TME Pharma Publishes Unaudited Financial Results for Fiscal Year 2022

2022 Financial Summary

TME Pharma successfully strengthened its balance sheet by raising €7.3 million net cash under the Atlas Special Opportunities (ASO) facility in 2022. Considering cash and cash equivalents of €4.6 million as of December 31, 2022, TME Pharma has financial visibility into September 2023.

As in prior years, TME Pharma has not generated any revenues. The Group – TME Pharma N.V., TME Pharma AG and TME Pharma Inc. – does not expect to generate any revenues from any product candidates that it develops until the Group either signs a licensing agreement or obtains regulatory approval and commercializes its products or enters into collaborative agreements with third parties.

Research and development (R&D) expenses accounted for 68% of total operating costs. The R&D expenses decreased from K€ 10,657 in 2021 to K€ 8,148 in 2022 due to lower costs associated with clinical trials, including costs for drug manufacturing, service fees and other costs related to clinical trials and preclinical testing, partly offset by increased patent costs and consulting services, personnel expenses and other expenses. The R&D expenses were primarily related to the ongoing GLORIA trial of NOX-A12 in brain cancer.

General and administrative (G&A) expenses increased from K€ 2,876 in the Fiscal Year 2021 (FY 2021) to K€ 3,882 in FY 2022 to support operational activities. The increase in G&A expenses in 2022 was mainly driven by higher personnel expenses as well as higher legal, consulting and audit fees. In addition, public and investor relations expenses and other expenses increased compared to 2021. In 2022, TME Pharma executed on several corporate actions concerning the reorganization of share capital and the company name change, also resulting in an increase in G&A expenses. The increase in personnel expenses was also driven by the addition of the CFO, who departed end of 2022.

The finance income in the FY 2022 and 2021 was entirely non-cash finance income. Finance income decreased from K€ 319 in the FY 2021 to K€ 303 in the FY 2022 and resulted predominantly from the derecognition of ASO conversion rights.

Finance cost amounted to K€ 3,400 in the FY 2022 (compared to K€ 1,504 in the FY 2021) and was noncash expense, except for transaction costsresulting from issuance of convertible bonds (K€ 122 in 2022 and K€ 47 in 2021). Non-cash finance cost mainly reflected losses on initial recognition of ASO convertible bonds, conversion losses and conversion right derivatives.

As a result of these factors, TME Pharma N.V. reports a net loss for FY 2022 of K€ 15,133 compared to K€ 14,453 in the FY 2021. In 2022, the net loss from operations is K€ 12,029 and decreased compared to prior year by 9%. Net cash used in operating activities amounted to K€ 12,143 in FY 2022 compared to K€ 12,381 in FY 2021.

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/nabpaclitaxel 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 "forwardlooking 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.