Germany - 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 EUR2 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.
H1 2023 Financial Highlights
For the reporting period, the Group - TME Pharma N.V., TME Pharma AG and TME Pharma Inc. - has not generated any revenues. The Group, like most pre-commercial biotech companies, does not expect any revenues to be generated from any product candidates that it develops until the Group either signs a licensing or collaboration agreement or obtains regulatory approval and commercializes its compounds.
Research and development (R&D) expenses decreased by 77% in H1 2023 over the same period last year. This significant reduction is primarily due to the GLORIA trial of NOX-A12 in brain cancer nearing completion, which required lower costs while at the same time generating more mature data. The process to bring the OPTIMUS pancreatic cancer trial Phase 2 protocol to FDA approval in the US was also successfully completed in Q2 2023, reducing ongoing costs related to this trial. As a result, TME Pharma was able to decrease drug manufacturing costs, service fees and other costs related to the clinical trials and preclinical testing, in addition to lower personnel expenses, patent costs and consulting services.
General and administrative (G&A) expenses decreased by 27% in H1 2023, mainly driven by lower personnel expenses and lower legal, consulting and audit fees. The net loss from operations for H1 2023 was EUR2.8 million, a 64% decrease on the prior year period. TME Pharma has focused its financial resources on achieving its primary near-term goal of generating mature overall survival data in the GLORIA trial of NOX-A12 in brain cancer. With the trial now nearing completion, TME Pharma will assess how and where to deploy the Group's available financial resources to maximize the chances of NOX-A12 reaching the market.
In April 2023, the company raised EUR2 million as part of an innovatively structured transaction that involved EUR1.00 million in equity financing (gross) from a group of new investors and a EUR1.08 million convertible bond financing (nominal) under the agreement with Atlas Special Opportunities, LLC (ASO). ASO also converted EUR2 million convertible bonds into shares as part of the transaction at the same price per share as the new investors, thus aligning the financial interests of all investors participating in the transaction. In addition, TME Pharma has committed not to draw any further tranches from the ASO convertible bond vehicle and the agreement with ASO was terminated other than with regards to the convertible bonds held by ASO following the transaction. This transaction thus marked the company's commitment to end reliance on convertible bond financing. By removing the pressure of convertible bonds and introducing the six-month soft lock-up of shares, the company's objective was to strengthen its position and valuation in the financial market. Considering cash and cash equivalents of EUR3 million as of June 30, 2023, TME Pharma has financial visibility into February 2024. Management is engaged in active discussions and anticipates the ability in the coming weeks to extend financial visibility beyond the planned regulatory value inflection points in 2024.
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, TME Pharma's approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 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. NOX-A12 in combination with radiotherapy has received orphan drug designation 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 France, Spain and the United States. The company's second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development.
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.
Contact:
Aram Mangasarian
Tel: +49 (0) 30 726247 0
Email: investors@tmepharma.com
TME PHARMA N.V. 