FRANKFURT, GERMANY, NEW YORK, USA – January 19, 2024 : SkylineDx and NeraCare today announced that they will not continue their strategic partnership. The initial intent was to identify and collaborate in areas where the companies would have synergies for further assay development and optimization of NeraCare's IHC assay. After an evaluation phase both companies jointly concluded that they will proceed independently. About SkylineDx SkylinDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com. About NeraCare NeraCare is a developer of laboratory tests for individualized survival prediction of melanoma patients with offices in Frankfurt, Germany and New York, USA. The current portfolio includes two assays: (i) immunoprint®, an immunohistochemistry-based assay which identifies patients with early-stage melanoma who are at high-risk of relapse and death and (ii) MelaGenix®, a gene-expression-based assay which was used as an inclusion criterion in the NivoMela trial. NivoMela is the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse.

FRANKFURT , and NEW YORK , 26 April 2023 - NeraCare, a leading developer of laboratory tests for personalized survival prediction of melanoma patients, has announced a strategic partnership with SkylineDx, a biotechnology company that focuses on research and development of molecular diagnostics. The agreement includes an exclusive co-development and licensing agreement for Immunoprint®, a proteomic test used to identify early-stage melanoma patients at high risk of relapse and death. Melanoma is a severe form of skin cancer that can quickly spread, resulting in the majority of skin cancer-related deaths. While recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy, a large group of early-stage patients still lack access to these life-saving therapies, accounting for most of melanoma deaths. Immunoprint® has the potential to help solve this problem. The anticipated impact of Immunoprint® was recently highlighted at the 2023 European Association of Dermato-Oncology (EADO) Congress. Across multiple, independent prospective and archival validation studies, Immunoprint showed a significant improvement of individualized risk prediction beyond the current melanoma staging system (AJCC8 )." Immunoprint has the potential to select melanoma patients at high risk of relapse and death, with high precision, and therefore allows a highly personalized adjuvant treatment approach already in early-stage melanoma”," said Dr. Dirk Schadendorf, Director of the West German Comprehensive Cancer Center at University Hospital Essen. Under the agreement, SkylineDx will lead the commercialization of Immunoprint®, while NeraCare will receive royalty payments. "We are thrilled to partner with SkylineDx, given their proven track record in successful R&D programs and a highly capable team to bring innovative diagnostic solutions to market," said Daniel von Janowski and Friedrich Ackermann, Co-Founders of NeraCare. "This partnership marks a significant milestone for SkylineDx as the world continues to move towards personalized care, and away from one-size-fits-all approaches to medicine. The team at NeraCare has made great progress in melanoma risk stratification," commented Jvalini Dwarkasing, CSO of SkylineDx. "Through this collaboration, we anticipate to accelerate the development of precision diagnostics and treatment for patients with this life-threatening disease." With the news of this announcement the combined efforts of NeraCare and SkylineDx will focus on setting up a phase III clinical trial that will randomize high-risk early-stage melanoma patients to receive drug treatment. If successful, this clinical trial could potentially provide access to drug treatment for up to 28,000 early-stage melanoma patients globally every year. This would further add to the already significant breakthroughs in adjuvant melanoma therapy in recent history and provide hope for many patients. ABOUT NERACARE : NeraCare is a developer of laboratory tests for individualized survival with offices in Frankfurt and New York. In addition to Immunoprint®, the company markets the gene expression-based assay MelaGenix®, which was used in the phase III NivoMela trial , the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse. The company has raised close to $15 million in venture capital funding led by MIG Capital AG, also a founding investor of German biotech giant BioNTech. ABOUT SKYLINEDX : is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA.