TME Pharma provides update on its activities
TME Pharma provides update on its activities
- TME Pharma enters the final evaluation phase of advanced discussions with two potential partners for a license agreement.
- Discussions and potential partnership are aimed at enabling the further development of the phase2-development of flagship product NOX-A12.
- NOX-A12 holds FDA and EU Orphan Drug and FDA Fast Track designations in glioblastoma, supported by recent peer-reviewed publication in Nature Communications.
- With estimated yearly peak sales potential (upon successful market approval and commercialization) of approximately $1 billion, NOX-A12 is a highly valuable flagship drug for treating brain cancer for which there is currently no known cure.
- TME Pharma has decided to focus its strategy for its second clinical asset strategy for NOX-E36 also on a licensing deal. Discussions regarding this are at a less advanced stage than those for NOX-A12.
- TME Pharma decided not to continue with the GRDC-project, but continues its efforts to bring alternative and additional business to the listed holding entity.
- TME Pharma reports a share transaction by the CEO, notified to the AFM in accordance with Article 19 MAR.
Berlin, Germany, August 24, 2026, 8.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for brain cancer and eye diseases, today provides an update on its activities, including the strategic development options for its lead oncology asset, NOX-A12.
Following comprehensive discussions and due diligence over recent months, TME Pharma has advanced conversations with two potential partners. The company is now approaching the decision-making stage to select the optimal partner and best path forward for the late-stage development and commercialization of NOX-A12.
Strategic Decision Framework & Value Creation
The evaluation of these final strategic options extends beyond transactional valuation and financial terms. TME Pharma is strictly focused on structuring the continuation of the landmark GLORIA trial in a manner that creates the highest long-term value. Key strategic parameters currently under final review include:
- Trial Architecture & Regulatory Pathways: Maximization of the likelihood and confidence that the next step of clinical development will be funded and conducted by selecting a committed partner who is aligned with TME Pharma in the goal to perform the upcoming GLORIA study in a way that creates optimal additional value.
- Commercial potential: Structuring the research framework to ensure that NOX-A12 reaches its full peak revenue potential within the most favorable timeframe to maximize patent-protected revenues.
- Financial conditions: TME Pharma NV and its shareholders need to have a clear picture of a solid short-term future so that there is clarity regarding cash flow. Future potential value must be secured if the drug can be successfully brought to market.
Robust Scientific Validation and Significant Peak Sales Potential for NOX-A12
The strong clinical foundation of NOX-A12 in glioblastoma—an aggressive form of brain cancer with limited treatment options—is supported by compelling data from the GLORIA trial. The efficacy of the NOX-A12 "Triple Therapy" combination (NOX-A12, radiotherapy, and anti-VEGF / bevacizumab) was recently highlighted in a high-impact peer-reviewed publication in Nature Communications, demonstrating significantly improved overall survival (19,9 months against 9,5 months) compared to standard-of-care benchmark cohorts.
Building on these findings, TME Pharma has a randomized, controlled Phase 2 trial protocol ready-to-go in Germany and approved in the US, secured Fast Track Designation from the U.S. FDA and Orphan Drug Designation (granted by both the U.S. FDA and the European Medicines Agency, EMA) for NOX-A12 in glioblastoma. The Total Addressable Market for Glioblastoma is estimated at 2.5 billion. With estimated peak sales potential (upon successful market approval and commercialization) expected of approximately $1 billion, NOX-A12 represents a highly valuable flagship asset capable of transforming care in treatment-resistant solid tumors.
Capitalizing on Favorable Biotech Market Dynamics
TME Pharma has observed a clear improvement in market sentiment, characterized by increased demand from the sector for the acquisition and joint development of promising clinical-stage drugs. In addition, the stock markets are showing a positive trend, with renewed capital inflows into biotech companies.
TME Pharma is well-positioned to capitalize on these favorable market conditions, supported by a strong asset portfolio and positive outlook. Furthermore, as announced on March 9, 2026, the company’s financial flexibility has been extended into the second quarter of 2027, providing the flexibility to find the optimal partner for NOX-A12.
"Our discussions in the last months have yielded concrete strategic interest from two parties. As we enter the final evaluation phase, our priority is to select the partner and structuring strategy that maximizes both the commercial value of NOX-A12 and its clinical benefit for patients. We look forward to updating the market as soon as a decision has been made." Said Diede van den Ouden, CEO of TME Pharma NV
NOX-E36
The study announced in January has now been completed, and its objective to establish and validate a detection method for toxicology studies to support clinical ophthalmology development has been successfully achieved.
In addition, TME Pharma continues to explore partnering opportunities for NOX-E36 and will update the market if and when there is a concrete development to report.
GRDC and alternative activities
On November 5th 2025, TME Pharma announced that it had signed a LOI with a German Resource Development Company (‘GRDC’). TME Pharma has decided not to continue its collaboration with GRDC.
As a publicly traded holding company, TME Pharma also intends to develop alternative business activities in addition to entering into licensing agreements for its lead biotech assets. The objective is to create additional value for shareholders and to generate cash flow from the Company’s own operations.
TME Pharma will therefore continue its search for sound and future-proof companies and activities. It will inform the market when interesting opportunities arise and seek shareholder approval before making a final decision.
Share transaction by the CEO
TME Pharma today announces that it has received notification that Diede van den Ouden, Chief Executive Officer and a Person Discharging Managerial Responsibilities (“PDMR”), has sold 460,050 ordinary shares on Euronext Growth Paris on August 19, 2026 at an average price of EUR 0,1107 per share, pursuant to an irrevocable sell instruction with pre-set price limits and a volume cap, placed with his broker on May 20, 2026 and recorded by the broker’s compliance department. Following this transaction, Mr. Van den Ouden interests remain aligned with those of shareholders. Mr. van den Ouden holds 2,214,950 ordinary shares, approximately 6.8 million warrants (provided as part of two loan agreements by Mr. van den Ouden for a total amount of € 520,956 entered into in May 2025 and and August 2025) and 3.2 million options in the Company. The transaction has been notified to the AFM in accordance with Article 19 of the Market Abuse Regulation, and the overview of the CEO’s transactions in the Documentation section of the Company’s website has been updated accordingly. The orders were solely intended to diversify the risks across the entire portfolio. Currently, the broker still has 3 irrevocable sell instructions from Mr. van den Ouden outstanding: 214,950 ordinary shares with a pre-set minimum price limit of €0.11, and two irrevocable sell instructions of 1.0 million ordinary shares each with pre-set minimum price limits of €0.14 and €0.17, respectively, capped at a maximum of 15% of the daily trading volume, and valid until the end op 2026.
For more information, please contact:
TME Pharma N.V.
Diede van den Ouden, CEO
ir@tmepharma.com
www.tmepharma.com
About TME Pharma
TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair.
TME Pharma has currently 2 main assets for development:
- NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe.
- NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect.
The Company is currently seeking opportunities to secure the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include:
- Raising funds from alternative sources
- Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company
- Leveraging tax loss carry forwards
Further information can be found at: www.tmepharma.com.
About the GLORIA Study
The GLORIA (NCT04121455) ‘ready to go’-study is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).
About the OPTIMUS Study
OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.
Disclaimer
Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.
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