Ingenia Therapeutics, a clinical-stage biotechnology company pioneering next-generation vascular-targeted therapies, announced that the company has received approval from the KRX to proceed with its Initial Public Offering (IPO). The move marks a pivotal transition for the company, supported by a robust pipeline that includes two clinical-stage assets, one of which is IGT-427 (now called MK-8748), an investigational bi-specific antibody (Anti-VEGF/TIE2), for patients with retinal diseases being developed by Merck (known as MSD outside of the US and Canada).
Restoring the vascular barrier by direct TIE2 activation
Ingenia’s proprietary platforms, TIE-body and LCIDEC (Ligand Capture & Internalization into Endothelial Cells), are built upon a fundamental breakthrough in vascular biology: the unique, direct activation of the TIE2 pathway. Unlike traditional approaches that rely on balancing ligands (Ang1/Ang2), Ingenia’s technology directly binds and activates TIE2 receptor independent of the ligands. This mechanism effectively “seals” endothelial cells in the vasculature and restores the vascular barrier for conditions characterized by chronic vascular inflammation and microvascular damage.
A diversified clinical and strategic portfolio
The company’s growth is driven mainly by two clinical programs:
- Ophthalmology: MK-8748 (Tiespectus) is an investigational, bispecific antibody (Anti-VEFG/TIE2) advancing into Phase 3 clinical development across both wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) this year, with the potential to redefine treatment across retinal diseases. By directly activating TIE2 to stabilize retinal vasculature, MK-8748 aims to improve outcomes over existing standard of care. In 2022, Ingenia entered into a research collaboration and licensing agreement with EyeBio, a wholly owned subsidiary of Merck following the acquisition in 2024.
- Chronic Kidney Disease (CKD) – Leveraging the same vascular-stabilizing principle, IGT-303 is progressing through Phase 1/2a trials. It addresses the critical unmet need in CKD and Diabetic Kidney Disease (DKD) by recovering glomerular and tubular endothelial layers and slowing disease progression.
Beyond these clinical programs, Ingenia is aggressively expanding its proprietary pipeline into high-value therapeutic areas, including Oncology (normalizing tumor vasculature to enhance immunotherapy), CNS (restoring the blood-brain barrier), and Cardiovascular & Pulmonary diseases.
“The decision to pursue a KRX listing is a strategic milestone that reflects Ingenia’s deep roots and our commitment to global innovation,” said Sangyeul Han, PhD, CEO of Ingenia Therapeutics. “We are at a defining moment. With one asset advancing into Phase 3 this year by our global pharmaceutical partner, Merck and a second asset entering Phase 2a trial for CKD/DKD, our direct TIE2 activation technology has the potential to meaningfully advance the treatment of vascular-driven diseases. We believe this IPO will provide the capital necessary to scale our platform and accelerate the delivery of these life-changing therapies to patients.”
“Targeting TIE2 remains one of the most compelling strategies for managing multiple retinal diseases, and the complexity of the pathway may have limited prior efforts. Ingenia’s ability to trigger ligand-independent activation of the TIE2 pathway, while also inhibiting VEGF signaling, holds promise of becoming a clinical breakthrough. As MK-8748 enters Phase 3 trials this year, we are aiming to demonstrate a meaningful shift in how exudative retinal diseases can be managed, and uniquely stabilized.” Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas and Chair of Research for Retina Consultants of America.
About Ingenia Therapeutics
Ingenia Therapeutics is a clinical-stage biotechnology company focused on developing first-in-class therapies that restore the vascular stability. Headquartered in Watertown, MA, USA, with operations in South Korea and Australia, the company leverages its expertise in antibody engineering to target the TIE2 pathway across ophthalmology, nephrology, oncology and other high-value therapeutic areas, including CNS and Cardiovascular & Pulmonary diseases.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of applicable securities laws, including, without limitation, statements regarding INGENIA Therapeutics’ business strategy, research and development plans, clinical trial initiation and completion timelines, regulatory submissions and approvals, commercialization plans, anticipated milestones, projected financial performance, expected revenue, including potential milestone, royalty, or other payments from existing or future collaborations with Merck, Eyebio, or other partners, and the Company’s plans and prospects relating to a potential initial public offering and public listing in the Republic of Korea.
Forward-looking statements are based on the Company’s current expectations, assumptions, estimates, and projections and are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: risks inherent in the discovery, development, and commercialization of pharmaceutical product candidates; uncertainty of preclinical data and clinical trial results; the timing, cost, and outcome of regulatory review by applicable authorities; the Company’s ability to obtain and maintain intellectual property protection; manufacturing and supply chain risks; competition; the Company’s ability to successfully establish, maintain, and realize anticipated benefits from strategic collaborations, including collaborations with Merck and Eyebio; the amount and timing of any milestone, royalty, or other payments under such agreements; the Company’s dependence on third parties; the need for additional capital and the availability of financing; and risks related to general market, economic, and industry conditions.
In addition, statements regarding a potential public offering and listing in Korea are subject to risks and uncertainties, including, without limitation, market conditions, investor demand, regulatory review and approval processes, compliance with listing requirements of the Korea Exchange (KRX), and the Company’s ability to meet applicable financial, corporate governance, and disclosure standards required of a listed company. There can be no assurance that the Company will successfully complete a public offering or listing in Korea, that any such listing will be approved by the KRX, or that the Company will operate successfully as a publicly traded company.
There can be no assurance that any product candidate will successfully complete development, obtain regulatory approval, achieve commercial success, or generate revenue. Likewise, there can be no assurance that anticipated revenue from collaborations will be realized as expected, or at all. For purposes of the Financial Investment Services and Capital Markets Act of Korea (“FSCMA”), these forward-looking statements are provided in good faith based on information currently available to the Company and are subject to change due to uncertainties and risks beyond the Company’s control. Korean counsel to confirm inclusion of statutory safe-harbor references under Articles 125 and 162 of the FSCMA and any related Enforcement Decree provisions. This press release is not an offer to sell or a solicitation of an offer to buy securities in Korea or in any other jurisdiction. Any offering of securities in Korea will be made only pursuant to a securities registration statement filed with the Financial Services Commission and in compliance with applicable KRX listing regulations. Korean counsel to confirm appropriate legend language for pre-listing communications.
Forward-looking statements speak only as of the date of this press release. INGENIA Therapeutics undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.
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