TME Pharma reports H1 2023 financial results and provides business update

• Survival data from NOX-A12 GLORIA Phase 1/2 trial in brain cancer continue to improve and have already surpassed all relevant competitors  
   
• 67% overall survival at 18 months for NOX-A12 combination regimen with VEGF inhibitor and radiotherapy vs. 5% for standard of care

TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces its financial results and business highlights for the six months ending June 30, 2023, and provides an outlook for the rest of the year.

Aram Mangasarian, CEO of TME Pharma commented: "This year has been a highly productive period for TME Pharma in which we have reported unprecedented survival rates for newly diagnosed brain cancer patients with chemotherapy resistant tumors not amenable to complete surgical removal receiving our lead asset NOX-A12 in combination with radiotherapy and VEGF inhibition. These maturing survival data not only position NOX-A12 as potentially the best available treatment for glioblastoma, but they also mean we have advanced to the point where we can now engage with the FDA on the next clinical and regulatory development steps for NOX-A12. These include an Investigational New Drug filing and potential access to expedited regulatory pathways, which we expect to achieve in early 2024.  We are convinced that this will generate significant interest among investors and potential partners. This year has also seen TME Pharma take a major step forward in our commitment to our shareholders to end the use of convertible bond financing with the successful completion of a €2 million financing that included a lock-up of new shares and bond conversions for a period of six months. This innovative transaction secured new cash and investors while allowing us to remain focused on our goal of developing novel therapies for cancer and bringing them to market. We are solidly financed into 2024 and looking forward to achieving further clinical and regulatory progress in the months ahead.”

About the GLORIA Study

GLORIA (NCT04121455) 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). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.

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.