Manufacturing of clinical supply has been contracted and the drug supply is projected to be available in H2 2021. NOX-A12 Radiotherapy Clinical Trial in First Line Brain Cancer Patients The company plans to initiate the first clinical trial of NOX-E36 combinations testing safety in 2021. Aiming to obtain additional safety data prior to launching the pivotal trial, NOXXON is currently preparing to expand the number of patients at one of the tested dose levels. After careful assessment of risks associated with the global COVID-19 pandemic, the company has implemented risk mitigating steps that minimized the impact of the pandemic on the organization. +49 (0) 30 726 247 0 amangasarian@noxxon.com NewCap Arthur Rouillé Tél. arouille@newcap.fr, Sie erhalten auf FinanzNachrichten.de kostenlose Realtime-Aktienkurse von. NOXXON Pharma N.V. Aram Mangasarian, Ph.D., Président Directeur Général Tél. NOXXON plans to test NOX-E36 in patients with solid tumors both as a monotherapy and in combination. As a result of the above factors, the Group's loss before income tax increased by €9,546 thousand from €860 thousand in FY 2019 to €10,406 thousand in FY 2020 (thereof loss from operations amounting to €5,769 thousand in FY 2020 vs. €3,948 thousand in FY 2019, resulting in an operating cash outflow of €5,224 thousand in FY 2020 vs. €4,286 thousand in FY 2019). Personnel expenses included non-cash share-based payment expenses amounting to €111 thousand in 2020 and €54 thousand in 2019. NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), ein Biotechnologieunternehmen mit Fokus auf der Verbesserung von Krebstherapien durch gezielte Einwirkung auf die Tumormikroumgebung « La validation par le DSMB des données de sécurité de la dose la plus élevée de NOX-A12 dans cette étude de phase 1/2 chez des patients atteints d’un cancer du cerveau est une excellente nouvelle pour NOXXON. noxxon pharma: das data safety monitoring board bestÄtigt sicherheit und gibt zustimmung zur weiteren patientenrekrutierung in die letzte hochdosis-kohorte der nox-a12 phase-1/2-gehirntumorstudie NOX-A12 Radiotherapy in First Line Brain Cancer Patients These are described as forward-looking statements. The decrease in G&A expenses in 2020 was mainly driven by lower legal, consulting and audit fees as well as public and investor relations expenses compared to 2019, partly offset by higher personnel expenses. We are thrilled by the prospects that are waiting for NOXXON in 2021 and are more than ever convinced that our unique approach to target the tumour microenvironment can enhance the way cancer is treated," said Aram Mangasarian, CEO of NOXXON. Subsequent to December 31, 2020, the company raised an additional €6.4 million from a private placement. Importantly, no warrants or other option-like instruments were attached to the shares issued in these financings. Keytruda® est une marque déposée de Merck Sharp & Dohme Corp. https://www.linkedin.com/company/noxxon-pharma-ag. Les produits du portefeuille oncologique développé par NOXXON agissent sur le microenvironnement tumoral et le cycle immunitaire anticancéreux par la rupture de la barrière de protection tumorale et l’inhibition de la réparation tumorale. COVID-19 noxxon pharma n.v.: noxxon pharma: das data safety monitoring board bestÄtigt sicherheit und gibt zustimmung zur weiteren patientenrekrutierung in die letzte … Ces déclarations ne constituent pas des faits historiques. The Group succeeded in raising €14.5 million in 2020 from multiple sources, including private placements, exercises of outstanding warrants and the ASO financing vehicle. Le deuxième candidat médicament de la Société en phase clinique, le NOX-E36, agit sur le micro-environnement tumoral en ciblant le système immunitaire inné. Finance cost in FY 2020 and FY 2019 was non-cash, except for transaction costs of €123 thousand in 2020 borne by the Group in conjunction with its issuance of convertible bonds. When such non-cash share-based payment expenses are not taken into account, the remaining personnel expenses were €622 thousand in 2020 and €530 thousand in 2019. Nous sommes impatients de poursuivre l'étude de ce traitement prometteur, dont les données principales sont toujours attendues fin mai pour la deuxième cohorte et en novembre 2021 pour la troisième cohorte », commente Aram Mangasarian, PDG de NOXXON. Further, €998 thousand of finance cost related to the exercise of warrants by Yorkville, €878 thousand related to the cashless exercise of all remaining Acuitas warrants outstanding and €23 thousand related to the fair value adjustments of detachable warrants issued to Kreos, Yorkville and certain other investors and €3 thousand related to interest expense for lease liabilities. Clinical plans for NOX-E36 Throughout 2020 and to date, NOXXON has successfully advanced its Phase 1/2 dose-escalation study of NOX-A12 in first-line brain cancer patients in combination with radiotherapy, conducted in six clinical centers in Germany. Research and development (R&D) expenses increased from €2,108 thousand in FY 2019 to €4,017 thousand in FY 2020. +49 (0) 30 726 247 0 amangasarian@noxxon.com NewCap Arthur Rouillé Tél. This mechanism allows NOX-A12 to stimulate an increased immune response within the tumor, making the tumor microenvironment immunologically "hotter". La société ne prend aucun engagement de mettre à jour les informations et déclarations prospectives, qui ne représente que l'état des choses le jour de la publication. The company is pursuing various financing alternatives to secure future budget requirements, including outreach to well-known US healthcare investors, obtaining further funding from existing investors through additional funding rounds, seeking strategic partnering deals as well as merger or acquisition opportunities. NOXXON GIBT FREIGABE DER HÖCHSTEN DOSIS VON NOX-A12 IN DER PHASE-1/2-GEHIRNTUMORSTUDIE DURCH DAS DATA SAFETY MONITORING BOARD BEKANNT Berlin, Deutschland, 10. Max 1Mo. Despite the COVID-19 pandemic, the company has continued its clinical development and investment activities as planned with minimal delay or disruption. These financings combined with the potential of the ASO vehicle have extended the financial visibility to Q2 2022. Highlights for 2020 and 2021 Year-to-Date. Par ailleurs, l'association de NOX-A12 et d’une radiothérapie a reçu le statut de médicament orphelin aux États-Unis et dans l'Union Européenne pour le traitement de certains cancers du cerveau. L'Europe poursuit son déconfinement, l'Inde en proie à un variant "préoccupant", La peur de l'inflation pèse lourd sur les actions. NOXXON prévoit d’évaluer l’action de NOX-E36 chez les patients atteints de tumeurs solides, en monothérapie ainsi qu’en association. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. Wie bewerten Sie die aktuell angezeigte Seite? Cash secured in 2020 and 2021 combined with the available convertible bond financing vehicle has extended NOXXON's financial visibility to Q2 2022. "The year 2020 has been a year of resilience for NOXXON, that successfully continued its clinical development and activities while adapting to the health situation. The company completed recruitment of patients into the last of the three planned cohorts in April 2021. business wire: noxxon pharma: das data safety monitoring board bestÄtigt sicherheit und gibt zustimmung zur weiteren patientenrekrutierung in … It is NOXXON's key priority to ensure timely completion of the ongoing Phase 1/2 dose escalation trial and present top-line data in 2021. The formation and composition of the SAB reflect NOXXON's clinical development strategy as the company prepares to initiate a two-arm Phase 2 trial in pancreatic cancer in Europe and the US. NOXXON is also studying NOX-A12 in brain cancer in combination with radiotherapy which has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The current budget projects a cash need of approximately €1.5 million per month in 2021, including all planned activities for the ongoing NOX-A12 brain cancer trial, drug production and trial initiation of the upcoming NOX-A12 pancreatic cancer study as well as the NOX-E36 trial. NOXXON Pharma N.V.: Noxxon Pharma N.V. Reports 2020 Financial Results, https://www.businesswire.com/news/home/20210428005849/en/, NOXXON PHARMA-Aktie komplett kostenlos handeln - auf Smartbroker.de, NOXXON Pharma N.V.: NOXXON Announces Data Safety Monitoring Board Validates NOX-A12 Highest Dose in Phase 1/2 Brain Cancer Trial, NOXXON Pharma N.V.: NOXXON GIBT FREIGABE DER HÖCHSTEN DOSIS VON NOX-A12 IN DER PHASE-1/2-GEHIRNTUMORSTUDIE DURCH DAS DATA SAFETY MONITORING BOARD BEKANNT, NOXXON Pharma N.V.: NOXXON GIBT 1,2 MIO. When such non-cash share-based payment expenses are not taken into account, the remaining personnel expenses were €858 thousand in 2020 and €741 thousand in 2019. noxxon@trophic.eu, NewCap Arthur Rouillé NOXXON a présenté ces données au cours du congrès virtuel de l’ESMO en septembre 2020. Pre-clinical work comparing combination strategies for NOX-E36 in solid tumors to identify the most promising approaches are also advancing. NOXXON Pharma Aktie im Überblick: Realtimekurs, Chart, Fundamentaldaten, sowie aktuelle Nachrichten und Meinungen. Mai 2021, 18.00 Uhr MESZ – NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), ein Biotechnologieunternehmen mit Fokus auf der Verbesserung von Krebstherapien noxxon pharma n.v.: noxxon pharma: das data safety monitoring board bestÄtigt sicherheit und gibt zustimmung zur weiteren patientenrekrutierung in die letzte … NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today its financial results for the fiscal year ending December 31, 2020. In 2020, other operating income resulted from sale of raw materials, services provided, the derecognition of benefits waived and the derecognition of liability, as well as other income, mainly resulting from foreign exchange differences. Overall, the impact of the pandemic on the operations, clinical trials and finances has been manageable and was limited in scope. zeit aktuelle nachrichten; 30.04. noxxon pharma n.v.: noxxon gibt 1,2 mio. On December 31, 2019, a significant number of warrants linked to previous financings, that are subject to anti-dilution adjustments affecting exercise price and number of shares issued, were outstanding. In 2020, NOXXON successfully raised €14.5 million which allowed the company to advance its strategic goals. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication. Copyright © 2021 Surperformance. NOXXON's Key Financial Figures for Fiscal Year 2020 Compared to the Same Period in 2019, Net loss attributable to owners of the company, Net loss attributable to non-controlling interest, NOXXON's oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. Consultez la version source sur businesswire.com : https://www.businesswire.com/news/home/20210510005559/fr/, Votre image est trops volumineuse. NOXXON's lead program NOX-A12 has delivered final top-line data from a Keytruda combination trial in metastatic colorectal and pancreatic cancer patients published at the ESMO conference in September 2020 and based on the trial results, including overall survival and safety profile, further studies are being planned in pancreatic cancer. Consultez la version source sur businesswire.com : Je déclare être actionnaire de la société concernée, Le point sur les changements de recommandations à Paris, Renault : série de nominations chez Alpine, Alstom a vu Bombardier Transport peser sur sa rentabilité en 2020-2021, Phunware, Inc. : Roth Capital Partners favorable sur le dossier, CECONOMY : Opinion positive de Baader Bank, AAREAL BANK AG : Warburg Research maintient sa recommandation à l'achat, https://www.businesswire.com/news/home/20210510005559/fr/, Le dollar toujours sous pression, la livre sterling reste solide, Le pétrole monte un peu, reprise progressive des opérations pour Colonial. The continued support of investors willing to purchase shares in this manner is key for NOXXON to reduce reliance on instruments that have the potential to create divergent interests between various groups of investors. In February 2021, NOXXON appointed a Scientific Advisory Board (SAB) under the chairmanship of Dr. Jose Saro. To meet the needs of upcoming clinical trials leading to approval of NOX-A12, NOXXON has made investment commitments and initiated manufacturing of drug supply of NOX-A12. As a result, the company's capital structure has become less complex. amangasarian@noxxon.com, Trophic Communications Gretchen Schweitzer and Valeria Fisher In 2021 to date, the Group has raised further €6.4 million from a private placement. During 2020, Yorkville exercised a large portion of its detachable warrants and Acuitas executed its right to cashless exercise for all of its warrants. Finance income of €406 thousand resulted from the derecognition of conversion rights in connection with the ASO financing upon conversion of the bonds and of €12 thousand relating to the cashless exercise of warrants. NOXXON Pharma N.V. Aram Mangasarian, Ph.D., Président Directeur Général Tél. One of the most interesting aspects of final top-line data, published by Prof. Niels Halama at the European Society for Medical Oncology (ESMO) Congress in September 2020, was the updated overall survival data showing that three patients, including two receiving their fourth line of therapy for metastatic pancreatic cancer, had lived more than one year and one of them living for almost two years. Strong Cash Position on December 31, 2020 General and administrative (G&A) expenses decreased from €2,115 thousand in FY 2019 to €1,881 thousand in FY 2020. NOXXON ANNOUNCES DATA SAFETY MONITORING BOARD VALIDATES NOX-A12 HIGHEST DOSE IN PHASE 1/2 BRAIN CANCER TRIAL Berlin, Germany, May 10, 2021, 06.00 p.m. CEST -NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that an independent … Income tax expenses decreased to nil in FY 2020 from €1 thousand in FY 2019. Noxxon Pharma AG, NOXXON Pharma N.V. (EuroNext Growth Paris: ALNOX), ein Biotechnologieunternehmen mit Fokus auf der Verbesserung von Kreb… This strategic approach will enable NOXXON to choose the optimal regimen to move forward into a randomized, controlled pivotal study targeting market authorization application in 2026 and approval in 2027. Tous droits réservés. Tel. De plus, les données issues du traitement de la première cohorte d’un essai évaluant NOX-A12 en combinaison avec une radiothérapie chez des patients atteints d'un cancer du cerveau récemment diagnostiqué et qui ne pouvaient pas bénéficier d’une chimiothérapie standard, ont permis de mettre en évidence une réduction constante des tumeurs dans cette population de patients. Other operating income decreased from €279 thousand in FY 2019 to €147 thousand in FY 2020. Personnel expenses included non-cash share-based payment expenses amounting to €51 thousand in 2020 and €53 thousand in 2019. NOXXON Pharma N : annonce la finalisation du recrutement des patients de l'etude de phase 1/2 évaluant le NOX-A12 en association avec la radiotherapie dans le cancer du cerveau In 2020, NOXXON completed the clinical trial of the combination of NOX-A12 with Keytruda in heavily pre-treated metastatic micro-satellite stable pancreatic and colorectal cancer patients. In both, Fiscal Year 2020 (FY 2020) and Fiscal Year 2019 (FY 2019), NOXXON did not generate any revenues. Sur la base des résultats de cet essai, incluant les données de survie globale et le profil de sécurité de la thérapie, NOXXON entend mener d'autres études dans le cancer du pancréas. NOX-A12 Immunotherapy Chemotherapy in Second Line Pancreatic Cancer Patients NOXXON Pharma N.V. Aram Mangasarian, Ph.D. Chief Executive Officer. The trial initiation is planned for H2 2021 and its completion is expected in 2023. The company successfully raised €14.5 million in cash in 2020 through multiple private placements, exercises of outstanding warrants to purchase NOXXON's shares, and the Atlas Special Opportunities (ASO) financing vehicle of which €12.8 million is still available. Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. Noxxon Pharma N.V. Reports 2020 Financial Results 14.04.21 NOXXON Successfully Completes Patient Recruitment in Phase 1/2 Brain Cancer Study of NOX-A12 Plus Radiotherapy Manufacturing Drug Supply With its new Scientific Advisory Board, composed of eminent experts in pancreatic cancer, and a strong cash position, NOXXON is now in a perfect position to accelerate the development of its main drug candidate, NOX-A12, which showed promising results in its completed combination trial with Merck's Keytruda in pancreatic and colorectal cancer patients and has very recently advanced in the final phases of its Phase 1/2 dose-escalation study in combination with radiotherapy in first-line brain cancer patients. A trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit from standard chemotherapy has delivered preliminary data from the first cohort showing consistent tumor reductions. Finance cost of €3,153 thousand related to the ASO financing entered into in 2020 and reflected losses on initial recognition of convertible bonds, conversion losses and conversion right derivatives as well as transaction costs. Ce communiqué contient des déclarations prospectives ou des termes se rapportant aux développements futurs ou futurs, ainsi que les négations de telles formulations ou termes, ou une terminologie similaire. The SAB includes four leading pancreatic cancer experts: Dr. Elena Gabriela Chiorean, Dr. Eileen M. O'Reilly, Prof. Dr. Thomas T. W. Seufferlein and Dr. Daniel D. Von Hoff. With encouraging data from a previous study and with guidance of the SAB, NOXXON is preparing to initiate a two-arm clinical trial in pancreatic cancer. Tel. With its improved finances, NOXXON plans to restart clinical trials with NOX-E36. Current cash resources are projected to finance the company into November 2021 and with the resources of the ASO financing vehicle into May 2022. En neutralisant des chimiokines dans le microenvironnement tumoral, NOXXON développe une approche unique, pouvant être utilisée en combinaison avec d'autres approches thérapeutiques afin d’affaiblir les défenses de la tumeur contre le système immunitaire et renforcer l’effet du traitement. Foreign exchange losses increased from €4 thousand in FY 2019 to €18 thousand in FY 2020, due to a higher volume of purchases denominated in currencies other than Euro in FY 2020. Overall, data from this study confirmed NOX-A12's mechanism of action and demonstrated that as monotherapy, NOX-A12 penetrates the tumor tissue where it neutralizes its target. On top of the combination therapy of NOX-A12 plus anti-PD-1, the study will test two different standard of care chemotherapy treatments in second-line patients. The increase in R&D expenses in 2020 compared to 2019 was mainly due to higher costs for drug manufacturing, service fees and other costs related to clinical trials and preclinical testing. noxxon pharma n.v. : le comitÉ independant de surveillance et de suivi des donnÉes confirme l'utilisation de la dose la plus ÉlevÉe de nox-a12 dans l'Étude de … Further information can be found at: www.noxxon.com, Keytruda is a registered trademark of Merck Sharp Dohme Corp, https://www.linkedin.com/company/noxxon-pharma-ag. Tel. NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris : ALNOX), société de biotechnologie spécialisée dans le développement de traitements améliorés du cancer ciblant le microenvironnement tumoral (MET), annonce aujourd'hui que le comité indépendant de surveillance et de suivi des données (DSMB) a confirmé qu'il était sûr et approprié de poursuivre l'étude évaluant la dose la plus élevée de NOX-A12 en association avec la radiothérapie dans l'étude de phase 1/2 en cours chez des patients atteints d’un cancer du cerveau. The Group NOXXON Pharma N.V. and NOXXON Pharma AG does not expect to generate revenues from any product candidates currently in development, until the Group either signs a licensing agreement, obtains regulatory approval and commercializes its products, or enters into collaborative agreements with third parties. Investor Relations LifeSci … On December 31, 2020, the Group had cash resources of €10.3 million (compared to €1.4 million on December 31, 2019). L’approbation du DSMB de poursuivre cette étude fait suite à l'évaluation des données de sécurité stipulée dans le protocole de l'étude, et qui devait être menée après que les trois patients de la troisième et dernière cohorte aient atteint au moins quatre semaines de traitement par la dose la plus élevée. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. Anticipating that the ongoing Phase 1/2 trial data supports further development, NOXXON plans to initiate in 2022 a pivotal trial of NOX-A12 combined with radiotherapy in first line MGMT promoter-unmethylated glioblastoma patients vs. standard of care, with first market authorization application targeted for 2024 and approval for 2025. EUR KAPITALERHÖHUNG DURCH WANDLUNG VON AKTIENOPTIONSSCHEINEN DURCH KREOS CAPITAL UND ANDERE BESTEHENDE INVESTOREN BEKANNT, NOXXON Pharma N.V.: NOXXON Announces €1.2M Equity Raise Through Conversion of Warrants by Kreos Capital and Other Historical Investors, Impressum | AGB | Disclaimer | Datenschutz. Ces déclarations comprennent des projections et des estimations ainsi que les hypothèses sur lesquelles celles-ci reposent, des déclarations portant sur des projets, des objectifs, des intentions et des attentes concernant des résultats financiers, des événements, des opérations, des services futurs, le développement de produits et leur potentiel ou les performances futures. In addition, NOXXON also initiated NOX-E36 manufacturing for future clinical trials. eur kapitalerhÖhung durch wandlung von aktienoptionsscheinen durch kreos capital und andere bestehende investoren bekannt The Annual Report 2020, as approved by the management and supervisory boards on April 28, 2021, is available on NOXXON's website (www.noxxon.com). Cette étude clinique de phase 1/2 porte sur trois schémas posologiques de NOX-A12 (200, 400 et 600 mg/semaine), combinés à une radiothérapie par faisceau externe chez des patients atteints d'un cancer du cerveau récemment diagnostiqué. Glow LifeTech: Weitere positive Studien für das COVID-Wundermittel ArtemiC?! NOXXON ANNOUNCES DATA SAFETY MONITORING BOARD VALIDATES NOX-A12 HIGHEST DOSE IN PHASE 1/2 BRAIN CANCER TRIAL Berlin, Germany, May 10, 2021, 06.00 p.m. CEST - NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that an independent … View source version on businesswire.com: https://www.businesswire.com/news/home/20210428005849/en/, NOXXON Pharma N.V. Aram Mangasarian, Ph.D., Chief Executive Officer +49 (0) 30 726247 0 Plus d’informations sont disponibles sur : www.noxxon.com. Top-line data from the second cohort will be reported in May 2021 and the one from the third cohort later in November 2021. Son programme principal, NOX-A12, a d’ores et déjà généré des données cliniques finales significatives à l’issue d'un essai de combinaison Keytruda® chez des patients atteints de cancer colorectal et pancréatique métastatique. By neutralizing chemokines in the TME, NOXXON's approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Tel. +33 (0) 1 44 71 00 15 NOX-A12 Immunotherapy Clinical Trial in Heavily Pre-Treated Metastatic Pancreatic and Colorectal Cancer Patients Scientific Advisory Board On December 31, 2020, NOXXON had cash resources of €10.3 million. Palantir autorise les paiements en bitcoins et envisage d'investir dans les crypto-monnaies. Preliminary data from the first dose group showed tumor reductions in all three patients, with one patient achieving a durable longer than four months objective response (tumor volume reduction of >50%). Finance income (all non-cash) decreased from €3,091 thousand in FY 2019 to €418 thousand in FY 2020. The company's second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. +49 (0) 30 726 247 0. amangasarian@noxxon.com. These financings were essential to allow NOXXON to complete the NOX-A12/Keytruda trial in pancreatic and colorectal cancer patients, to progress the NOX-A12/radiotherapy combination trial in brain cancer patients and to initiate manufacturing of NOX-A12 and NOX-E36 for upcoming clinical trials. In the second part of the study, when NOX-A12 was then combined with Merck's anti-PD-1 immunotherapeutic antibody, Keytruda, 25% of patients achieved stable disease according to the iRECIST criteria, despite only 5% having any response to their prior anti-cancer treatment before entering the NOXXON clinical trial. +49 (0) 172 861 8540 and +49 (0) 175 804 1816