[Edaily Reporter YU JIN-HEE ] INGENIA Therapeutics (hereinafter “INGENIA”), considered a promising contender in the initial public offering (IPO) market for the second half of this year, has received approval for its preliminary listing review from the Korea Exchange (KRX) for the KOSDAQ market and is set to begin the full-scale public offering process. INGENIA plans to achieve a successful listing through its unique core technology and proactive, large-scale technology transfer achievements.

Possesses Explosive Potential... Collaboration with Merck Is Key

According to Ingenia’s securities registration statement filed on the 23rd via the electronic disclosure system, the company’s explosive growth potential coexists with the uncertainty inherent in biotech firms.

Injenia’s strongest investment appeal lies in its solid partnership with Merck, a global pharmaceutical and biotech company. In 2022, Injenia transferred the rights to IGT-427, a candidate drug for eye diseases, to the UK biotech firm EyeBio in a deal worth over 1 trillion won. Following Merck’s acquisition of EyeBio in 2024 for up to $3 billion (approximately 4.5 trillion won), IGT-427 was incorporated into Merck’s official pipeline (Merck code name MK-8748) and is currently progressing smoothly through Phase 2b/3 clinical trials.

Merck has designated this compound as one of its “Ten Key Programs,” expected to generate a total market opportunity of over $70 billion (approximately 107 trillion won) by the mid-2030s, and is making a full-scale investment with the goal of commercialization as early as 2030.

Merck is focusing all its efforts on developing MK-8748 as a successor growth driver in response to the loss of exclusivity and patent expiration in the U.S. for its mega-blockbuster immuno-oncology drug Keytruda (KEYTRUDA) in 2028. Starting in 2030, as the product’s commercialization becomes a reality, royalty revenue linked to Merck’s global sales is expected to begin flowing in earnest, serving as a strong pillar to drive Ingenia’s revenue growth.

The driving force behind Ingenia’s selection by a major pharmaceutical company lies in its proprietary platform technology, LCIDEC (Ligand Capture, Internalization, Degradation in EC). The global market for retinal disease treatments, currently valued at approximately $15.8 billion (about 24 trillion won) annually, is dominated by drugs that simply inhibit vascular endothelial growth factors (anti-VEGF), such as Regeneron Pharmaceuticals’ Eylea and Vabysmo from Genentech, a subsidiary of Roche. However, existing drugs had clear limitations: they were less effective for non-responsive patients—who account for about 60% of the total patient population—and were unable to fundamentally halt disease progression.

In contrast, Ingenia’s LCIDEC platform employs a differentiated approach that fundamentally repairs and stabilizes damaged microvascular structures. It utilizes a dual-action mechanism that simultaneously strengthens microvascular structures and draws disease-causing proteins into the cell to break them down and eliminate them.

Ingenia has dramatically increased the drug’s durability, significantly extending the interval between intravitreal injections from an average of 16 weeks to once every 24 weeks, thereby maximizing patient convenience. Thanks to this superior technology, Ingenia has received the highest grade, “A,” in technical evaluations conducted by two specialized assessment agencies.

Unlike biotech startups that attempt special listing based solely on projected future enterprise value, Ingenia has already secured over 50 billion won in cash through upfront technology transfer payments and milestone payments (stage-based royalties), verifying its commercial viability by achieving its first profit since its founding in 2024.

Following the listing, the company plans to pursue a series of global technology exports for IGT-303, a treatment for chronic kidney disease currently under in-house development, based on its proven platform technology. IGT-303, which is currently undergoing Phase 1/2a clinical trials in Australia and New Zealand, will enter into a major partnership with another global big pharma as soon as efficacy data is secured by the end of this year.

A lineup of strong follow-on candidates is waiting in the wings, including IGT-302, a glaucoma treatment for which a preliminary option agreement has been signed and a decision on a full licensing agreement is expected this year.

Risks Associated with Biotech Companies Remain... Overhang Must Also Be Considered

However, the fact that Ingenia’s revenue model is specialized in technology transfer creates the risk that the company’s fate is contingent on the clinical success and business strategies of its partners. The majority of licensing agreements, including the previously signed contract with Merck, are designed with a contingent revenue structure in which most payments—excluding upfront fees—are contingent upon clinical progress and regulatory approval.

If the results of the upcoming Merck-led Phase 3 clinical trial fall short of expectations or if the development schedule is delayed, the scheduled receipt of milestone payments could be significantly pushed back or even become impossible. Investors should exercise caution, as there is also a possibility that contracts could be terminated due to external factors beyond Ingenia’s control, such as a deterioration in a partner’s financial situation or changes in R&D priorities.

In addition, the company faces the risk of customer concentration. According to its securities registration statement, Ingenia estimates that it will record cumulative revenue of $499,668,000 (approximately 750 billion won) from this year through 2029 and maintain a profitable trend. The issue is that these projections include a significant number of anticipated technology transfers with potential customers with whom agreements have not yet been finalized.

If technology transfers in the follow-up pipeline are delayed or fail, causing actual performance to deviate by more than 10% from estimates, the company’s credibility will suffer a fatal blow. As a company eligible for the Technology Growth Exemption, it is exempt from revenue requirements (less than 3 billion won) for five years following its listing. However, if it fails to demonstrate independent financial performance even after the grace period ends in 2031, it could be designated as a “monitored stock” or subject to a substantive review for delisting; therefore, securing long-term financial stability is considered an essential task.

Since Ingenia is a foreign corporation headquartered in the United States, it faces specific administrative and legal risks compared to domestic companies. To remit the approximately 60 billion won raised through this public offering to its U.S. headquarters, the company must submit a securities issuance report to the Ministry of Economy and Finance for approval after the funds are paid in. Failure to obtain government approval in a timely manner could disrupt the execution of global clinical trial funding.

The risk of an “overhang” (existing potential selling pressure) has also been raised. The number of unexercised stock options amounts to 8.75% of the total issued shares following the public offering, which could lead to significant dilution pressure on the stock price in the event of future new share issuances. Since the stake held by major shareholders, including Ingenia CEO Han Sang-yeol, will drop slightly to 20.55% after the IPO, the company has established a defensive barrier by entering into a joint voting agreement with friendly shareholders. However, there remains a risk that management stability could be compromised if their stakes are diluted during future fundraising efforts.

Hong Soon-jae, CEO of Biobook, stated, “Recently, performance-driven companies have been highly valued in the securities market,” adding, “Since Ingenia is going public after demonstrating its profitability and performance, it is likely to attract significant investor interest.”