resulted in the issuance of 1,940 new shares for gross proceeds of EUR0.4
thousand. Outstanding 2,811,080 Warrants Z have potential to raise an
additional EUR0.7 million if exercised in full before the end of the
final exercise period in June 2025.
TME Pharma has focused its financial resources on achieving its primary goal of generating mature overall survival data in the GLORIA trial of NOX-A12 in brain cancer and creating an attractive clinical and regulatory package to enable initiation of Phase 2 trial. 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.
Considering cash and cash equivalents of EUR2.7 million as of June 30, 2024, TME Pharma has financial visibility into January 2025.
Outlook for the Remainder of 2024 and for 2025
NOX-A12 Clinical Development Plans in Glioblastoma
TME Pharma has achieved significant regulatory milestones in advancing the NOX-A12 glioblastoma program to the next phase of clinical development, having received approval for the Phase 2 study protocol from both the FDA in the US and BfArM in Germany. TME Pharma's next milestones in the clinical development of the NOX-A12 program are financing and initiation of the randomized, controlled Phase 2 clinical trial. With clinical trial preparations underway and sufficient supply of NOX--A12 available, the clinical trial can be launched rapidly upon closing of the funding gap. The company is actively engaged in discussions with potential strategic industrial partners and governmental institutions to out-license NOX-A12 and secure non-dilutive support for the upcoming clinical trial.
NCI's Presentation of NOX-A12 Pre-Clinical Research at SNO
The Society for Neuro-Oncology (SNO) Annual Meeting in November 2024 will feature a poster presentation highlighting data from preclinical studies conducted at the U.S. National Cancer Institute $(NCI)$ exploring the effects of inhibition of CXCL12 by NOX-A12 in combination with immune checkpoint inhibition in glioblastoma models. The research was conducted at the NCI under the material transfer agreement established with TME Pharma in June 2022 to explore the effects of TME Pharma's CXCL12 inhibitor NOX-A12 in brain tumors.
Clinical development plans for NOX-E36
While TME Pharma has largely focused its available resources on NOX-A12 during recent years, TME Pharma also has a second clinical-stage asset, NOX-E36. While limited resources have been employed behind NOX-E36 over the last two years, it presents a very promising opportunity for development in eye diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The anti-fibrotic mode of action of NOX-E36 has already been demonstrated in a relevant animal model published by researchers at the Singapore Eye Research Institute (SERI), and TME Pharma believes that development in ophthalmological indications could be a promising opportunity to diversify its project portfolio. For these reasons, TME Pharma has engaged in discussions with multiple players and institutions specialized in ophthalmology to develop NOX-E36 in the clinic with minimal or no financial contribution from TME Pharma, yet leaving a potential commercial success as potential upside to TME Pharma's investors.
The Group will carefully monitor its available cash and calibrate additional financings through available sources in order to ensure its ability to complete its ongoing trial and pursue financing of its future clinical development plans in brain cancer and, to the extent deemed appropriate, maintain a sufficient cash runway, yet minimize shareholder dilution whenever possible.
The Half-Year Financial Report 2024 can be downloaded from the TME Pharma website.
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 Phase 1/2 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. 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$(R)$ 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(R) 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. Further information can be found at: www.tmepharma.com.
TME Pharma(R) and the TME Pharma logo are registered trademarks.
Keytruda(R) is a registered trademark of Merck Sharp & Dohme Corp.
Visit TME Pharma on LinkedIn and X.
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 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241018066363/en/
CONTACT: TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 16637082 0
investors@tmepharma.com
Investor and Media Relations:
LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com
NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr
(END) Dow Jones Newswires
October 18, 2024 12:00 ET (16:00 GMT)
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