[Edaily Reporter YU JIN-HEE ] Ensol Biosciences (hereinafter “Ensol Bio”), a company specializing in the development of innovative new drugs, is moving full steam ahead with its transfer listing to KOSDAQ. Unlike its previous attempt, which failed due to the review committee’s conservative stance toward new modalities (treatment methods), this renewed effort is backed by tangible results from its core pipeline and strengthened financial momentum, signaling a positive outlook.

Successful Global Phase 3 Clinical Trials and Eased FDA Regulations... Proving Unparalleled Technological Capabilities

According to industry sources on the 29th, Ensol Bio is changing its lead underwriter for its transfer listing from KONEX to KOSDAQ from Hana Securities to Shinhan Investment Securities and is resuming its market push. Having finalized the underwriter change procedures this month, Ensol Bio plans to revamp its listing strategy and reapply for a technology evaluation in the second half of this year.

The industry predicts Ensol Bio’s successful entry into KOSDAQ because, unlike its previous attempts, the company is now thoroughly prepared. The first reason is the successful advancement of its core pipeline into late-stage clinical trials and the firm trust it has earned in the global market. “P2K” (known as SB-01 in the U.S.), the company’s lead pipeline candidate for the treatment of degenerative disc disease, has completed a U.S. Phase 3 clinical trial and submitted the Clinical Study Report (CSR) to the U.S. National Institutes of Health (NIH). Its U.S. partner, Spine BioPharma, is pursuing discussions with the U.S. Food and Drug Administration (FDA) regarding accelerated approval while simultaneously initiating fundraising efforts to prepare for a second Phase 3 clinical trial. Dr. Jeffrey Ro, a renowned U.S. spine surgeon, has identified SB-01 as the future and standard of care for spinal treatment, thereby demonstrating its global value. The global degenerative disc disease market is projected to grow to $50 billion (approximately 69 trillion won) by 2030.

E1K (Engedi 1000), a treatment for knee osteoarthritis and another key product, has also entered the full-scale phase 3 clinical trial phase in South Korea. NGeneBio Co., Ltd. has completed the first patient administration (FPI) for the E1K Phase 3 clinical trial at Samsung Seoul Hospital and has begun full-scale patient recruitment. This trial targets 358 patients with moderate “KL Grade 3” osteoarthritis who do not respond to anti-inflammatory analgesics and have extremely limited treatment options prior to surgery.

E1Corporation is a compound derived from the company’s proprietary AI-based drug discovery system (ESAIDD). It incorporates the company’s unique “Selective Signal Regulation” (SSR) technology, which selectively binds to “TGF-β1” (transforming growth factor-beta 1)—a key factor in osteoarthritis—to block signals that cause cartilage destruction while preserving protective signals. In particular, it has already demonstrated its efficacy as a disease-modifying osteoarthritis drug (DMOAD) through animal studies and its commercialization for companion dogs. A prime example is “Jointvex,” a companion dog treatment with the same molecular structure, which secured marketing authorization after demonstrating an 87.6% clinical improvement rate based on data from 950 dogs over six years.

Furthermore, E1Corporation secured regulatory relief from the U.S. Food and Drug Administration (FDA) during the process of obtaining the final response to its Pre-IND (Pre-Investigational New Drug) application for entry into a local Phase 3 clinical trial. The FDA has previously approved the use of drugs manufactured at facilities compliant with South Korea’s Current Good Manufacturing Practice (cGMP) standards. The criteria for Chemistry, Manufacturing, and Control (CMC) batch data were also significantly relaxed to the level of two finished product lines, and domestic genotoxicity data were officially recognized. As a result, a sound basis has been established to reduce the costs—amounting to hundreds of billions of won—and the time required—spanning several years—for conducting U.S. clinical trials.

Full receipt of advance payments and a 5 billion won capital increase... Financial stability established through 10 billion won in revenue

The company has completely resolved financial uncertainty—the greatest weakness of biotech ventures—and secured solid profitability. This month, Ensol Bio received the full 4 billion won advance payment under the exclusive Korean distribution rights agreement for E1Corporation (valued at 100 billion won based on fixed royalties) signed last March with LEADERS COSMETICS CO.,LTD., a mid-sized domestic pharmaceutical company. Considering that the Korean market accounts for less than 1% of the global market, the value of the global licensing rights is estimated to exceed at least 1 trillion won. The company expects to comfortably achieve approximately 10 billion won in revenue this year, including this domestic advance payment for E1K and the 6 billion won advance payment from the P2K indication expansion agreement. This means that, despite pursuing a technology-based listing, the company has already demonstrated solid revenue performance.

The company has also completed its capital raise, backed by strong support from the capital markets. Ensol Bio carried out a third-party private placement worth 4.9999 billion won, targeting Hyung In-woo, CEO of Smart & Growth—the driving force behind the early growth of Alteogen Inc.(196170)and the company’s largest shareholder. CEO Hyung and his team, having already invested approximately 60 billion won, have further solidified the company’s corporate governance structure with this additional capital injection. The new shares, issued at a price of 10,260 won per share, will be subject to a mandatory one-year lock-up period, thereby fully securing the company’s liquidity and financial soundness ahead of its listing.

Leveraging its expanded financial resources, the company has expanded its platform into the fields of cancer and brain diseases, further enhancing its future value. Ensol Bio has signed a joint development and commercialization agreement with Saehan Industries, a leading South Korean nuclear medicine company, for the peptide radiopharmaceutical (PRC) “D1K,” which targets the non-small cell lung cancer marker Trop-2. This is an innovative platform that overcomes the technical limitations of “linker cleavage”—the greatest challenge facing existing antibody-drug conjugates (ADCs) and peptide-drug conjugates (PDCs). After being taken up into cells, it directly destroys cancer cell DNA using radioactive energy without requiring a separate cleavage process, thereby eliminating the risk of toxicity to normal cells at the source. Flow cytometry (FACS) results demonstrated that D1K exhibited an excellent internalization efficiency of 32.3% in non-small cell lung cancer cells, while no internalization occurred in normal cells, such as amniotic epithelial cells. This confirms its safety. Through this technology, EnsolBio has expanded its footprint into the PRC sector—the core of the global precision medicine market—and into the field of theranostics, which simultaneously enables diagnosis and treatment.

Furthermore, the funds secured through this capital increase will be proactively invested in clinical trial costs for “M1K,” a treatment for Alzheimer’s disease—a key future growth driver—and “C1K,” a treatment for triple-negative breast cancer (TNBC). Currently, business development (BD) negotiations for technology transfer (L/O) with major global pharmaceutical companies are underway for both the osteoarthritis treatment E1K and the oral obesity treatment “H1K.” If significant results are achieved in the future, this is expected to provide even stronger momentum for the company’s push toward an IPO.

Kim Hae-jin, CEO of Ensol Bio, emphasized, “The synergy between Shinhan Investment Securities’ expertise in listing biotech companies and the achievements of our innovative new drug pipeline will enable us to successfully complete this secondary listing and leap forward as a global biotech company.”