Diede van den Ouden, an experienced CEO with successful background in small-cap turnarounds, to be nominated for appointment as CEO at upcoming AGM in June 2025
Operational costs to be strongly reduced through outsourced staffing model as from July 1, 2025 while maintaining the ability to advance both NOX-A12 and NOX-E36 assets
Streamlined Supervisory Board with two members stepping down at upcoming AGM
Management confident in securing non-dilutive financing to cover short-term operational needs
Support for the new strategy and CEO nomination from existing shareholders with significant shareholdings
BERLIN, May 05, 2025--(BUSINESS WIRE)--Regulatory News:
TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces today a strategic change to facilitate ongoing efforts to finance the next clinical trial for NOX-A12 through agreements with pharma or financial partners.
The strategy will involve the nomination of Diede van den Ouden as the new CEO of TME Pharma N.V. at the upcoming annual general meeting of shareholders (AGM) in June 2025. Diede van den Ouden will bring to TME Pharma his experience in managing and advising listed companies and taking companies through financial reorganization, in particular with Tonner Drones and Lavide Holding. Van de Ouden is currently a TME Pharma shareholder. Aram Mangasarian will step down as CEO following appointment of Diede Van de Ouden, but will continue to advise the company on a consulting basis on scientific and strategic matters.
The strategy also includes further cost-cutting measures, first announced in December 2024, to transform into a leaner organization functioning primarily on a lower-cost outsourced staffing model. This model will be fully implemented starting July 1, 2025, significantly reducing ongoing expenses and thereby decreasing the company’s financing needs.
TME Pharma will continue to pursue all ongoing discussions and opportunities to optimize the value of its NOX-A12 and NOX-E36 assets. Both assets will be maintained to allow rapid advancement of the programs once financing and/or partnerships are in place. As announced in March, the goal for NOX‑E36 is the creation of a new corporate entity with our collaboration partner, the Singapore Eye Research Institute, with full rights to develop NOX-E36 further in ophthalmology, supported by private investors.
"Although I decided to step down as CEO with Diede’s appointment at the upcoming AGM, I still believe strongly in the quality and potential of TME Pharma’s products. I will work closely with Diede to ensure that Diede is brought up to speed on all needed operational and financial details of TME Pharma. I will remain a shareholder and will be available to assist Diede in coordinating and supporting TME Pharma R&D activities," said Aram Mangasarian, CEO of TME Pharma. "In the current context I believe that a CEO with a finance background like Diede is the best path forward to optimize the company’s financial situation and unlock new opportunities to create value for TME Pharma shareholders."
"I am excited to join TME Pharma," said Diede van den Ouden. "I am a shareholder and have been following the company for years. I am convinced that TME Pharma owns great assets, and with the right strategy for the current situation and the right timing, we will make sure this value becomes available to shareholders.I have suggested to the company that a nondilutive financing would be a good solution near-term, and something I would be willing to participate in personally."
Two members of the Supervisory Board, Oscar Izeboud and Sandra Glucksmann, will step down at the AGM in June to adapt the size of the board to the current needs of the company. This step will also reduce ongoing costs and it should be noted that the current chairman, Maurizio PetitBon, has waived cash compensation during his current appointment.
A group of larger shareholders in TME Pharma has been consulted about the transition to van den Ouden as CEO and is supportive of his candidacy and the overall strategy for TME Pharma.
The convocation of the 2025 annual general meeting of shareholders will be published later this month.
About TME Pharma
TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is 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. By neutralizing chemokines in the TME, TMEPharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA Phase 1/2 clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer) in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. US FDA has 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. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in the United States. The company’s second clinical-stage drug candidate, NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), showing potential to address fibrosis and inflammation is evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. Further information can be found at: www.tmepharma.com.
TME Pharma® and the TME Pharma logo are registered trademarks.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
GLORIA (NCT04121455) is TMEPharma’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). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab.
About the OPTIMUS Study
OPTIMUS (NCT04901741) is TMEPharma’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 TMEPharma’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.
