S-Alpha Therapeutics, Inc., a digital therapeutics expert, eyes an IPO in late 2025, with LigaChem Biosciences Inc. joining as SI
｜[Interview] Choi Seung Eun, CEO of S-Alpha TherapeuticsTherapeutics
｜S-Alpha Therapeutics technology secures alignment from patents globally to development of digital therapeutics including Software as a Medical Device (hereinafter SaMD) for treatment and digital healthcare solution, and digital medicine
[by Lee, Young Sung] S-Alpha Therapeutics, Inc., (hereinafter referred to as S-Alpha Therapeutics), specializing in digital therapeutic devices (DTx), plans to seek an initial public offering (IPO) for the KOSDAQ technology special listing, initiating a preliminary review from the Korea Exchange by the end of 2025.
The company reportedly demonstrated its technological expertise by strategic partnership of overseeing clinical development, sales, and marketing for digital therapeutics in Key Asian countries with its SAT-001 technology to Rohto Pharmaceuticals Co, Ltd. , a Japanese firm covering majorly ophthalmology disease area and Skin care business globally, last month. While the exact shareholding details remain undisclosed, Rohto Pharmaceuticals has opted for further strategic investment (SI) in S-Alpha. Prior to this, Korea's LigaChem Biosciences (formerly LegoChem Biosciences), renowned for the development of new ADC (antibody-drug conjugate) drugs, also made strategic investments, garnering significant attention.
Seung Eun Choi, CEO of S-Alpha Therapeutics, disclosed plan of IPO promotion schedule during an interview with at the company's headquarters in Gangnam district, Seoul.
"We intend to undergo a technology evaluation early next year and are aiming to go public by the end of next year at the earliest," Choi said. Samsung Securities has been appointed as the listing manager, with a preliminary review scheduled for this year.
The Digital Therapeutics SAT-001, being developed by S-Alpha Therapeutics, is technology of investigational software treatment device designed to assist patients with personalized rehabilitation, treatment, and physical strength enhancement activities. Typically accessed through smartphone or tablet applications, it operates akin to medicine, complementing long-term prescriptions from doctors, typically spanning 3 to 6 months.
Especially, in South Korea, the DTx market remains in its developing status, with approval granted to four products, for sleep disorder, visual disturbance after stroke and for Chronic Obstructive Pulmonary Disease.
◇Rohto Pharmaceutical Co, Ltd., signs an agreement with S-Alpha Therapeutics following thorough due diligence
On March 28, S-Alpha Therapeutics inked a licensing agreement with Rohto Pharmaceutical for its pipeline technology 'SAT-001'. Simultaneously, Rohto Pharmaceutical's decision to increase paid-in capital was announced concurrently. Details regarding the inheritance size, upfront payments, and milestones remain confidential. The SAT-001 technology has undergone proof-of-concept (PoC) studies in South Korea, confirming its safety and effectiveness through preliminary clinical trials.
"We started the pivotal clinical trial of SAT-001 in October last year in South Korea, with the first patient - in December. Currently, over 50% of the target number of participants are enrolled across 12 clinical sites, with Gachon University Gil Hospital serving as the Coordinating Investigator (CI)," Choi stated.
Rohto is a healthcare company in Osaka, Japan, celebrating 125 years in business. With "health" as its core business value, the company is not only expanding its cutting-edge life science research and business, such as in the field of regenerative medicine, based on its Health & Beauty business, but also pursuing essential health that draws out the power of human beings, and challenging not only functional foods but also food business such as primary industry and restaurants.
The bond between S-Alpha Therapeutics and Rohto Pharmaceuticals is unique. It originated last year when Choi proposed fostering employee and company growth by encouraging the unconditional sharing of ideas, emphasizing collective intelligence as a core corporate culture. While technology transfer is a common form of commercialization in biotechnology, S-Alpha Therapeutics welcomed new ideas from employees without restricting the commercialization of digital therapeutic devices.
The connection with Rohto Pharmaceuticals started with Kim Kyunghee, head of clinical research and development, leveraging her long experience with Japanese companies. Following a presentation in Japan and several months of due diligence, a technology transfer deal was sealed.
"We entered into a Confidential Disclosure Agreement (CDA) and underwent impressive due diligence by Rohto Pharmaceuticals for several months, assessing S-Alpha's patents, mechanism of action, Korean clinical trials, product feasibility considering regulation globally, and GMP certification as well as potential of business globally. Rohto Pharmaceuticals expressed interest in our entire pipeline, leading to the agreement," Choi clarified.
◇SAT-001, technology of an investigational Software as a medical device(SaMD) under development in South Korea as a 'pediatric myopia treatment'
SAT-001, technology of an investigational software as a medical device, is specifically targeted at addressing pediatric myopia in accordance with DTx development guidelines in South Korea. While its development as a pediatric myopia treatment is progressing in South Korea, plans for its commercialization globally will be planned according to specific regulation requirement and strategy. In addition, given Rohto Pharmaceuticals’ expertise in ophthalmology, it is expected that commercialization efforts will be more encouraged and performed strategically globally
Considering key technology of SAT-001, using the smartphone’s camera, eye movements are tracked, synchronizing with character movements within the application. S-Alpha Therapeutics incorporates this tracking technology, enhancing myopia treatment efficacy.
SAT-001 is a DTx for pediatric myopia patients in South Korea so that its UX/UI were well designed from the beginning of development for children to engage with SAT-001. We expect that this product philosophy will be able to increase the satisfaction of not only patients, but also HCPs and guardians, through continuous updates even after actual market launch.
◇S-Alpha's unique development and product technology, patent registration globally
"S-Alpha's Distinctive Development and Product Technology: Patents Registered in Korea, Japan, and the United States and key countries, considering strategy of commercialization."
S-Alpha’s technology is primarily divided into two categories: development technology and product technology. Development technology involves data processing, including the analysis of ‘big data’ such as server data as well as validation of clinical data to increase the efficacy of software treatments as well as validation of platform technology for software development. Product technology originated from development technology enforce of efficacy and optimization of software SAT-001, SAT-003, and SAT-008.
SAT-001, for instance, has been patented to ensure minimal physiological and anatomical differences in subjects, irrespective of monitor size, through calibration technology integrated with tracking technologies. In addition, more than three technology patents, covering data processing and mediation, have been filed in Korea, Japan, and the United States, including key nations considering commercialization.
SAT-003, another product technology, is software designed to address cancer cachexia. The plan of clinical trials with SAT-003 has been approved from the Ministry of Food and Drug Safety in South Korea and is currently undergoing pilot clinical trials for conceiving of proof of concept at Dongguk University Il-San Hospital, located in Il-San in South Korea. SAT-008, on the other hand, is a digital device aimed at immune enhancement. Clinical trials were conducted at Seoul National University Bundang Hospital and Korea University Anam Hospital, with 510(g) feedback suggesting pathways 'wellness products'. In USA
◇S-Alpha Therapeutics secures approximately KRW 23 billion in investment; LigaChem Biosciences Inc. joins in strategic investment in early time of company
S-Alpha Therapeutics has successfully secured around 23 billion (approximately USD 16.6 million) in investment through Seed (2021), Series A (2022), and Series B (2023). Notably, the company received a Strategic Investment (SI) from LigaChem Biosciences Inc. shortly after its establishment in 2019.
To date, the investment organizations include Korea Investment Partners, Devsisters Ventures, Hana Ventures, Tony Investment, STIC Investment, LB Investment, AJU IB Investment, Mirae Asset Capital, SJ Investment Partners, Kiwoom Investment, KDB Capital, StoneBridge Ventures, CJ Investment, and others.
Series C funding is underway. Once secured, the company plans to initiate additional clinical trials, including those in the United States.
"The DTx market represents not just a fleeting trend but a new technology poised for further growth upon future commercialization," Choi underlined. "S-Alpha Therapeutics remains committed to expanding its pipeline to incorporate DTx, aiming to assist patients and medical professionals in need of related treatments," she added.
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News source : THEBIO
