OncoTherapy Science, Inc.
4564・Growth Market・Pharmaceuticals
Business
OncoTherapy Science was established in 2001, originating from joint research with the Institute of Medical Science, the University of Tokyo, as a research and development-driven biotech venture specializing in the oncology field. The company conducts drug discovery research across three areas—small molecule drugs, cancer peptide vaccines, and antibody drugs—with its core business centered on out-licensing to pharmaceutical companies such as Shionogi & Co. Through its consolidated subsidiary CPM, the company also provides contracted cancer genomic analysis services, including Whole Genome Sequencing Analysis, Neoantigen Analysis, and Liquid Biopsy. Its major customers are medical and research institutions such as the Japanese Foundation for Cancer Research (¥337 million) and Fukuoka Cancer Clinic of the Jisei-kai Medical Corporation (¥96 million), and the company also participates in the Ministry of Health, Labour and Welfare's Whole Genome Analysis Implementation Plan.
Business Model
Revenue consists of (1) upfront payments, milestones, and royalties under partnership agreements with pharmaceutical companies, and (2) contract service revenue from cancer gene analysis and immune analysis handled by CPM. Of the ¥808 million in consolidated business revenue for FY2026 (ending March 2026), analysis service revenue accounted for the majority at ¥806 million, while license revenue remained at only ¥2 million. While continuing to invest ¥534 million in R&D expenses, the company positions the acquisition of milestone revenue through new partnership agreements with pharmaceutical companies as its medium- to long-term revenue growth scenario.
Company Strengths
As of March 31, 2026, the company held 455 patents worldwide. Based on a comprehensive 32,000-gene analysis system using cDNA microarrays developed through joint research with the Institute of Medical Science, The University of Tokyo, the company possesses proprietary drug discovery targets and compound libraries across the fields of small-molecule pharmaceuticals, peptide vaccines, and antibody drugs, forming an intellectual property portfolio that is difficult for competitors to replicate in the short term.
The company has jointly conducted multiple clinical trials with Shionogi & Co., Ltd., including a Phase III clinical trial for esophageal cancer using the peptide vaccine S-588410. It has already concluded a collaboration agreement with a staged revenue structure comprising an upfront payment, milestones, and royalties, and its proven collaborative relationship with a major pharmaceutical company underpins its credibility in negotiations for new partnerships.
CPM has obtained CAP accreditation and ISO/IEC 27001:2022 certification, establishing a high level of reliability in terms of quality and information security. The company has secured continued orders under the Ministry of Health, Labour and Welfare's "Whole Genome Analysis Implementation Plan," and revenue from the Cancer Precision Medicine Business in FY2026 (ending March 2026) reached ¥806 million (up 7.9% year on year), reflecting a stable order base.
ENVALITH's Perspective
Performance Trend
Consolidated business revenue for FY2026 (ending March 2026) was ¥808 million (up 7.8% year on year), a slight increase. This was driven by CPM's analysis service revenue of ¥806 million (up ¥59 million year on year), while license revenue in the pharmaceutical research and development segment remained at only ¥2 million. Operating loss widened slightly to ¥810 million (versus ¥797 million in the prior period), mainly due to an increase in research and development expenses to ¥534 million (versus ¥491 million in the prior period). With an impairment loss of ¥63 million (versus ¥0.3 million in the prior period) recorded as an extraordinary loss, net loss for the period worsened to ¥910 million (versus ¥815 million in the prior period). Looking at the loss trend over the past five periods, losses have narrowed significantly from ¥2,572 million in FY2022, but have remained elevated in the ¥800–900 million range in FY2025 and FY2026, suggesting the loss-narrowing trend has stalled.
Growth Strategy
Strengthening the revenue base through clinical development progress, expanded licensing-out activities, and diversification of CPM's analysis services
Continuing to conduct a Phase I trial in the United States targeting breast cancer patients, including triple-negative breast cancer, with the primary objective of confirming safety and recommended dosage via oral administration. Good oral absorption in humans has already been confirmed through an oral absorption study conducted in Australia. Aiming to expand licensing-out opportunities through the accumulation of clinical data.
Identified a promising kinase inhibitor compound within the company's proprietary compound library as a target for organ fibrosis treatment, and entered into a joint research agreement with NIBN to advance research aimed at licensing it out. Aiming to create new revenue sources through business expansion into disease areas beyond cancer.
In addition to continuing to receive orders under the Ministry of Health, Labour and Welfare's "Whole Genome Analysis Implementation Plan," the company is promoting improved processing capacity through the introduction of long-read sequencing technology and automation of analysis processes. Has begun development of a new cancer gene panel test that can be implemented under insured medical care, and is also considering partnerships with medical device manufacturers and distributors. Aiming for market expansion through achieving insurance coverage.
Entered into a joint research agreement on Liquid Biopsy with Osaka Metropolitan University and WOLVES HAND Co., Ltd., and has begun data collection aimed at establishing indicators for monitoring cancer recurrence in dogs. Aiming to develop new revenue sources by entering the veterinary medicine field, where market expansion is expected due to the aging of pets and advances in medical care.
In addition to continuing and deepening the existing partnership with Shionogi & Co., Ltd., the company is actively pursuing new partnership opportunities. Also strengthening licensing-out activities for antibody drugs, including anti-amyloid beta peptide antibodies. Aiming to reliably advance partnership businesses and secure milestone income through side support and back-office support for clinical development conducted by partners.
Last updated: July 19, 2026