TME Pharma（ALTME）株式概要TME Pharma N.V.は臨床段階にあるバイオ医薬品会社で、ドイツでがん治療のための独自の治療薬の開発に注力している。 詳細ALTME ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6報酬過去5年間の収益は年間23.9%増加しました。 リスク分析収益が 100 万ドル未満 ( €0 )キャッシュランウェイが1年未満である 意味のある時価総額がありません ( €6M )マイナスの株主資本 +1 さらなるリスクすべてのリスクチェックを見るALTME Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW489,735 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG489,735 investors already sharing narrativesYour Fair Value€Current Price€0.064該当なし内在価値ディスカウントEst. Revenue$PastFuture-16m472k2016201920222025202620282031Revenue €0.05Earnings €0.008AdvancedSet Fair ValueView all narrativesTME Pharma N.V. 競合他社AtonSymbol: ENXTPA:ALTAOMarket cap: €8.4mPlant Advanced TechnologiesSymbol: ENXTPA:ALPATMarket cap: €7.5mNicoxSymbol: ENXTPA:ALCOXMarket cap: €32.7mgenOway Société anonymeSymbol: ENXTPA:ALGENMarket cap: €23.7m価格と性能株価の高値、安値、推移の概要TME Pharma過去の株価現在の株価€0.06452週高値€0.1252週安値€0.049ベータ0.641ヶ月の変化-13.23%3ヶ月変化-15.98%1年変化-41.22%3年間の変化-95.42%5年間の変化-99.82%IPOからの変化-99.90%最新ニュースNew Risk • May 18New minor risk - Financial data availabilityThe 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).お知らせ • Apr 18TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature CommunicationsTME 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 19New major risk - Share price stabilityThe 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 04New major risk - Negative shareholders equityThe 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).お知らせ • Sep 22TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025New Risk • Jul 03New major risk - Share price stabilityThe 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).最新情報をもっと見るRecent updatesNew Risk • May 18New minor risk - Financial data availabilityThe 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).お知らせ • Apr 18TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature CommunicationsTME 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 19New major risk - Share price stabilityThe 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 04New major risk - Negative shareholders equityThe 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).お知らせ • Sep 22TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025New Risk • Jul 03New major risk - Share price stabilityThe 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).お知らせ • Jun 25Tme Pharma N.V. Appoints Diede Mink Van Den Ouden as Sole Member of the Board of DirectorsTME 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.お知らせ • May 05+ 1 more updateAram Mangasarian to Step Down as CEO of TME Pharma N.VTME Pharma N.V. announced a strategic change to facilitate ongoing efforts to finance the next clinical trial for NOX-A12 through agreements with pharma or financial partners. The strategy will involve the nomination of Diede van den Ouden as the new CEO of TME Pharma N.V. at the upcoming annual general meeting of shareholders (AGM) in June 2025. Diede van den Ouden will bring to TME Pharma his experience in managing and advising listed companies and taking companies through financial reorganization, in particular with Tonner Drones and Lavide Holding. Van de Ouden is currently a TME Pharmashareholder. Aram Mangasarian will step down as CEO following appointment of Diede Van de Ouden, but will continue to advise the company on a consulting basis on scientific and strategic matters.お知らせ • Dec 05TME 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お知らせ • Nov 01TME Pharma Receives €2.4 Million German Federal Ministry of Education and Research Grant to Support NOX-A12 Phase 2 Trial in Brain CancerTME 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.お知らせ • Oct 18TME Pharma N.V. Provides Clinical UpdateTME 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.お知らせ • Oct 01TME Pharma N.V. Announces Appointment of Alexandra Glucksmann to Supervisory BoardTME 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.お知らせ • Jun 28TME Pharma N.V. Appoints Lee Schalop as Member of the Supervisory BoardTME 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 28New major risk - Negative shareholders equityThe 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).お知らせ • Apr 23TME 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 CancerTME 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.お知らせ • Apr 03TME Pharma N.V. Receives US FDA Fast Track Designation for Lead Asset NOX-A12 in Brain CancerTME 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.お知らせ • Mar 06TME Pharma N.V. Announces FDA Clearance of Investigational New Drug (Ind) Application for Nox-A12 Phase 2 Trial in Brain CancerTME 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.お知らせ • Feb 09TME Pharma N.V. announced that it expects to receive €1.479999 million in fundingTME 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.お知らせ • Jan 10TME Pharma Announces Successful Advice Meeting with US Food and Drug Administration on Nox-A12 Development in Brain CancerTME 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.お知らせ • Dec 14TME Pharma N.V. announced that it has received €2.7 million in fundingOn 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.お知らせ • Oct 10TME Pharma N.V. Provides Positive Update on 18-Month Survival for NOX-A12 Combination Regimen in Brain CancerTME 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.お知らせ • Sep 22TME 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 MeetingTME 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.お知らせ • Sep 13Tme 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 CancerTME 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.お知らせ • Jul 13TME 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 ResponseTME 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.お知らせ • Jun 30TME Pharma N.V. Announces Positive 15-Month Survival Data from Gloria Expansion Arm Evaluating NOX-A12 in Combination with Radiotherapy and Bevacizumab in GlioblastomaTME 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.お知らせ • Jun 16TME Pharma N.V. Receives Investigational New Drug (IND) Approval for NOX-A12 From the US FDATME 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.お知らせ • May 30TME Pharma N.V., Annual General Meeting, Jun 29, 2023TME 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.お知らせ • May 26TME 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 GlioblastomaTME 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.お知らせ • Jan 23Tme Pharma Provides Clinical Update on the Gloria Expansion Arm Testing Nox-A12 in Combination with Radiotherapy and Bevacizumab in Patients with GlioblastomaTME 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 27Price target decreased to €0.83Down 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.分析記事 • Dec 20Will NOXXON Pharma (EPA:ALNOX) Spend Its Cash Wisely?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...分析記事 • Sep 06We're Keeping An Eye On NOXXON Pharma's (EPA:ALNOX) Cash Burn RateJust because a business does not make any money, does not mean that the stock will go down. For example, although...Executive Departure • Jul 02Member of Supervisory Board J. deBethizy has left the companyOn 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 02Independent Member of the Supervisory Board Bertram Köhler has left the companyOn 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.分析記事 • May 19Is NOXXON Pharma (EPA:ALNOX) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...分析記事 • Feb 01NOXXON Pharma (EPA:ALNOX) Is In A Good Position To Deliver On Growth PlansThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...Is New 90 Day High Low • Jan 20New 90-day high: €0.61The 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 30New 90-day high: €0.57The 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 30New 90-day high: €0.56The 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 15New 90-day low: €0.45The 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.株主還元ALTMEFR BiotechsFR 市場7D-5.2%-2.6%0.1%1Y-41.2%324.0%2.5%株主還元を見る業界別リターン: ALTME過去 1 年間で324 % の収益を上げたFrench Biotechs業界を下回りました。リターン対市場: ALTMEは、過去 1 年間で2.5 % のリターンを上げたFrench市場を下回りました。価格変動Is ALTME's price volatile compared to industry and market?ALTME volatilityALTME Average Weekly Movement6.9%Biotechs Industry Average Movement7.9%Market Average Movement4.7%10% most volatile stocks in FR Market10.5%10% least volatile stocks in FR Market2.3%安定した株価: ALTMEの株価は、 French市場と比較して過去 3 か月間で変動しています。時間の経過による変動: ALTMEの weekly volatility ( 7% ) は過去 1 年間安定していますが、依然としてFrenchの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト199712Diede van den Oudenwww.tmepharma.comTME Pharma N.V.は臨床段階のバイオ医薬品会社で、ドイツでがん治療のための独自の治療薬の開発に注力している。同社のSpiegelmerプラットフォームは、臨床段階にある製品候補の独自のパイプラインを有しており、その中には、転移性膵臓がん、大腸がん、神経膠芽腫、骨髄腫など様々ながん適応症の併用療法として開発中の主要ながん治療薬候補NOX-A12が含まれている。また、NOX-E36の開発も進めており、糖尿病性腎症の治療薬として第1/2相臨床試験を終了している。同社は以前はNOXXON Pharma N.V.として知られていたが、2022年7月にTME Pharma N.V.に社名を変更した。TME Pharma N.V.は1997年に設立され、ドイツのベルリンに本社を置いている。もっと見るTME Pharma N.V. 基礎のまとめTME Pharma の収益と売上を時価総額と比較するとどうか。ALTME 基礎統計学時価総額€5.98m収益（TTM）-€3.28m売上高(TTM)n/a0.0xP/Sレシオ-1.8xPER（株価収益率ALTME は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ALTME 損益計算書（TTM）収益€0売上原価€0売上総利益€0その他の費用€3.29m収益-€3.28m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.035グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率-151.2%ALTME の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/19 21:12終値2026/07/17 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋TME Pharma N.V. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Jean-Pierre LozaIn Extenso Financement & Marché
New Risk • May 18New minor risk - Financial data availabilityThe 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).
お知らせ • Apr 18TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature CommunicationsTME 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 19New major risk - Share price stabilityThe 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 04New major risk - Negative shareholders equityThe 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).
お知らせ • Sep 22TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025
New Risk • Jul 03New major risk - Share price stabilityThe 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).
New Risk • May 18New minor risk - Financial data availabilityThe 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).
お知らせ • Apr 18TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature CommunicationsTME 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 19New major risk - Share price stabilityThe 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 04New major risk - Negative shareholders equityThe 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).
お知らせ • Sep 22TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025
New Risk • Jul 03New major risk - Share price stabilityThe 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).
お知らせ • Jun 25Tme Pharma N.V. Appoints Diede Mink Van Den Ouden as Sole Member of the Board of DirectorsTME 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.
お知らせ • May 05+ 1 more updateAram Mangasarian to Step Down as CEO of TME Pharma N.VTME Pharma N.V. announced a strategic change to facilitate ongoing efforts to finance the next clinical trial for NOX-A12 through agreements with pharma or financial partners. The strategy will involve the nomination of Diede van den Ouden as the new CEO of TME Pharma N.V. at the upcoming annual general meeting of shareholders (AGM) in June 2025. Diede van den Ouden will bring to TME Pharma his experience in managing and advising listed companies and taking companies through financial reorganization, in particular with Tonner Drones and Lavide Holding. Van de Ouden is currently a TME Pharmashareholder. Aram Mangasarian will step down as CEO following appointment of Diede Van de Ouden, but will continue to advise the company on a consulting basis on scientific and strategic matters.
お知らせ • Dec 05TME 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
お知らせ • Nov 01TME Pharma Receives €2.4 Million German Federal Ministry of Education and Research Grant to Support NOX-A12 Phase 2 Trial in Brain CancerTME 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.
お知らせ • Oct 18TME Pharma N.V. Provides Clinical UpdateTME 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.
お知らせ • Oct 01TME Pharma N.V. Announces Appointment of Alexandra Glucksmann to Supervisory BoardTME 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.
お知らせ • Jun 28TME Pharma N.V. Appoints Lee Schalop as Member of the Supervisory BoardTME 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 28New major risk - Negative shareholders equityThe 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).
お知らせ • Apr 23TME 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 CancerTME 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.
お知らせ • Apr 03TME Pharma N.V. Receives US FDA Fast Track Designation for Lead Asset NOX-A12 in Brain CancerTME 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.
お知らせ • Mar 06TME Pharma N.V. Announces FDA Clearance of Investigational New Drug (Ind) Application for Nox-A12 Phase 2 Trial in Brain CancerTME 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.
お知らせ • Feb 09TME Pharma N.V. announced that it expects to receive €1.479999 million in fundingTME 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.
お知らせ • Jan 10TME Pharma Announces Successful Advice Meeting with US Food and Drug Administration on Nox-A12 Development in Brain CancerTME 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.
お知らせ • Dec 14TME Pharma N.V. announced that it has received €2.7 million in fundingOn 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.
お知らせ • Oct 10TME Pharma N.V. Provides Positive Update on 18-Month Survival for NOX-A12 Combination Regimen in Brain CancerTME 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.
お知らせ • Sep 22TME 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 MeetingTME 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.
お知らせ • Sep 13Tme 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 CancerTME 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.
お知らせ • Jul 13TME 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 ResponseTME 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.
お知らせ • Jun 30TME Pharma N.V. Announces Positive 15-Month Survival Data from Gloria Expansion Arm Evaluating NOX-A12 in Combination with Radiotherapy and Bevacizumab in GlioblastomaTME 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.
お知らせ • Jun 16TME Pharma N.V. Receives Investigational New Drug (IND) Approval for NOX-A12 From the US FDATME 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.
お知らせ • May 30TME Pharma N.V., Annual General Meeting, Jun 29, 2023TME 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.
お知らせ • May 26TME 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 GlioblastomaTME 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.
お知らせ • Jan 23Tme Pharma Provides Clinical Update on the Gloria Expansion Arm Testing Nox-A12 in Combination with Radiotherapy and Bevacizumab in Patients with GlioblastomaTME 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 27Price target decreased to €0.83Down 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.
分析記事 • Dec 20Will NOXXON Pharma (EPA:ALNOX) Spend Its Cash Wisely?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
分析記事 • Sep 06We're Keeping An Eye On NOXXON Pharma's (EPA:ALNOX) Cash Burn RateJust because a business does not make any money, does not mean that the stock will go down. For example, although...
Executive Departure • Jul 02Member of Supervisory Board J. deBethizy has left the companyOn 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 02Independent Member of the Supervisory Board Bertram Köhler has left the companyOn 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.
分析記事 • May 19Is NOXXON Pharma (EPA:ALNOX) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...
分析記事 • Feb 01NOXXON Pharma (EPA:ALNOX) Is In A Good Position To Deliver On Growth PlansThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
Is New 90 Day High Low • Jan 20New 90-day high: €0.61The 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 30New 90-day high: €0.57The 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 30New 90-day high: €0.56The 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 15New 90-day low: €0.45The 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.
