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
1 TME 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