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TME Pharma returns to its roots, looks to Japan to rescue NOX-A12

It is a remarkable return to its core business: TME Pharma wants to bring its drug candidate NOX-A12 back into clinical development. To that end, the company has signed an exclusive negotiation agreement with Japan’s TMS Co. Ltd. The focus is on the worldwide development and commercialization of the drug for glioblastoma, a particularly aggressive brain tumor. TMS intends to establish a subsidiary to finance the project and organize further clinical development.

For TME Pharma, this would be an important step back toward where the company’s story began. Behind its current name is the former NOXXON Pharma, a Berlin-based biotech company that made a name for itself with its own class of therapeutic molecules, known as L-RNA aptamers. Lead candidate NOX-A12 was designed to alter the protective environment around tumors and thereby improve the effectiveness of other cancer therapies.

The deal: The financial terms now outlined initially sound quite attractive. Upon signing the definitive agreement, TME Pharma would receive approximately €10 million in near-term consideration, combining cash with equity and debt interests in the new subsidiary. This would be supplemented by more than €100 million in potential regulatory and commercial milestone payments, plus royalties of 8% to 10%. TME Pharma cites potential peak sales of around $1 billion. The company would also receive a share of potential sublicensing proceeds.

However, the agreement is still a long way from a completed licensing deal. Initially, TMS will receive six months of exclusivity for €150,000, during which TME Pharma cannot negotiate with other potential partners over NOX-A12. The financial terms outlined remain nonbinding. TMS must also arrange financing for the new subsidiary. Only once the definitive agreement is in place and funding for clinical development is available can the planned Phase 2 study get underway again.

Backstory: The story stretches back many years. NOXXON Pharma originally set out to develop so-called mirror-image oligonucleotides, or L-RNA aptamers. These artificially produced molecules can bind to certain signaling molecules and proteins with high specificity. NOX-A12 blocks the chemokine ligand CXCL12, which plays an important role in shielding cancer cells from the immune system within the tumor microenvironment. Another candidate, NOX-E36, inhibits CCL2 and related chemokines and has been investigated for inflammatory and fibrotic diseases, among other indications.

Development was capital-intensive from the outset, however. NOXXON repeatedly had to carry out smaller financing rounds and capital transactions to keep its clinical programs alive. As early as 2018, then-CEO Aram Mangasarian said additional capital was needed in the short term, first to secure clinical data and subsequently to finance the NOX-A12 glioblastoma study. Financing remained a recurring issue in the years that followed. The 2019 annual report, for example, documented that the company had fallen well short of its own financing targets.

In July 2022, NOXXON Pharma finally became TME Pharma. The new name was intended to underscore its strategic focus on the tumor microenvironment (TME). The company wanted to concentrate more closely on developing drugs that influence tumors’ protective mechanisms and thereby support existing cancer therapies. NOX-A12 became its most important clinical program.

Yet even under its new name, the company failed to secure lasting financing for the next stage of development. This became particularly apparent in the planned further expansion of the GLORIA study. The Phase 1/2 study had investigated NOX-A12 in combination with radiotherapy and bevacizumab in newly diagnosed glioblastoma. The company considered the results to date promising. But it lacked the money for a larger randomized Phase 2 study.

Mangasarian repeatedly sought to attract strategic partners and institutional investors for the next development phase. In a 2024 CEO statement, he referred to discussions with potential partners, non-dilutive grants and institutional investors. His personal participation in capital raises was also intended to signal confidence. The breakthrough never came.

Bitcoin pivot: In June 2025, Diede van den Ouden took over the leadership of TME Pharma. Mangasarian stepped down as CEO but was to remain connected to the company as an adviser on scientific and strategic matters. Van den Ouden was introduced as a manager with experience in financial restructuring and turnaround situations. He was already a shareholder and had participated in a financing round.

The new strategy initially called for a drastic streamlining of the organization. A largely outsourced staffing model was intended to reduce running costs and enable the company to continue pursuing its two remaining drug programs, NOX-A12 and NOX-E36. At the same time, management wanted to explore alternative financing routes.

Then, in the summer of 2025, an unusual announcement attracted attention: TME Pharma changed its treasury policy to allow some of its available funds to be invested in higher-risk assets such as cryptocurrencies. Van den Ouden pointed to his investment experience and investor interest in cryptocurrency holding companies. In time, a successful investment business could even extend beyond conventional treasury management and become part of the company’s strategy.

This was a remarkable change of direction for a company whose actual purpose was supposed to be developing new medicines. At least, TME Pharma announced in January 2026 that it had not yet made any cryptocurrency investments because no attractive opportunity had arisen. Instead, its cash balance stood at around €2 million at the end of 2025. Other considerations involving equity investments and possible business activities outside drug development were also intended to broaden its financial base.

Meanwhile, its core biotech business remained largely on standby. The glioblastoma clinical study was kept open so it could resume if suitable financing or a partnership became available. Finding such a partner thus became the crucial prerequisite for NOX-A12’s future.

TMS to the rescue: With TMS, a possible way forward now appears to have been found. The Japanese company is itself active in clinical-stage biotechnology and intends to establish a subsidiary through which financing and further development of NOX-A12 would be organized. TME Pharma would remain involved as a partner and minority shareholder but would no longer have to bear sole responsibility for financing the entire program.

The model could benefit both sides: TMS gains access to a clinical-stage drug with existing data and special regulatory designations, while TME Pharma gets the opportunity to continue development without having to undertake a major capital raise itself. The new company would raise the funds for further development and advance the program.

NOX-A12 has already completed a Phase 1/2 study called GLORIA. It investigated the combination with radiotherapy and bevacizumab in patients with newly diagnosed glioblastoma and an unmethylated MGMT promoter, who are unlikely to benefit from standard chemotherapy. The results were published in Nature Communications in April 2026. According to the company, statistically significant survival benefits were observed in the patient groups studied. The US Food and Drug Administration has granted the drug fast-track and orphan-drug designations for glioblastoma. It also holds orphan-drug designation for glioma in Europe.

The planned Phase 2 study is now intended to test these clinical signals in a larger, more controlled setting. Only then will it become clear whether NOX-A12 truly has the potential to establish itself as a new treatment option for glioblastoma. The results of the GLORIA study so far are encouraging, but they are certainly no substitute for evidence from a randomized trial.

The big picture: For TME Pharma, the agreement with TMS is more than an ordinary licensing partnership. It could mark the end of a multi-year search for a viable business model. Instead of keeping itself afloat through cryptocurrency investments, equity holdings and other financial activities, the company could once again focus on developing its original drug candidates.

It has not reached that point yet, however. The €150,000 exclusivity payment is a modest sum to begin with. The actual development financing still has to be secured through the new subsidiary. Nor is the approximately €10 million that TME Pharma would receive upon signing the definitive agreement assured. The more than €100 million in milestone payments, meanwhile, depend on regulatory and commercial successes that could still be years away.

Also notable: The second major program, NOX-E36, also remains outside the agreement for now. The CCL2 inhibitor is being investigated for ophthalmic diseases with high unmet medical need. TME Pharma continues to seek partners that could take over or finance its further development.

The new agreement therefore offers a glimmer of hope for a company that had, for a time, strayed far from its original business model. Whether TME Pharma actually becomes a biotech company with a clinical development path again will depend not on the announcement of a collaboration, but on whether TMS secures the financing and the GLORIA study actually resumes.

The return to a drug development business model has begun, but the route back to the clinic is not yet funded.

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