Fundraise

Toregem BioPharma raises $5.3M to advance tooth-regeneration drug into Phase II trials

What's the deal? Kyoto-based Toregem BioPharma has raised $5.3M (¥850M) in a Pre-Series C round to push its experimental tooth-regeneration drug, TRG035, into Phase II clinical trials. The round brings the company's total funding — including grants, subsidies, and equity — past $29M.

TRG035 works by blocking a protein called USAG-1 that suppresses dormant tooth buds in the jaw. By neutralising this biological brake, the drug aims to trigger the body to grow new teeth naturally — a first in medicine if it works.

Investors include existing backer JIC Venture Growth InvestmentsDealroom has a profile for this one. Try Dealroom → and new participants Osaka University Venture CapitalDealroom has a profile for this one. Try Dealroom →, BI Holdings, SHOFU, SIIF Impact CapitalDealroom has a profile for this one. Try Dealroom →, and Chushin Venture CapitalDealroom has a profile for this one. Try Dealroom →.

Why now? The funding follows Toregem's Phase I trial, launched at Kyoto University Hospital in October 2024, which enrolled 30 healthy adult men missing at least one molar. That safety study paved the way for Phase II, which will focus on children with congenital tooth agenesis — a rare condition where permanent teeth never develop.

These children have few good options today. Their jawbones are still growing, making implants and dentures impractical until adulthood. The condition can affect nutrition and quality of life, creating urgency for a curative approach.

What could go wrong? The science is ambitious but early. Blocking a protein involved in bone and tooth development carries risks of unintended effects elsewhere in the body. Phase I tested only safety in adults; proving efficacy in children is a far higher bar.

Regulatory timelines for novel biological therapies are long and unpredictable. Toregem also plans to expand trials to the US, adding another layer of regulatory complexity.

The signal: Toregem's investor mix — spanning government-backed JIC Venture Growth Investments, university venture capital, and impact-focused SIIF Impact Capital — reflects a pattern increasingly common in Japanese biotech, where public innovation ecosystems co-invest alongside private capital to de-risk early-stage science. The company's "breakout" growth stage, per Dealroom, suggests it is crossing from pure research into commercial viability, a transition that could attract larger international rounds as it prepares US trials.

Read more: economictimes.indiatimes.com

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