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Cerecin, a company developing a drinkable dementia treatment, is taking on the challenge of becoming the first fully foreign company to be listed on the KOSDAQ. After failing to pass the technical evaluation in 2022, this is its second attempt. Unlike the previous attempt, the company now has two additional non-clinical-stage assets alongside its lead pipeline tricaprilin.

Until now, foreign companies that were listed or attempted to be listed on the KOSDAQ either had a Korean parent company or were founded by Koreans – clear links to Korea. In contrast, Cerecin is foreign in every aspect – its founder, management, and headquarters – giving the company symbolic significance.

Edaily met with Cerecin’s CEO Charles Stacey and CSO Samuel Henderson to hear why the company is aiming for a KOSDAQ listing.

Shareholder Composition: Nestlé 60%, Korean Investors 29%

On May 9 at Lotte World Tower in Songpa-gu, CEO Stacey said, “We feel a great sense of responsibility about becoming Korea’s first fully foreign-listed company. For various reasons such as shareholder composition, clinical plans, target dementia patient group, and drug production site, establishing a base in Asia is the right decision. The KRX’s technology special listing program is a very attractive option for companies with technological competitiveness before achieving revenue.”

He added, “The target patients for tricaprilin, Cerecin’s investigational dementia treatment, are APOE4 non-carriers, and this population proportionally makes up a larger segment in Asia. In addition, strategic investors such as Singapore-based Wilmar Group and Malaysia’s IOI Group are located in Asia, and with Korean investors collectively holding a 29% stake, listing on the KOSDAQ is a logical choice.”

Cerecin’s shareholding structure consists of approximately 60% by U.S. food company Nestlé, around 10% by Wilmar Group, and 29% by Korean investors. Upon completing its current pre-IPO funding round worth KRW 40 billion by the end of this month, there may be minor changes in shareholding ratios.

According to CEO Stacey, Cerecin received its first domestic investment in 2004 from POSCO, which still holds a partial stake. Other Korean investors include KNT Investment, SK Securities, Hana Securities, Partners Investment, Arche Investment, Shinhan Investment Corp, IBK Capital, KB Securities, M Capital, Medici Investment, and Cheongdam Investment. The company has raised a total of KRW 46 billion in Korea so far.

In the current pre-IPO round, about 80% of funding will come from financial investors (FIs) such as BNK Investment & Securities and Hanwha Investment & Securities. The remainder is expected to come from existing strategic investors (SIs) Nestlé and Wilmar.

Following the fundraising, Cerecin plans to file for a preliminary review for the KOSDAQ listing next month. Hana Securities and Samsung Securities are co-lead underwriters. All IPO shares will be newly issued.

Founded in 2001 as Accera

Cerecin was originally established in 2001 in Colorado, U.S., based on technology transferred from Dr. Henderson, and was known as Accera. CSO Henderson, the scientific founder, holds a Master’s in Biology from the University of Washington, a Ph.D. in Molecular Genetics from the University of Chicago, and completed postdoctoral research in Developmental Biology at the University of Wisconsin.

Accera initially collaborated with Purina, Nestlé’s pet food subsidiary, to develop feed that improved cognitive function in companion animals. In 2004, it secured investment from Inventages, an investment firm under Nestlé. In 2012, it also received investment directly from Nestlé’s headquarters.

“Nestlé is not just a food company, but a comprehensive nutrition company,” said Stacey. “It invests in companies addressing issues such as peanut allergies and gastrointestinal diseases – those with ties to nutritional science, relatively safe R&D, and large population applications. The investment in Accera aligns with that philosophy.”

Stacey joined Accera as a professional manager. He holds a BSc in Neuroscience from University College London, an MBBS from King’s College London, an MSc in Neuropsychiatry from Imperial College London, and an MBA from London Business School. He worked as a surgeon with the UK’s NHS from 2002 to 2009 and was an investor at Inventages from 2010 to 2014. He has served as CEO of Cerecin since February 2015.

Accera faced a setback with underwhelming results in its 2017 Phase 3 clinical trial. However, it succeeded in securing investment from Singapore’s Wilmar Group in 2018, established a subsidiary in Singapore, and rebranded as Cerecin.

This is not Cerecin’s first KOSDAQ attempt. In 2022, it failed to pass the technical special listing due to receiving A·BBB ratings. While that would suffice for domestic biotech firms, foreign companies need A·A grades. Since then, the company has expanded its pipeline beyond tricaprilin (CER-0001) by in-licensing two preclinical candidates, CER-022 and CER-081. In December last year, it obtained the necessary A·A grades from the Korea Technology Finance Corporation and E Credible.

Targeting APOE4 Non-Carriers: A Brain Metabolism Treatment Based on Ketosis

Cerecin’s lead asset tricaprilin is a low-molecular-weight form of caprylic triglycerides developed as a pharmaceutical. It improves cognitive function by supplying ketone bodies, a brain energy source that can substitute for glucose. This mechanism differs from commonly targeted pathways such as amyloid beta or tau, making it unique.

“Various drugs are being developed based on hypotheses involving amyloid beta, tau, and APOE4 to treat Alzheimer’s disease,” said Stacey. “As with oncology where multiple drugs with clinical rationale are used, physicians will need a toolbox of therapies for dementia.”

He added, “Alzheimer’s develops silently and asymptomatically over 20 years, highlighting the importance of preventive treatments. No physician would prescribe a drug with serious side effects to an asymptomatic person. Although further clinical trials are needed, tricaprilin is likely to be safe enough to serve as a preventive medicine.”

Currently, tricaprilin is undergoing clinical trials for patients with mild to severe dementia, with a specific focus on APOE4 non-carriers among Alzheimer’s patients.

“While the presence of APOE4 increases Alzheimer’s risk, 45%–60% of patients are APOE4 non-carriers,” he noted. “In Phase 2 trials, tricaprilin showed significant cognitive improvement in APOE4 non-carriers. If approved, it will be a precision medicine for this patient group.”

He further explained, “Proportionally, APOE4 non-carriers are more common in Asia. Korea, in particular, offers excellent clinical infrastructure, high population density, and proactively screens all dementia patients genetically – making it an ideal location for trials targeting this group.”

Global Phase 3 to Start Year-End · Commercialization in 2029

Funds raised via KOSDAQ will be allocated to the Phase 3 trial and global commercialization of tricaprilin.

“We’ve invested about USD 200 million (KRW 300 billion) in developing tricaprilin so far, and expect to need another USD 100 million (KRW 140 billion) to reach commercialization,” said Stacey. “The global Phase 3 trial starting year-end will recruit 535 patients across 80 sites in Australia, Singapore, Korea, Canada, and the U.S., with potential expansion to Taiwan and the U.K. Development cost per patient is expected to be USD 100,000 (about KRW 140 million).”

He added, “We plan to complete the Phase 3 trial by 2028 and seek global regulatory approval starting with the U.S. FDA in 2029. We’ve filed over 200 patents globally, valid until 2040, with additional filings underway.”

The company is also concurrently conducting R&D on two additional non-clinical-stage pipelines. These include CER-022, a technology introduced from the University of Alberta in Canada in 2023, and CER-081, introduced from Boston Scientific in 2024.

CER-022 is a ketone positron emission tomography (PET) radioligand. It can measure ketone metabolism and is expected to be used for diagnostic purposes in neurology, cardiology, and oncology. CER-081 is an intravenous formulation of beta-hydroxybutyrate solution. It delivers ketones directly via IV injection to acute patients such as those with traumatic brain injury, stroke, or heart failure. Alongside the existing oral formulation, tricaprilin, it is expected to be used in hospital settings.

CEO Stacey stated, “Cerecin’s valuation upon listing will be benchmarked against other biotech companies conducting Phase 3 clinical trials for Alzheimer’s treatments,” and added, “These include Korea’s AriBio, as well as overseas companies such as Alzheon, NKGen Biotech, Prothena, and Anavex Life Sciences.”