New Risk • May 18
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€570k). Revenue is less than US$1m (€27k revenue, or US$31k). Market cap is less than US$10m (€7.43m market cap, or US$8.64m). Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Share price has been volatile over the past 3 months (8.5% average weekly change). Ankündigung • Apr 18
TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature Communications TME Pharma N.V. announced a Nature Communications article on the results from the Phase 1/2 expansion Arm A cohort of the GLORIA trial testing NOX-A12 + radiotherapy + anti-VEGF triple therapy in glioblastoma patients. The article in the scientific peer-reviewed high-impact journal, Nature Communications, describes results of the expansion cohort Arm A in TME Pharma’s Phase 1/2 GLORIA trial. In this arm, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients with residual tumor after surgery received NOX-A12 + radiotherapy + anti-VEGF (bevacizumab) Triple Therapy. The authors noted that overall survival (OS) of patients receiving NOX-A12 Triple Therapy significantly outperformed two different cohorts of similar patients external to the trial who received standard of care treatment, and further noted that due to the conservative trial design, the study likely underestimates survival compared with most contemporary trials. As already disclosed in the March 5, 2024 press release, the GLORIA trial has been amended to allow inclusion of 100 additional patients in a randomized, controlled Phase 2 part of the trial composed of 5 additional arms (Expansion Group Arms D through H) to assess three different doses of NOX-A12 in the Triple Therapy, one dose of NOX-A12 + radiotherapy and standard of care. It is planned to initiate this Phase 2 part of the trial once appropriate partnerships are in place. The findings described in the publication demonstrate the potential and value of TME Pharma’s NOX-A12 asset. New Risk • Dec 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€570k). Shareholders have been substantially diluted in the past year (123% increase in shares outstanding). Revenue is less than US$1m (€27k revenue, or US$32k). Market cap is less than US$10m (€5.32m market cap, or US$6.23m). New Risk • Nov 04
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€570k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€570k). Shareholders have been substantially diluted in the past year (123% increase in shares outstanding). Revenue is less than US$1m (€60k revenue, or US$69k). Market cap is less than US$10m (€8.58m market cap, or US$9.86m). Minor Risk Share price has been volatile over the past 3 months (6.7% average weekly change). Ankündigung • Sep 22
TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025 TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025 New Risk • Jul 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings have declined by 1.7% per year over the past 5 years. Shareholders have been substantially diluted in the past year (123% increase in shares outstanding). Revenue is less than US$1m (€19k revenue, or US$22k). Minor Risk Market cap is less than US$100m (€9.86m market cap, or US$11.6m). Ankündigung • Jun 25
Tme Pharma N.V. Appoints Diede Mink Van Den Ouden as Sole Member of the Board of Directors TME Pharma N.V. announced the unanimous approval of all resolutions submitted to its 2025 annual general meeting of shareholders (AGM), including the appointment of Diede Mink van den Ouden as sole member of the board of directors. Ankündigung • Dec 05
TME Pharma N.V. has filed a Follow-on Equity Offering in the amount of €2.6 million. TME Pharma N.V. has filed a Follow-on Equity Offering in the amount of €2.6 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 52,000,000
Price\Range: €0.05
Transaction Features: Rights Offering Ankündigung • Nov 01
TME Pharma Receives €2.4 Million German Federal Ministry of Education and Research Grant to Support NOX-A12 Phase 2 Trial in Brain Cancer TME Pharma N.V. announced that it is awarded a non-refundable grant of EUR2.4 million from the KMU-innovativ funding program run by the German Federal Ministry of Education and Research. The non-dilutive non-refundable funding will support TME Pharma's planned Phase 2 randomized controlled study evaluating its lead asset, the CXCL12 inhibitor NOX-A12, for use in the treatment of aggressive adult brain cancer, glioblastoma. In the Phase 2 study design, approved by the US Food and Drug Administration and the German regulator, glioblastoma patients will be treated in five different arms that will address questions of dosing and assess the contribution of the NOX-A12 and bevacizumab components to the overall efficacy of the combination therapy. TME Pharmawill be able to optimize late phase development by selecting the best performing treatment arm against standard of care. The Phase 2 results will serve as a basis for discussions with regulatory authorities on the design of the further development strategy, up to market approval, and for discussions with potential partners, such as pharmaceutical companies. Ankündigung • Oct 18
TME Pharma N.V. Provides Clinical Update TME Pharma N.V. provided clinical update. The GLORIA NOX-A12 clinical trial has achieved exceptional clinical results in newly diagnosed glioblastoma patients with extremely poor prognosis that have tumors resistant to standard chemotherapy plus incomplete surgical resection showing potential benefit as a therapy for glioblastoma. The study achieved a remarkable 19.9-month median overall survival (mOS) rate for patients receiving NOX-A12 in combination with the VEGF inhibitor bevacizumab and radiotherapy. This doubles the 9.5-month mOS rate demonstrated in the standard of care matched reference cohort, as presented by Dr. Frank Giordano, the lead investigator of the clinical trial, at the European Society for Medical Oncology (ESMO) conference in September 2024. The ESMO presentation further revealed statistically significant improvement in survival for this triple combination (NOX-A12 + bevacizumab + radiotherapy) over standard of care reference cohort as well as NOX-A12 + radiotherapy alone. Analysis of the competitive landscape has shown that the NOX-A12 survival results surpass those from what TME Pharma believes are all relevant therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. NOX A12’s effectiveness is even more impressive considering the NOX-A12 GLORIA trial enrolled patients with a worse prognosis than those in the competitor trials. The NOX-A12 trial only enrolled patients with residual detectable tumor after surgery whereas competitor trials also included patients with no detectable tumor after surgery, i.e. patients that would be expected to have a better average survival outcome. This progress highlights the immense potential of NOX-A12 to transform the treatment of glioblastoma patients, who face a devastating prognosis from this highly aggressive form of brain cancer. Clear Path for Phase 2 Clinical Development with Open IND and Fast Track Designation Awarded by US FDA, and Protocol Approved in Germany . TME Pharma engaged in discussions with the US Food and Drug Administration (FDA) in late 2023 to establish a clear regulatory roadmap for the next stage of NOX-A12's clinical development. The FDA cleared in March 2024TME Pharma’s Investigational New Drug (IND) application on the basis of the protocol for a randomized, controlled Phase 2 clinical trial in glioblastoma, allowing the company to expand clinical development in the US. Subsequently, the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) has also approved the protocol, enabling the company to conduct Phase 2 study in Germany. NOX-A12 was also granted Fast Track designation by the US FDA. This designation aims to facilitate the development and expedite the review of drugs addressing serious conditions like glioblastoma. Companies whose programs are granted Fast Track Designation can benefit from more frequent interactions with the FDA during the clinical development process, and thus potentially accelerated timelines. TME Pharma perceives the achievement of these two key regulatory milestones as the FDA's recognition not only of the urgent unmet medical need which glioblastoma represents, but also the potential of NOX-A12 to address it. This paves the way to accelerate NOX-A12's route to market while providing investors and potential partners with a clear development pathway for NOX-A12. Ankündigung • Oct 01
TME Pharma N.V. Announces Appointment of Alexandra Glucksmann to Supervisory Board TME Pharma N.V. announced that the nomination of Dr. Alexandra Glucksmann to the Supervisory Board was approved at the extraordinary general meeting of shareholders (EGM), which took place on September 30, 2024. Ankündigung • Jun 28
TME Pharma N.V. Appoints Lee Schalop as Member of the Supervisory Board TME Pharma N.V. announced that at its AGM held on June 27, 2024 the appointment of Lee Schalop as member of the supervisory board. New Risk • Apr 28
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€294k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-€294k). Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (436% increase in shares outstanding). Revenue is less than US$1m (€17k revenue, or US$18k). Market cap is less than US$10m (€7.08m market cap, or US$7.58m). Ankündigung • Apr 23
TME Pharma N.V. Announces 33% of Patients Receiving NOX-A12 in Combination With Bevacizumab and Radiotherapy Achieve Two-Year Survival in GLORIA Phase 1/2 Trial in Brain Cancer TME Pharma N.V. announced a positive update on survival at two years for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy. Two out of the six glioblastoma patients in this expansion arm of the GLORIA Phase 1/2 trial have survived for more than 24 months since the start of therapy. These two patibents had tumors which, at one point during treatment, either disappeared completely or reached near-complete reduction (>99%) in size. The first patient to cross the two-year survival milestone had maintained a physical and cognitive condition within the norm, displaying only minimal disease-specific symptoms at this timepoint. This translates to a preserved quality of life, as evidenced by the patient’s continued ability to engage in hobbies, leisure activities, and social interaction. The second patient’s clinical status at the last assessment at 23 months was stable, although certain neurological functions had been partially affected. This patient’s course is also remarkable in that they received no therapy expected to prolong survival in the last 18 months since they decided to end treatment with the NOX-A12 combination following a near-complete reduction of tumor as assessed by MRI. In February, TME Pharma announced the final median overall survival (mOS) for this NOX-A12 cohort had reached an unprecedented 19.9 months. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approximately 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. TME Pharma recently announced two key regulatory milestones with the clearance by the U.S Food and Drug Administration (FDA) in March of the company's Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharmato proceed with the continued clinical development of NOX-A12 in a new Phase 2 study. This was followed by the FDA's award of Fast Track designation to NOX-A12 in glioblastoma in April. Fast Track designation aims to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs, and could support an accelerated pathway to U.S regulatory approval. Preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharma is aiming to initiate the new study as soon as the necessary resources from financial and industrial partners have been secured. Ankündigung • Apr 03
TME Pharma N.V. Receives US FDA Fast Track Designation for Lead Asset NOX-A12 in Brain Cancer TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol), TME Pharma'sCXCL12 inhibitor, in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma, in the newly diagnosed setting where the tumor is resistant to chemotherapy and measurable tumor remains after surgery. The FDA's Fast Track designation aims to bring important new drugs to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation can benefit from more frequent interactions with the FDA during the clinical development process and potentially "accelerated approval" and "priority review" if the relevant criteria are met. TME Pharma continuously evaluates ways to advance the clinical development of NOX-A12 while remaining focused on identifying and securing financial resources from multiple sources, including those having no or minimalutive effect on its shareholders, such as governmental grants or free supply of combination drugs. The company would prioritize such programs that support financial compensation for therapies leading to revenue generation, thus potentially reducing the financial needs of late-stage clinical development and also helping to generate real-world clinical evidence. Recently announced clearance by the FDA of TME Pharma'sInvestigational New Drug (IND) application for a Phase 2 study with NOX-A12 in glioblastoma, that the company plans to initiate later this year, was a pre requisite to having Fast Track designation granted by the FDA. Having Fast Track designation in addition to an open IND with an FDA-approved study design that addresses questions of dosing and contribution of components optimizes late phase development and offers an economically efficient model which further de-risks TME Pharma's glioblastoma program. Following IND approval, this Fast Track designation is an external validation of NOX-A12's potential to address the unmet need for glioblastoma patients. The necessary preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharmais aiming to initiate the new Phase 2 study as soon as the necessary resources from financial and industrial partners have been secured. Ankündigung • Mar 06
TME Pharma N.V. Announces FDA Clearance of Investigational New Drug (Ind) Application for Nox-A12 Phase 2 Trial in Brain Cancer TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)1 application for NOX-A12, TME Pharma'sCXCL12 inhibitor, for use in the treatment of aggressive adult brain cancer, glioblastoma. With the IND now open at the FDA, TME Pharmaplans to proceed with the continued clinical development of NOX-A12 in a Phase 2 randomized controlled study in approximately 100 newly diagnosed, chemotherapy-resistant glioblastoma patients having residual measurable tumor remaining after surgery. The study is expected to be initiated later this year, starting first in Europe, once the necessary resources and preparations are in place. Sufficient NOX-A12 clinical grade material has already been manufactured to initiate the study. The study will address questions of dosing and contribution of components – NOX-A12 and bevacizumab – to overall efficacy of the combination therapy and will allow TME Pharma to optimize late phase development by testing multiple doses of NOX-A12 with bevacizumab in a patient population that is also randomized to standard of care. Together with the IND submission TME Pharmahas also submitted a Fast-Track Designation2 request to the FDA to secure an expedited regulatory pathway for NOX-A12 in glioblastoma and the company expects to receive the FDA's decision before the end of March 2024. Based on discussions with the FDA last year and further interaction during the IND application process, the FDA-approved study design includes five arms, with 20 patients per arm: Arm 1: NOX-A12 - 200mg/week + radiotherapy and bevacizumab, Arm 2: NOX-A12 - 400mg/week + radiotherapy and bevacizumab, Arm 3: NOX-A12 - 600mg/week + radiotherapy and bevacizumab, Arm 4: NOX-A12 - 600mg/week + radiotherapy and Arm 5: Standard of Care control (temozolomide + radiotherapy). TME Pharma'sregulatory interactions were supported by recent survival data from the GLORIA Phase 1/2 study in which NOX-A12 demonstrated an unprecedented median Overall Survival (mOS) of 19.9 months in combination with bevacizumab and radiotherapy in glioblastoma patients with measurable chemotherapy-resistant residual tumors after surgery. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approx. 10 months, and exceeds what TME Pharmabelieves to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. Ankündigung • Feb 09
TME Pharma N.V. announced that it expects to receive €1.479999 million in funding TME Pharma N.V. announces private placement of 6,727,270 ordinary shares at an issue price of €0.22 per share for gross proceeds of €1,479,999.4 on February 9, 2024. The transaction is expected to close on February 12, 2024. Ankündigung • Jan 10
TME Pharma Announces Successful Advice Meeting with US Food and Drug Administration on Nox-A12 Development in Brain Cancer TME Pharma N.V. announced that it successfully completed its pre-IND advice meeting with the US regulator, the Food and Drug Administration (FDA), discussing plans for the further clinical development of NOX-A12 as a treatment of aggressive adult brain cancer, glioblastoma. Based on the feedback received, TME Pharma confirms that it is on track with preparations to file its Investigational New Drug (IND) application and the expedited regulatory pathway request on a timeline that will allow successful completion of both by the end of First Quarter 2024. Ankündigung • Dec 14
TME Pharma N.V. announced that it has received €2.7 million in funding On December 14, 2023, TME Pharma N.V. closed the transaction. The company has issued preferential subscription rights through the issuance of new shares with associated warrants for an amount of €2.7 million. Ankündigung • Oct 10
TME Pharma N.V. Provides Positive Update on 18-Month Survival for NOX-A12 Combination Regimen in Brain Cancer TME Pharma N.V. announced a positive update on survival at 18 months for patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy, and provides an overview on upcoming clinical development plans for NOX-A12 in the aggressive adult brain cancer, glioblastoma. The percentage of patients who were alive 18 months after start of therapy of NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy is currently 50% (with the possibility to increase to 67% with the next patient reaching 18 months) which exceeds by 10-fold the 18-month survival of 5% observed in the matched group of patients receiving standard of care1. Since neither bevacizumab (anti-VEGF) alone, nor bevacizumab plus radiotherapy have previously shown to extend survival, the strong increase in survival can be attributed to the complementary mechanism of action of NOX-A12 with bevacizumab and radiotherapy2. The survival rate of the NOX-A12 triple combination also exceeds the 18-month survival of 20% seen in the patients with high levels of the NOX-A12 predictive biomarker EG12 receiving NOX-A12 + radiotherapy alone3, which further supports NOX-A12’s potential to synergize with VEGF inhibition in glioblastoma . The median overall survival has now reached 18 months and is expected to improve further as the remaining patients continue to receive treatment or follow-up care4. Two of the three living patients are clinically stable despite radiographic tumor progression at last report from treating clinicians, including the patient who achieved complete response, now completing 22 months therapy. As a reminder, the matched standard of care reference cohort achieved a median overall survival of 10.5 months. The NOX-A12-based therapy has now delivered median overall survival exceeding all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients despite recruiting more difficult to treat patients whose tumors could not be fully removed by surgery5. NOX-A12 in combination with bevacizumab and radiotherapy continues to show an excellent safety and tolerability profile similar to that noted in previous publications. In the upcoming 6 months the key regulatory steps for NOX-A12 program in brain cancer will include the following: Fourth Quarter 2023 – Request advice in October from US Food and Drug Administration (FDA) on next trial design and eligibility for expedited regulatory pathways, such as Fast-Track Designation. Feedback expected in late December. First Quarter 2024 – Submit IND application for glioblastoma with the US FDA along with expedited regulatory pathway access request. Successful IND filing and feedback targeted by end of First Quarter 2024. TME Pharma plans to keep the market updated on the progress of these regulatory discussions. The goal is to have an FDA approved clinical trial protocol in glioblastoma with an expedited regulatory path by the beginning of April 2024 in order to secure the funding for the necessary clinical trial via partnership, investment or other strategic transaction types. Ankündigung • Sep 22
TME Pharma Announces Selection of Two Clinical Abstracts on the Ongoing NOX-A12 GLORIA Phase 1/2 Trial in Glioblastoma for Presentation at ESMO 2023 Congress and SNO 2023 Annual Meeting TME Pharma N.V. announced that two abstracts on the ongoing NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) were selected for presentation at upcoming international scientific conferences. The oral presentation at the European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain, on October 20-24, 2023, will highlight an in-depth analysis of how the combination of radiotherapy and NOX-A12 remodels the immune tumor microenvironment in first-line glioblastoma patients, featuring clinical data from the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO Congress website at 00.05 CEST on Monday, October 16, 2023. It will be available concurrently on the TME Pharma website. Title: Spatial remodeling of the immune tumor microenvironment after radiotherapy and CXCL12 inhibition in glioblastoma in the Phase 1/2 GLORIA trial. Speaker: Dr. Julian Layer Session: Mini Oral 508MO Lecture Time and Date:11.15-11.20 a.m. CEST, Saturday, October 21, 2023. The 2023 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Vancouver, Canada, on November 15-19, 2023, will feature a poster presentation with a clinical update from the ongoing GLORIA Phase 1/2 trial studying NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and anti-VEGF (bevacizumab). The full abstract will be published and made available on the SNO official journal Neuro-Oncologyon Friday, November 10, 2023.Title: Interim data on dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX-A12) and bevacizumab in glioblastoma from the first expansion arm of the Phase 1/2 GLORIA trial. Presenter: Prof. Frank Giordano, MD Session: Poster Session Session Time and Date: 7.30-9.30 p.m. PT, Friday, November 17, 2023. GLORIA (NCT04121455) is TMEPharma’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. OPTIMUS (NCT04901741) is TMEPharma’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. Ankündigung • Sep 13
Tme Pharma N.V. Announces NOX-A12 Combination Regimen with Bevacizumab: 17-Month Survival Rate Exceeds All Relevant Competitor Treatments Against Most Severe Form of Adult Brain Cancer TME Pharma N.V. announces that the median Overall Survival (mOS) and Overall Response Rate (ORR) for patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy has now exceeded what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. After 17 months on study (median), 67% of GLORIA expansion arm patients (4 of 6) are still alive. The median Overall Survival is expected to improve further as the remaining patients continue to receive treatment or follow-up care. The milestone in survival at 17 months is a crucial landmark since it means the NOX-A12-based therapy has surpassed the survival rates achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients. In addition, the NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor. Ankündigung • Jul 13
TME Pharma N.V. Provides Positive Data Update on Best Response to Therapy with First Complete Response in Glioblastoma, Bringing 50% of Patients in Expansion Arm to Complete or Near- Complete Response TME Pharma N.V. announced a positive clinical update on the best response to therapy, reporting one patient achieving complete response in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab, in first-line glioblastoma. One patient (out of 6) in the expansion arm with a previous best response of 89.9% tumor shrinkage has achieved complete response, meaning the tumor disappeared completely and was no longer detectable by MRI. The complete response comes in addition to 2 patients with reported near-complete reductions (>99%) in tumor size, leading to 50% of patients in the GLORIA trial expansion arm achieving a complete or near-complete response. In November 2022, TME Pharma announced interim results from the GLORIA expansion arm [2] that demonstrated: 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50% as measured by MRI. 5 of 6 patients (83%) achieved durable partial responses (PR) by mRANO criteria3, which take into account radiographic response as well as other factors such as the clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained. The triple combination was well tolerated and safe. No dose-limiting toxicities were observed. Ankündigung • Jun 30
TME Pharma N.V. Announces Positive 15-Month Survival Data from Gloria Expansion Arm Evaluating NOX-A12 in Combination with Radiotherapy and Bevacizumab in Glioblastoma TME Pharma N.V. announced a positive clinical update on the survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. After 15 months on study (median), 83% of GLORIA expansion arm patients (5 of 6) remain alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months. Ankündigung • Jun 16
TME Pharma N.V. Receives Investigational New Drug (IND) Approval for NOX-A12 From the US FDA TME Pharma N.V. announced that the US Food and Drug Administration (FDA), after reviewing the comprehensive submission, has approved the company’s Investigational New Drug (IND) application to evaluate the company’s lead asset NOX-A12 in a Phase 2 study in pancreatic cancer (OPTIMUS) in the United States. OPTIMUS is an open-label Phase 2 study designed to evaluate the safety and efficacy of NOX-A12 combined with anti-PD-1 pembrolizumab (Keytruda® from Merck) and two different chemotherapy regimens (nanoliposomal irinotecan/5-FU/Leucovorin or gemcitabine/nab-paclitaxel) in second-line pancreatic cancer. The study is expected to enroll approximately 70 patients in clinical sites in the US, as well as France and Spain, where the study has been previously approved. As announced in June 2022, TME Pharma is currently focusing its capabilities on the development of NOX-A12 in glioblastoma. Therefore, the OPTIMUS Phase 2 trial in second-line pancreatic cancer will be initiated once appropriate funding becomes available. NOX-A12 is currently being developed in GLORIA, a Phase 1/2 study evaluating NOX-A12 in combination with radiotherapy and with or without bevacizumab in first-line glioblastoma brain cancer (glioblastoma) patients with tumors resistant to standard chemotherapy (with unmethylated MGMT promoter). Interim data reported to date from GLORIA demonstrate that NOX-A12 has an excellent safety profile with extremely encouraging signs of efficacy showing an 83% rate of survival at 14 months in patients with detectable chemotherapy refractory tumor remaining after surgery. Ankündigung • May 30
TME Pharma N.V., Annual General Meeting, Jun 29, 2023 TME Pharma N.V., Annual General Meeting, Jun 29, 2023, at 13:30 Central European Standard Time. Location: At the offices of Freshfields Bruckhaus Deringer LLP, Strawinskylaan 10, 1077 XZ Amsterdam Netherlands Agenda: To consider the annual accounts for the year ending December 31, 2022, and the report of the board of directors for 2022. Ankündigung • May 26
TME Pharma N.V. Provides Positive Clinical Update and 14-Month Survival Data from Gloria Expansion Arm Evaluating Nox-A12 in Combination with Radiotherapy and Bevacizumab in Glioblastoma TME Pharma N.V. announced clinical update on survival of newly diagnosed glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. After 14 months on study (median), 83% of GLORIA expansion arm patients (5 of 6) are still alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months. The latest survival data from the treatment combination of NOX-A12 with radiotherapy and bevacizumab continues to validate therapeutic approach, demonstrates a highly encouraging trend towards prolonged overall survival and underlines the potential for superior benefit of this treatment combination for glioblastoma patients. Ankündigung • Jan 23
Tme Pharma Provides Clinical Update on the Gloria Expansion Arm Testing Nox-A12 in Combination with Radiotherapy and Bevacizumab in Patients with Glioblastoma TME Pharma N.V. announced a clinical update on survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, the CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. With a median follow-up to date of 10 months in this arm of the trial median overall survival (mOS) has not yet been reached, and five of six patients (83%) remain alive. The 10-month timepoint is an important landmark for assessment since this is the expected survival for patients with MGMT unmethylated tumors and incomplete resection. Price Target Changed • Apr 27
Price target decreased to €0.83 Down from €4.30, the current price target is provided by 1 analyst. New target price is 802% above last closing price of €0.092. Stock is down 80% over the past year. The company posted a net loss per share of €0.22 last year. Executive Departure • Jul 02
Member of Supervisory Board J. deBethizy has left the company On the 24th of June, J. deBethizy's tenure as Member of Supervisory Board ended. We don't have any record of a personal shareholding under deBethizy's name. A total of 2 executives have left over the last 12 months. Executive Departure • Jul 02
Independent Member of the Supervisory Board Bertram Köhler has left the company On the 25th of June, Bertram Köhler's tenure as Independent Member of the Supervisory Board ended. We don't have any record of a personal shareholding under Bertram's name. A total of 2 executives have left over the last 12 months. Is New 90 Day High Low • Jan 20
New 90-day high: €0.61 The company is up 43% from its price of €0.43 on 22 October 2020. The French market is up 14% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 48% over the same period. Is New 90 Day High Low • Dec 30
New 90-day high: €0.57 The company is up 9.0% from its price of €0.52 on 01 October 2020. The French market is up 17% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 27% over the same period. Is New 90 Day High Low • Nov 30
New 90-day high: €0.56 The company is up 11% from its price of €0.50 on 01 September 2020. The French market is up 13% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 27% over the same period. Is New 90 Day High Low • Oct 15
New 90-day low: €0.45 The company is down 3.0% from its price of €0.47 on 17 July 2020. The French market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period. 
