on the Nasdaq market.

According to InscoBi on the 30th, ApimezUSA was valued at $100 million (approximately 120 billion won) in the Series A funding round. For Series A, a U.S. bio-specialized investment bank, Company A, decided to invest up to $8 million (1 billion won).

With this investment, ApimezUSA is expected to gain momentum in advancing the U.S. FDA Phase 3 clinical trial for the multiple sclerosis (MS) treatment drug Apitox. The Phase 3 trial will be conducted in two sets at about 20 clinical centers across the U.S., targeting approximately 500 MS patients, with a 6-month interval between sets. The trial is expected to start as early as November and conclude by February 2023.

ApimezUSA has been in long-term discussions with Company A to secure funding necessary for the Phase 3 trial, efficiently conduct the clinical trial, and establish collaborative frameworks with global pharmaceutical companies. Both parties have finally agreed that dividing the funding into a small-scale private first round and a large-scale public second round (such as an IPO) is the most effective deal structure to raise necessary funds aligned with clinical expenditure timing and to increase valuation at each funding stage.

Accordingly, ApimezUSA plans to raise a total of $60 million in two stages of funding with Company A to proceed with the Phase 3 trial. Additionally, they have signed a ‘lead underwriter package agreement’ that enhances collaboration possibilities with pharmaceutical companies through a Nasdaq listing. Company A will serve as the lead underwriter for △the current Series A-type first funding △and the remaining second funding through a Nasdaq IPO in the first half of next year.

The company stated, “Since establishing the U.S. corporation last year, we have held meetings with over 100 institutional investors and global pharmaceutical companies to raise funds for the Phase 3 trial,” adding, “It is significant that a startup like ApimezUSA has raised a large-scale fund through Series A on Wall Street.”

Company A highly evaluated Apimez and Apitox for △being a substance already commercialized in Korea as the first natural new drug Apitoxin, proving safety and efficacy △the rarity of being a natural product-based new drug candidate that has reached Phase 3 △and the pipeline’s expandability, starting from natural bee venom-based treatments for osteoarthritis (OA) and multiple sclerosis (MS) to other autoimmune diseases.

A company official said, “Specific details about Company A cannot be disclosed due to confidentiality agreements, but we plan to announce them once the first phase of investment payment, expected around the end of October, is completed,” adding, “Apitox is a new drug substance approved by the U.S. FDA for Phase 3 clinical trials (IND) as a representative intractable autoimmune disease treatment for multiple sclerosis, and all preparations for Phase 3 have been completed, so we plan to proceed quickly with the trial.”

He continued, “Apitox will not only be a groundbreaking natural new drug meeting the unmet medical needs of 2.5 million MS patients worldwide but will also expand indications to other autoimmune diseases based on this,” and added, “We expect Apimez to be recognized as a global bio new drug company in earnest.”

This content was produced with the assistance of AI translation services.