SanBio Company Limited's newly launched regenerative therapy for chronic motor paralysis following traumatic brain injury went on sale in Japan in May, priced at ¥72.7mn per treatment. Four months later, the company's own guidance shows the therapy has yet to reach a single patient: SanBio is targeting only six cases by the fiscal year-end in January, spread across eight hospitals anchored by five universities, Hokkaido, Tokyo, Yokohama City, Osaka and Okayama. (SanBio's SB623 Therapy Reaches Market at ¥72mn, But Revenue Stays at Zero)
The Tokyo-listed company's half-year results, released September 17, confirm zero revenue booked from the drug so far. Research and development spending, most of it tied to the therapy's manufacturing, ran to ¥1.23bn over the six months, down from ¥1.35bn a year earlier. The operating loss widened slightly to ¥1.91bn from ¥1.89bn, while the interim net loss narrowed to ¥1.79bn from ¥2.00bn. Cash and deposits fell ¥2.34bn over the six months to ¥12.75bn. The full-year net-loss forecast stands at ¥5.13bn.
| Metric | H1 last year | H1 this year | Full-year forecast |
|---|---|---|---|
| Operating loss | ¥1.89bn | ¥1.91bn | ¥5.23bn |
| R&D expense | ¥1.35bn | ¥1.23bn | ¥4.11bn |
| Net loss | ¥2.00bn | ¥1.79bn | ¥5.13bn |
Behind the case count, SanBio is rebuilding its supply chain around Japan. Minaris Advanced Therapies is shifting upstream manufacturing steps to its Yokohama plant after closing its Mountain View, California facility, and SanBio has signed a trial-manufacturing agreement with JCR Pharmaceuticals aimed at commercial-scale production. Management describes this as making Japan the company's manufacturing base for eventual expansion into the United States.
On the clinical side, the US Food and Drug Administration has agreed with SanBio on a Phase 3 trial design for the traumatic-brain-injury indication, and the company is preparing to begin that trial next year. Separate programs for chronic cerebral infarction and cerebral hemorrhage remain earlier stage, with SanBio still due to discuss trial designs with Japan's Pharmaceuticals and Medical Devices Agency.
The gap between a priced, approved therapy and an actual patient is what investors are watching. SanBio's efficacy data, from the TBI-01 Phase 2 trial, showed a statistically significant improvement in motor function at 24 weeks for patients who received the cell therapy versus sham surgery (p=0.0401), the basis regulators used for conditional approval in 2024. Whether that clinical result becomes paying cases this fiscal year depends on the eight target hospitals finishing onboarding and SanBio's rebuilt supply chain delivering cells on the day a patient is scheduled for surgery.