Yoo Jong-man, CEO of Organoid Sciences discusses the company’s pioneering work in organoid-based regenerative medicine, drug evaluation, and precision medicine. He highlights its regulatory achievements, proprietary technology platforms, global expansion, and Phase I clinical programme for refractory Crohn’s disease. Looking ahead, he aims to establish Organoid Sciences as a global leader and build a broader healthcare ecosystem around organoid technology.
Could you introduce Organoid Sciences and explain the journey that led to its creation?
I began my academic career working with stem cells during my PhD, well before 2015, and became increasingly interested in finding new modalities capable of genuinely regenerating damaged organs. From 2015 onward, I focused specifically on organoid technology, and in 2018 founded the company that would become Organoid Sciences, building it out from 2019. We raised our Series A in 2020, our Series B in 2022, and completed our IPO in May last year, 2025.
The original motivation was twofold: to explore organoids as a genuine regenerative medicine modality, and to develop them as a human-relevant alternative to animal testing, in line with the broader movement toward new approach methodologies. At the time, this remained largely academic work; nobody had genuinely pursued commercialising organoid technology. We set out to change that, and in doing so became something of a pioneer in Korea. As a result, our company was the first in the world to bring organoid-based technology through to regulatory approval.
What are the core pillars of Organoid Sciences’ business today?
We operate across two main business lines. The first is regenerative medicine, using tissue-specific stem cells, cultured through organoid technology, to directly regenerate damaged organs. This grew directly from an observation about earlier stem cell therapy: conventional stem cells simply lacked the efficacy to properly differentiate into and regenerate specific organ types, whereas tissue-specific stem cells, grown as organoids, can.
The second is our organoid-based drug evaluation platform, ODISEI, used to assess efficacy and toxicity, not only for pharmaceuticals but for cosmetics, probiotics, functional foods and veterinary products as well. Built on that same capability, we have also developed a precision medicine offering: taking a sample directly from a patient, generating a patient-specific organoid, and screening it against multiple drug candidates simultaneously, since the growing number of available therapies for a given condition means it is often genuinely unclear which will work best for a specific patient. We now run this through a joint venture with several hospitals, including one of Korea’s leading institutions.
What is the split between these three business lines in terms of revenue, and is the company cash-generating today?
About 80% of our current revenue comes from our drug evaluation platform, since large pharmaceutical and biotech companies are increasingly turning to organoid-based testing, largely from Korean partners so far, though we are now expanding into international pharma relationships as well. Our precision medicine offering, already launched across Korean hospitals, represents a second and growing revenue stream. Regenerative medicine remains our long-term focus, precisely because no other cell therapy modality can genuinely regenerate damaged organs the way tissue-specific organoid-derived stem cells can. We were, in fact, the first company in the world to receive regulatory approval specifically for an organoid therapy, using whole tissue-specific stem cells, as designated by the Korean FDA.
Your two core technology platforms are ATORM and ODISEI. What key bottleneck in organoid technology do they address?
The central challenge in regenerative medicine is direct regeneration, and the cell source used is critical. Tissue-specific stem cells had historically failed to properly differentiate into their target organ type, but growing them as organoids solves that problem, provided you can actually maintain high populations of tissue-specific stem cells at clinical grade, which is genuinely difficult: characterisation is difficult, and scaling is difficult. That is precisely where our strength lies, and it is what has been recognised by regulators. We currently maintain a bank of more than 3,500 organoid lines spanning over 20 different organ types, which allows us to offer genuinely customised solutions, whether a partner wants to understand a mechanism of action or test drug efficacy directly against human-derived samples.
Do you see large pharmaceutical companies building this capability internally, or will organoid specialists like yourselves function more as a CRO layer serving the industry?
Most large pharmaceutical companies can manage simpler, smaller-scale organoid work internally, often in collaboration with academic researchers. But once you move into genuine scale, or toward more complex human-relevant microenvironments, that is where companies like ours come in, standardising and industrialising what would otherwise remain a bespoke academic process.
Scaling has historically been a major challenge in cell therapy. How have you addressed the scale-up and GMP requirements for organoid-based therapeutics?
When we started, nobody had genuinely commercialised organoid technology at clinical grade or at scale, so our focus from the outset was not simply on scaling but on treating this rigorously as a therapeutic platform: standardising culture conditions, media formulation and characterisation to a genuinely clinical standard. That discipline is what has allowed us to extend the same underlying process across other organ types and businesses. It is also, I think, what genuinely distinguishes us from a company that set out purely to be a CRO from day one.
Furthermore, our technological capability in successfully overcoming the challenges of mass-producing organoids has been recognized as a core technology at the national level. In fact, organoid-based regenerative medicine has been designated one of Korea’s National Advanced Strategic Technologies, the same category that covers semiconductors, displays and batteries; within biotechnology specifically, only two areas carry that designation, biosimilars and organoid regenerative medicine, and we are currently the only company holding that certification.
Given the challenges faced by traditional stem cell therapies, how prepared are regulators to assess organoid-based therapeutics, and how have you worked with Korea’s MFDS?
We began engaging regulators on how organoids could function as regenerative medicine back in 2019, and government funding agencies have since supported organoid standardisation work, developing guidelines directly alongside the MFDS. We have maintained monthly communication with the MFDS for roughly three to four years now, giving them a genuinely deep understanding of our manufacturing process and how we construct our organoid systems. I believe that sustained dialogue is precisely what allowed us to move into clinical trials faster than others in this space.
As you look toward international expansion, how do you see agencies like the FDA or the EMA preparing for organoid-based therapeutics?
We have already engaged directly on this. Our product is listed under the ATMP, advanced therapy medicinal product, framework at the EMA as a tissue-engineered product, and we have met with German regulators specifically, since Germany has one of the more developed ATMP regulatory pathways in Europe and has shown genuine enthusiasm in reviewing our data and helping prepare the necessary documentation.
This remains genuinely early-stage work; we have only just received approval from the Korean regulator and are now beginning Phase I. That said, under Korea’s Advanced Regenerative Medicine Act, in place since 2020, we have already treated four patients with our organoid therapy, seeing a complete response rate above 75 percent and full symptom resolution in all four.
Your lead candidate, ATORM-C, has now entered Phase I. What alternative does it offer patients, and how has that shaped your clinical strategy?
Rather than targeting IBD or Crohn’s disease broadly, we are focused specifically on refractory patients. Most existing treatments are biologic antibodies aimed at reducing inflammation to allow the mucosa to heal on its own. But with long-term treatment, response rates decline meaningfully, often by more than 50 percent, for instance with anti-TNF-alpha agents, at which point clinicians must switch or add therapies. Since nearly all of these existing options work by reducing inflammation rather than directly regenerating tissue, our approach is designed as an add-on therapy that drives direct regeneration of the damaged region itself, rather than simply calming inflammation and hoping healing follows. That mechanism has genuine potential beyond Crohn’s disease as well, including post-surgical healing or leaky gut, though as a company we are strategically prioritising indications, including rarer diseases, that may qualify for conditional approval pathways such as RMAT.
How is the Phase I trial designed, and how is ATORM-C administered to patients?
The Phase I design enrols Crohn’s disease patients who have shown at least six months of refractory response to existing biologics, and our therapy is then added on top of that existing treatment. In most of these cases, the underlying drug is still working to some degree, but is simply unable to heal or regenerate the damaged tissue itself, and left untreated, that can progress toward fistulas or other serious complications, which is precisely what we are aiming to prevent. The therapy itself is delivered via colonoscopy: we take a small tissue sample during an initial colonoscopy, generate the organoid from it, and deliver it back into the patient during a subsequent procedure.
As you move from Phase I toward later-stage development, what is your partnership and financing strategy?
We are running this initial Phase I programme ourselves, generating data specifically in this refractory patient population, and we are actively looking for the right partner, ideally one with a genuine strategic interest in IBD or refractory disease more broadly, to help bring the product to market. In parallel, we have already established a presence across multiple regions specifically to support manufacturing and partnership development, including affiliated entities in both the US and Germany. Through our German operation specifically, we have already secured government funding to help advance our organoid therapy toward clinical trials there, which has meaningfully accelerated our programme and our search for partners and key opinion leaders in the region.
You have pursued international expansion at an early stage. How have you financed this growth, including through your KOSDAQ listing?
We began with Korean government funding and venture capital to build the company domestically, and are now publicly listed on KOSDAQ. Financing international expansion remains genuinely difficult, but as with Germany, we have used government funding specifically to offset R&D costs while building partnerships in that market, and we are working to develop genuine revenue models around that, including bringing elements of our technology into other regions. Ultimately, we want the company to stand on its own, but collaboration, funding and partnership remain essential to getting there.
What advantages has building a genuinely next-generation therapeutics company from Korea specifically given you, and what challenges have you had to overcome?
Korea has deep experience in stem cell science dating back to work commercialised around 2018, which means the regulatory science, manufacturing know-how and broader infrastructure needed for this kind of company were already reasonably well established, making it easier to build on that foundation. Korea’s hospital system is also genuinely strong, which makes running clinical trials here considerably easier and faster, and a number of international companies have chosen to run trials in Korea for exactly that reason. Government support for innovative new technology has been a further advantage; Korea’s MFDS, for instance, is actively developing organoid toxicity standardisation, arguably ahead of where the FDA currently stands on this specific question.
The harder part is that Korea still lacks large domestic pharmaceutical companies on the scale of those in the US, Europe or even Japan, which makes it genuinely difficult to find well-capitalised innovation partners willing to lead this kind of collaboration from within the region.
Looking three to five years ahead, what are your key priorities for the company?
Over the next three years, our goal is to establish ODISEI as a genuine global leader, backed by stronger efficacy data and services for international partners. Over five years, we want to be recognised as one of the leading healthcare companies globally, building out a broader ecosystem around organoid technology and adjacent fields.
A number of strong Korean biotechs have emerged in recent years, but many end up being effectively absorbed into the orbit of larger global pharmaceutical companies, which come in and take over much of the value creation. Breaking into a space already dominated by large incumbents is genuinely difficult. What we believe gives newer, genuinely innovative companies like ours real opportunity is precisely that: pursuing technology that is new enough that no incumbent yet owns the category. That comes with real risk, but equally real upside, and I think this is part of why the Korean government is actively looking to support innovative new organisations across diverse fields, not just established players, in search of exactly that kind of opportunity.
What message would you like to leave with investors, pharmaceutical companies and potential partners about Organoid Sciences and its ambitions?
Organoid technology is, in many ways, just the starting point. Today, our two platforms, focused on regenerative medicine and on drug evaluation, represent our core offering, but this technology opens the door to a considerably broader range of applications over time, and we believe an entire healthcare ecosystem will eventually grow up around it. That is precisely why we run conferences and symposiums, to help commercialise the space and build broader awareness of what organoid technology can genuinely achieve, since we believe the market and the ecosystem need to grow together for that to happen. We are deliberately building this network beyond Korea alone; alongside our US and German operations, we are also developing infrastructure in East Asia, including a manufacturing capability in Vietnam that will launch soon. We recognise that genuinely new technology of this kind takes time to mature commercially, much as the internet did in its own early, sometimes turbulent years, and we see ourselves very much at that early stage now. We hope to find the right partners to help us navigate that path and grow the ecosystem together.
Looking further out, over the next decade, our ambition is to build a company that genuinely operates without borders, contributing to human health across multiple fronts, not only in regenerative medicine but also in oncology applications building on the same underlying platform. That broader vision, of what biotechnology can ultimately achieve, is very much what drives him.
