BERLIN, February 17, 2025--(BUSINESS WIRE)--Regulatory News:
TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for the treatment of cancer by targeting the tumor microenvironment (TME), released today a message from Aram Mangasarian, CEO of TME Pharma, to its shareholders.
Dear Shareholders,
As we enter 2025, TME Pharma is emboldened by the clinical and regulatory successes of the previous year and by promising advancements on other fronts. Our new strategic roadmap, announced in December 20241, is designed to unlock value from our drug candidates and technology platform to the benefit of both our shareholders and the patients we aim to help. In the coming months, we will focus on executing several key initiatives that are central to our plan.
Key Initiatives and Milestones for 2025
Strategic Partnerships and Transactions: We are engaged in active and constructive discussions with potential strategic industrial partners and investors regarding possible transactions which we believe could deliver meaningful value for our shareholders within our current cash runway. Being encouraged by these discussions, we are in the process of identifying the most appropriate advisory firm to support us in such transactions.
NOX-A12 Clinical Development: Our preparations for the randomized, controlled Phase 2 evaluation of NOX-A12 in glioblastoma are advancing well. Having a strong preclinical, clinical and regulatory package and a clear development pathway for NOX-A12, we have received interest from over 30 notable clinicians in the US, the UK and Germany to participate in the next trial. With the available supply of NOX-A12 we can launch the trial rapidly once a pharmaceutical partner is identified or the remaining funding is secured. We have secured significant non-dilutive funding for the trial, including a German Federal grant of €2.4 million, bringing the total support to over €7 million2.
AI-Driven Drug Discovery: Our recently announced partnership with aimed analytics enhances our capabilities to leverage AI in drug discovery and optimization. The goal of this collaboration is to allow TME Pharma to not only bring its existing drugs to the table for strategic partners, but also the potential for rapid and efficient discovery of new drugs3.
Financial Position and Strategy: The successful €2.6 million public offer completed in December 2024 has extended our financial visibility into June 20254. During 2024, we removed all convertible debt instruments from our balance sheet5 and raised more than €7.5 million through multiple financial transactions. We are committed to maintaining a lean cost structure while focusing on strategic transactions and clinical advancements. As described in our December 2024 strategic roadmap, we are also preparing to further reduce cash need in mid‑2025, if necessary, while maintaining the readiness of our programs for completion of strategic transactions on both NOX-A12 and NOX-E36.
Strategic Vision and Outlook
Our vision for our lead asset NOX-A12 remains clear: to secure approval for its use in glioblastoma patients through a strategic partnership with a pharmaceutical company, supported by governmental and charitable organizations and expert biotech investors. While glioblastoma remains a challenging indication with high unmet medical need, the significant and encouraging survival data generated with NOX-A12 show the potential to provide a more effective therapy for this devastating disease. We believe that the need for pharma companies to replenish their medium-term product pipelines with innovative assets makes NOX-A12 an attractive opportunity for potential partners looking to enhance their portfolios with impactful therapies.
While we plan to maintain our focus on oncology, we have identified a promising opportunity for the rapid advancement of NOX-E36 in the ophthalmology space. Having sufficient drug supply for initial preclinical and clinical studies, we have been working with ophthalmology experts to lay the framework to generate proof-of-concept clinical data at limited cost to TME Pharma. Our goal is to create a new entity with full rights to develop NOX-E36 further in ophthalmologic indications, supported by private investors.
I would like to offer my sincerest appreciation to all our shareholders for your continued confidence and your support of our company and our mission. Your strong participation in our recent public offer clearly demonstrates your belief in our strategic direction. I look forward to updating you on our progress in the coming months.
Yours sincerely,
Aram Mangasarian CEO, TME Pharma February 17, 2025
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.
_____________________________________ 1TME Pharma Press Release of December 04, 2024 2TME Pharma Press Release of October 31, 2024 3TME Pharma Press Release of January 29, 2025 4TME Pharma Press Release of December 23, 2024 5TME Pharma Press Release of February 29, 2024
