Financing led by Novo Holdings with participation from Cargill and ER Capital Holdings AMSilk to accelerate industrial scale-up and expand commercial operations into new markets AMSilk GmbH (“AMSilk”), the world’s first industrial supplier of synthetic silk biopolymers, today announces the successful closing of a EUR 29 million Series C fundraise. The financing was led by Novo Growth, the growth equity arm of Novo Holdings, with participation from new investors Cargill and E.R. Capital Holdings as well as existing investors MIG Verwaltungs AG and ATHOS KG. AMSilk is a world leader in supplying innovative high-performance bio-based silk materials with a vision to use its proprietary technology platform to lead the change to better and more sustainable products. Its products are made from plant-based raw material via bacterial fermentation, are extremely versatile with extraordinary mechanical and biochemical properties, and have applications across many industries. The environmentally friendly, sustainable silk biopolymers can be fully recycled and are 100% biodegradable. These materials are revolutionizing products such as high-performance sports clothing as well as driving state-of-the-art biomedical developments including medical implants. The financing will accelerate the ongoing scale-up of AMSilk’s industrial projects worldwide and drive further the internationalization of its commercial activities as it continues to expand its customer base into new markets. Ulrich Scherbel, Chief Executive Officer of AMSilk, said: “Together with our customers we work to create high-performance bio-based materials with the potential to revolutionize product offerings and drive change across various industries. It is exciting to have the support from high-technology investors, led by Novo Holdings, to make our silk polymers available in industrial quantities to an even broader range of customers and industries.” Dr Wolfgang Colberg, Chairman of the Advisory Board, added: “With the inspiring support of our new and existing shareholders we are in a strong position to establish AMSilk as one of the leading bio-materials companies in the world.” Kartik Dharmadhikari, Partner at Novo Growth, stated: “AMSilk’s technology has the potential to revolutionize a number of industries and be part of the decarbonization push needed to overcome the biggest environmental challenges of our time. The company has made immense progress in enhancing its high-performance bio-based materials and we are delighted to lead this financing which will enable them to expand the business globally. This investment underscores Novo Holdings’ commitment to backing companies that will have a long-term, sustainable impact on society.” Asheesh Choudhary, Global Business Development Director, Bioindustrial at Cargill, added: “The apparel industry is demanding bio-based materials that are good for people and the planet. We are excited by AMSilk’s innovation as it offers a sustainable and functional product to its customers. We are investing in AMSilk because our strategic interests are well aligned, and we are happy to be a part of enabling its growth.” On behalf of the existing shareholders, Melissa Simon, ATHOS KG, stated: “As original investors in the company, we have witnessed the immense progress achieved to date and look forward to continuing to support AMSilk delivering on its vision.” Michael Motschmann, General Partner at MIG AG, added: “As an AMSilk seed investor, we are proud of the great strides the company has made since inception. Our continued investment in AMSilk mirrors our vision to invest in early biotech and deep tech companies and advance innovations that can move the world forward.” Kartik Dharmadhikari, Partner, Anders Bendsen Spohr, Senior Partner at Novo Holdings, and Melissa Simon from ATHOS KG, will join the Supervisory Board.

Neurodermitis ist eine der am meisten verbreiteten chronischen Hauterkrankungen. Quälender Juckreiz, trockene Haut und Rötungen machen Neurodermitis-Patienten das Leben schwer. Hier setzt die Neurodermitis App Nia an: Sie unterstützt die chronisch Erkrankten und ihre Angehörigen Tag für Tag durch vollumfängliche digitale Begleitung – in Ergänzung zu etablierten Therapien. In Nia können beispielsweise potentielle Schub-Auslöser dokumentiert werden. Anwender erhalten außerdem viele praktisch anwendbare Tipps und Hintergrundwissen rund um die Themen Medikamente, Ernährung, Psychologie und Körperpflege. Die wissenschaftlich validierten Inhalte basieren auf dem renommierten Curriculum des AGNES e.V. Die preisgekrönte App ist die meistgenutzte Neurodermitis-App im deutschsprachigen Raum, sowie die erste als Medizinprodukt zugelassene App dieser Art überhaupt. Sie wurde von dem Berliner Startup Nia Health, einem Spin-Off der Charité Universitätsmedizin Berlin, im Jahr 2019 ins Leben gerufen. Mit Sanofi Genzyme erhält die App nun einen weiteren starken Partner: Ab sofort ist die Specialty Care Business Unit von Sanofi Sponsoring-Partner und unterstützt die als Medizinprodukt der Klasse I zugelassene Neurodermitis App Nia im Rahmen eines Sponsorings. Gründer und Geschäftsführer von Nia Health, Tobias Seidl, zeigt sich über die Unterstützung sehr erfreut: „Mit der finanziellen Unterstützung von Sanofi Genzyme können wir unsere patientenzentrierte Produktentwicklung noch weiter ausbauen. Das Vertrauen eines so erfolgreichen Unternehmens zu erhalten, motiviert uns enorm.“ Peter Kuiper, General Manager bei Sanofi Genzyme GSA, erklärt Sanofi Genzymes Engagement bei Nia Health wie folgt: „Es liegt uns bei Sanofi Genzyme am Herzen, den Alltag von Betroffenen mit Neurodermitis zu erleichtern. Die Nia App leistet einen wertvollen Beitrag in der Begleitung der individuellen Behandlung dieser chronischen Hauterkrankung und wir freuen uns ganz besonders hier unterstützen zu können.“ Über Sanofi Genzyme: Sanofi Genzyme, die globale Specialty Care Business Unit von Sanofi, konzentriert sich auf die Entwicklung von wegweisenden Behandlungen bei seltenen und komplexen Erkrankungen, um Patientinnen, Patienten und ihren Familien neue Hoffnung zu geben. Die Immunologie ist ein Bereich, in dem Sanofi Genzyme starkes Wachstum verzeichnet und in dem das Unternehmen hofft, einen entscheidenden Unterschied im Leben der Patientinnen und Patienten zu machen. Sanofi Genzyme hat sich zum Ziel gesetzt, Antworten auf die noch offenen Fragen bei Immunerkrankungen wie atopische Dermatitis, Asthma und chronische Sinusitis zu finden. Sanofi Genzyme ist als einer der führenden Biologika-Hersteller mit dem Medikament Dupilumab seit kurzem auch für die Behandlung von Kindern ab sechs Jahren zugelassen. Die Leitlinie für Neurodermitis enthält seit Januar dieses Jahrs eine entsprechende Empfehlung. www.sanofi.de Über Nia Health: Nia Health bietet Patientinnen und Patienten mit chronischen Erkrankungen mithilfe innovativer medizinischer Software vollumfängliche digitale Unterstützung. Der Medizinproduktehersteller entstand 2019 aus einer Ausgründung der Charité Berlin. Ihr erstes Produkt, die preisgekrönte Neurodermitis App Nia, bietet tausenden Patientinnen, Patienten und Angehörigen tägliche Unterstützung. Nia ist inzwischen die meistgenutzte Neurodermitis App im deutschsprachigen Raum. Außerdem ist Nia die erste als Medizinprodukt zugelassene Neurodermitis-App überhaupt. Nia wird bereits von führenden gesetzlichen Krankenkassen empfohlen. Im Oktober 2020 wurde mit der Psoriasis App Sorea das zweite Produkt auf Basis der innovativen Technologie der Berliner in den Markt eingeführt.

Post-hoc analysis reveals clinically meaningful and statistically significant improvement in eGOS when ronopterin is infused within 12 hours after trauma vasopharm will communicate next steps after discussing these results with Competent Authorities Trial did not meet its primary endpoint Further results to be published in a peer-reviewed journal Currently there are no approved treatments for patients with moderate and severe traumatic brain injury   vasopharm GmbH, a privately-held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, today announces that the NOSTRA III traumatic brain injury (TBI) Phase III clinical trial of ronopterin (VAS203) did not meet the pre-specified primary endpoint of improvement in extended Glasgow Outcome Scale (eGOS) at six months after trauma. Importantly, hypothesis driven post-hoc analysis reveals a statistically significant and clinically meaningful increase in eGOS over time in patients with moderate and severe TBI when ronopterin is infused within 12 hours after trauma. The NOSTRA III trial (NO Synthase in TRAumatic Brain Injury; clinicaltrials.gov identifier NCT02794168) is a pivotal European trial assessing the efficacy and safety of ronopterin for the treatment of patients with moderate and severe TBI. Current therapeutic approaches to acute TBI are predominantly supportive measures, initiated reactively, to decrease elevated intracranial pressure with the aim of reducing mortality and morbidity. To date, no specific pharmacologic intervention has been demonstrated to improve long-term physical and cognitive recovery. The NOSTRA III trial is a placebo-controlled, randomised, double-blind, multi-centre study in five countries at 29 investigational sites in Austria, France, Germany, Spain and the UK. In total 224 eligible patients were enrolled. Ronopterin is the first drug which simultaneously targets blood vessels and tissue of the injured brain by reducing the excessive production of nitric oxide via upregulated inducible NO synthase (iNOS). Professor Dr John Stover, Chief Medical Officer of vasopharm, explained: “While NOSTRA III did not achieve statistical significance in the pre-specified primary endpoint of eGOS at six months after trauma, we performed a detailed hypothesis driven post-hoc analysis guided by pathophysiology combined with biochemistry and pharmacology. This analysis clearly reveals the potential of ronopterin to benefit patients when infused within the initial 12 hours after TBI. Ronopterin was associated with a higher median eGOS at 3 and 6 months vs placebo (3 months: eGOS 5 vs 4; 6 months: eGOS 6 vs 5, respectively), a larger proportion of patients with good recovery, i.e. eGOS 7 and 8 at 6 months (37% vs 23%), and a significantly higher odds ratio in patients with an increase in eGOS from 3 to 6 months (2.98; p=0.039). The Number Needed to Treat is calculated at 7 for patients with a good recovery (eGOS 7 and 8) and 4 for patients with an increase in eGOS over time. These post-hoc results of the NOSTRA III trial corroborate the positive results of the dose-finding NOSTRA II study. This efficacy, in the opinion of the Data Monitoring Committee, clearly outweighs the known adverse event profile, resulting in a positive benefit-risk assessment. We consider these results robust and clinically relevant, and vasopharm will seek scientific advice from Competent Authorities on the further regulatory pathway for ronopterin.” Frank Tegtmeier, PhD, Chief Scientific Officer of vasopharm, commented: “We are pleased that we have identified a clinically coherent explanation for the results of the pre-specified analysis and that we can provide a clear rationale for the beneficial use of ronopterin in patients with moderate and severe TBI. The early infusion and trajectory of improvement over time are supported by recent publications of observational studies and randomised controlled Phase III trials.” Prof. Dr. Erich Schmutzhard, Medical University of Innsbruck, Austria and Chief Investigator for the NOSTRA III trial, said:  “The demanding complexity of traumatic brain injury is well known, every injury is different. Experience shows us that not all patients will benefit from interventions and treatment approaches we deem helpful. In this difficult clinical context, it is remarkable that ronopterin resulted in a significantly higher number of patients with signs of improved recovery. Ronopterin is the first drug to potentially offer a new and advanced treatment option to patients with acute moderate and severe TBI. The early infusion will be easy to integrate in our daily emergency and intensive care routine.” NOSTRA III’s primary endpoint is the extended Glasgow Outcome Scale (eGOS) at six months post trauma; the eGOS at three months after TBI is one of the secondary endpoints. The combination of these primary and secondary endpoints allows evaluation of the trajectory of neurologic recovery during the first six months after TBI, reflecting a clinically important measure and timeframe.