Cytek Biosciences Stock

Cytek Biosciences, Inc. operates as a cell analysis solutions company. The company engages in advancing the next generation of cell analysis tools by leveraging novel technical approaches.

The company’s core instruments, the Aurora and Northern Lights systems, are the first full spectrum flow cytometers able to deliver high-resolution, high-content and high-sensitivity cell analysis by utilizing the full spectrum of fluorescence signatures from multiple lasers to distinguish fluorescent tags on single cells (Full Spectrum Profiling or FSP). The company’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with exquisite sensitivity.

The company’s patented FSP technology optimizes sensitivity and accuracy through its novel optical and electronic designs that utilize an innovative method of light detection and distribution. The company’s FSP platform includes instruments, reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers. As of December 31, 2022, it had sold and deployed over 1,670 instruments— primarily consisted of its Aurora and Northern Lights systems—to customers around the world, including the largest pharmaceutical companies, over 200 biopharma companies, leading academic research centers, and clinical research organizations (CROs). In 2021, the company commercially launched the Aurora cell sorter (Aurora CS), which leverages its FSP technology to further broaden its potential applications across cell analysis.

The company’s FSP platform addresses the inherent limitations of other technologies by providing a higher density of information with greater sensitivity, more flexibility and increased efficiency. The company’s patented FSP technology is designed to optimize sensitivity and accuracy through its novel optical and electronic designs that utilize an innovative method of light detection and distribution to a specifically selected number and type of detectors. This patented optics design enables researchers to effectively collect the full range of light emissions in an extremely compact space, resulting in higher resolution. The company’s platform also provides higher content by enabling development of highly complex assays with more than 40 different colors (individual fluorochromes) and thus supporting more than 40 biomarkers, all accessible within just a single tube.

The company’s solutions have enabled researchers to make significant scientific advances in key areas of medical discovery (such as oncology, immunology and infectious diseases) in addition to empowering improved downstream cell analysis with complementary cell analysis technologies (such as next-generation sequencing (NGS)).

The company’s FSP platform was purpose-built to advance the next generation of cell analysis by delivering deep insights, high-throughputs and ease-of-use.

The company’s core instruments, the Aurora and Northern Lights systems, are full spectrum flow cytometers founded on its FSP platform technology. The Aurora system—the company’s most advanced and comprehensive offering—is available with three to five lasers and is suitable for customers seeking to access more than 24 colors (with the ability to access more than 40 different colors and support more than 40 biomarkers), while the company’s Northern Lights system—its entry-level offering—is available with one to three lasers and suitable for customers seeking to access a few colors to more than 24 colors. Both instruments are upgradeable based on the desired number of lasers.

In June 2021, the company commercially launched the Aurora CS, which leverages its FSP technology to rapidly isolate living cell populations from lower-to-higher complexity panels beyond 40 biomarkers. The Aurora CS is the only cell sorter able to accommodate the same number of parameters with the same sensitivity as the Aurora cell analyzer system. Each system is supported by the company’s highly intuitive, proprietary embedded SpectroFlo software, its reagents, and its service offerings to provide a comprehensive, end-to-end platform of solutions for its customers.

Strategy

The key elements of the company’s strategy are to accelerate adoption of its FSP solutions; continue to innovate and offer its customers best-in-class FSP solutions; invest in integrated workflow solutions to drive pull-through from its consumables and services; and drive clinical research application development.

Products

The company is a leading cell analysis solutions provider that develops compact, cost-effective full spectrum profiling instruments with high multiplexing capability, and it offers a wide range of services to support scientists and clinicians. The company’s products are used in the world’s most renowned pharmaceutical and clinical research organizations, as well as premier academic and research institutions.

Aurora and Northern Lights Systems

The company’s Aurora and Northern Lights systems were commercially launched in June 2017 and October 2018, respectively. Both instruments are highly flexible, intuitive, and ultra-sensitive full spectrum flow cytometers, utilizing state-of-the-art optics and low-noise electronics to provide excellent sensitivity and resolution, allowing researchers to resolve rare cell populations that were previously challenging to resolve. The optics and electronics designs, combined with flat-top beam profiles and a unique vacuum fluidics system, translate to outstanding performance from low to high sample flow rate, analyzing up to 35,000 events per second with certain configurations. Additionally, the company’s optical design and unmixing algorithm make the instrument amenable to a wide array of applications and fluorochrome options, all without needing to reconfigure the instrument hardware as would otherwise be required on a conventional flow cytometry (CFC).

The Aurora system is available with three to five lasers and can detect more than 40 biomarkers in one sample tube. The Northern Lights system is available with one to three lasers and can detect more than 24 biomarkers in one sample tube. Both instruments are upgradeable based on the desired number of lasers, which drives greater or less access to biomarkers. In addition, both instruments incorporate the company’s SpectroFlo software, which offers an intuitive workflow from quality control to sample acquisition to data analysis, with technology- enabling tools that simplify running applications.

The company’s Aurora and Northern Lights systems are used in the study of infectious diseases, immunology, immunotherapy, immuno-oncology, oncology, inflammation, and drug discovery.

The Northern Lights CLC system was certified under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) in September 2020 and is registered as an in vitro diagnostic medical device under Northern Lights Clinical Flow Cytometer. The certification enables the Northern Lights CLC system to be sold into in vitro diagnostic laboratories in the European Union and in other countries around the world that accept this specific certification. The Northern Lights CLC system is also certified for in vitro diagnostic use as a Class II device in China.

Aurora CS System

The company’s Aurora CS was commercially launched in 2021 and is the first highly flexible, intuitive and ultra-sensitive cell sorter that leverages the detection and sensitivity capabilities of its FSP technology to isolate living cell populations from lower to higher complexity panels beyond 40 biomarkers. The company’s FSP technology enables the processing of a tremendous amount of highly complex information to provide real- time unmixing and sorting capabilities at the field-programmable gate array level. The implications are significant in terms of flexibility and user experience, including experiment workflow transportability and assay reproducibility, enabling a 40-biomarker assay to be run in both the Aurora and the Aurora CS systems, with similar results. With the company’s technology, users can first identify cell populations and then isolate the live cells for downstream studies, such as single-cell RNA sequencing, proteomics, and cell biology. This new technology will enable users to gain a deeper level of cell classification, take advantage of key trends and scientific expansion, and allow for greater clinical research applications, such as with minimal residual disease (MRD), cell analysis and disease discovery.

Unlike other high-capacity sorters, the Aurora CS is the only cell sorter that can accommodate the same number of parameters with the same sensitivity as the Aurora system and isolate living cell populations of interest using the same panel and without having to alter the optical configuration, while also being able to sort panels designed for conventional analyzers.

Reagents and Kits

The company also has launched its reagent products to provide additional options for researchers and clinical laboratories when choosing which biomarkers to run together in a panel, particularly since its Aurora, Northern Lights and Aurora CS systems allow for more fluorochromes to be run together than was previously commercially available. The company’s technology was able to inform its fluorochrome development through the identification of areas within the spectrum for which there were no available fluorochrome options. The company’s cFluor reagents are fluorochrome conjugated antibodies used to identify cells of interest for analysis on its instruments. The company offers and continues to develop cFluor immunoprofiling kits, which include the cFluor reagents and tools necessary to simplify the workflow from sample preparation to data analysis.

The company launched its 14-color immunoprofiling kit in December 2020, which is designed to distinguish different subsets of T, B and natural killer (TBNK) cells, and its 25-color immunoprofiling assay in October 2021 to provide a turnkey solution for identifying major human immune subpopulations for TBNK cells, monocytes, dendritic cells, and basophils – all of which play important roles in the innate and adaptive immune response in various diseases. The company released a 13-color human B cell monitoring kit in December 2022 to provide a turnkey solution for identifying and enumerating B cell subsets in human whole blood and peripheral blood mononuclear cells, and in January 2023, it introduced the single-tube 20-color panel for identifying and characterizing normal and aberrant cells and evaluating MRD in acute myeloid leukemia samples. Most recently, in February 2022, the company released its pan leukocyte kit, a lyse-no-wash assay designed to help researchers fully enumerate the complete set of major leukocyte subsets in drug discovery and development. These research use only (RUO) products are optimized for use with its Aurora and Northern Lights systems and designed to simplify the workflow and improve operational efficiency for its customers.

The company’s single-color reagents are registered as Class 1 with the China National Medical Products Administration (NMPA) and in the European Union under the IVDD. The company is seeking Class 3 registration with the NMPA of its 6-color reagent cocktails that identify and determine the percentages and absolute counts of TBNK cells in peripheral blood. The company expects these recent and planned reagent and application solutions to be a significant driver of its future reagent revenue and pull-through as its installed base of instruments grows.

Automated Micro-Sampling System and Automated Sample Loader System

The Automated Micro-Sampling (AMS) and Automated Sample Loader (ASL) systems are automated loaders designed to integrate seamlessly into the Aurora and Northern Lights systems, increasing sample throughput and adding automation capabilities to the company’s FSP systems. The systems offer preset settings for ease of use, but also allow researchers to customize and fine-tune the systems for their unique experimental requirements. Their reliable 96-well plate acquisition solution increases productivity. The ASL adds additional compatibility with 96 deep-well plates 40-tube racks. Both systems have three throughput modes (high-throughput, default, low carryover) to meet changing customer priorities.

SpectroFlo Software

The company’s proprietary SpectroFlo software is integrated into its systems and is unique in that it offers intuitive workflows for handling full spectrum flow cytometry data, from quality control to data analysis. The software was developed specifically for the company’s Aurora and Northern Lights systems to streamline instrument setup, automated quality control, data analysis and experiment exports. With the ability to import a previously designed experiment template, users are able to quickly set up their experiments and there is no need to re-enter the panel design, acquisition criteria, reagent information or data analysis worksheets. With the company’s SpectroFlo software, users can conveniently and efficiently collect both raw and unmixed FCS 3.1 files, which can be used to live unmix samples and extract autofluorescence that would otherwise negative impact data resolution.

Customer Support Tools

The company strives to continually innovate by developing new quantitative tools, which are integrated into its software or available to its customers on its website, to enable users to independently create high- color panels for use with its systems, to support efficient workflow solutions and to provide an intuitive user experience. As fluorochrome (color) selection is a key component of assay development and optimization, the company’s full spectrum viewer is a unique tool capable of displaying the full emission spectrum of a fluorochrome (emission at different wavelengths post-excitation with multiple lasers).

The company’s FSP technology provides an in-depth understanding of the fluorescence emission characteristics of nearly every color available in the market and its full spectrum viewer provides users with comprehensive information regarding emission characteristics of the fluorochromes to optimize fluorochrome selection for assay development. As a complementary tool to the company’s full spectrum viewer, it has developed the Similarity and the Complexity indices, which provide unique metrics for assessing fluorochrome compatibility within a panel. The Similarity index compares the emission spectrum of two dyes, identifying whether the dyes have unique characteristics or if the dyes are identical, which determines whether they can be used together to analyze a sample in a flow cytometry assay. The Complexity index is a metric that predicts how well a panel of colors will work in combination to minimize loss of resolution and sensitivity.

Additionally, the company recently launched Cytek Cloud, a digital ecosystem that supports full spectrum flow cytometry research from panel design to data acquisition, seamlessly integrating with the company’s SpectroFlo software.

DxP Athena

The company’s DxP Athena conventional flow cytometry system is available for sale only in China. It is certified for clinical use by China NMPA. The DxP Athena system incorporates DxP technology with efficient PMTs to enable high sensitivity and high resolution and the company’s proprietary QbSure software to ensure optimal daily instrument performance. The system is available in multiple configurations with one to three lasers and up to 13 fluorescence detection channels. The automated monthly clean bleach cycle minimizes downtime, streamlines maintenance and encourages compliance.

Sales and Marketing

The company distributes its products through its direct sales force and support organizations located in North America, Europe, China and several countries in the Asia-Pacific region, and through distributors or sales agents in several countries in Europe, Latin America, the Middle East and the Asia-Pacific region. The company’s sales and marketing efforts are targeted at academic and governmental institutions, clinical research organizations (CROs), pharmaceutical and biotechnology companies and clinical laboratories focused on single-cell analysis.

Competition

The company’s direct competitors include Agilent Technologies, Beckman Coulter (Danaher Corporation); Becton, Dickinson and Company; Bio-Rad Laboratories; Standard BioTools Inc; Miltenyi Biotec; Sony Biotechnology (Sony Corporation); and Thermo Fisher Scientific.

Intellectual Property

As of December 31, 2022, the company owned 12 issued U.S. utility patents, two issued Japan utility patents, one issued European utility patent and one issued China utility patent. The company had 42 pending utility patent applications, including 25 utility patent applications in the United States, five utility patent applications in the European Union, five utility patent applications in China and three utility patent applications in Japan. Assuming all maintenance fees are paid, the U.S. issued patents are expected to naturally expire between years 2023 and 2038. Patents covering intellectual property relating to design specific technologies invented by the company’s researchers in Shanghai and Wuxi, China are filed in China and owned by its China subsidiaries, respectively. As of December 31, 2022, the company’s Shanghai subsidiary owned 15 issued utility patents and one issued invention patent and has ten pending invention patent applications and one pending utility patent application, and its Wuxi subsidiary owned 36 issued patents and had eight pending patent applications, including nine pending utility patent applications and seven pending invention patent applications.

Key Agreements, Licenses and Collaborations

In 2020, the company entered into a Supply and License Agreement with Biotium, Inc. (Biotium) pursuant to which Biotium agreed to supply, and it obtained a worldwide, non-exclusive license to market and resell to its customers and distributors, certain Biotium products to conjugate proteins and/or antibodies and to use such conjugates as a component in its cFluor reagent products, for research and analyte specific reagents (as defined by 21 CFR 864.4020) use only (the Field of Use) (the Biotium Agreement).

In 2021, the company and Cytek (Wuxi) Biosciences Co., Ltd, its Wuxi, China subsidiary, entered into a Supply Agreement (the Coherent Agreement) with Coherent NA, Inc. (Coherent) pursuant to which Coherent agreed to sell and supply to it, on a non-exclusive basis, laser products manufactured by Coherent. The company provides Coherent with rolling forecasts of its anticipated orders, which are non-binding.

Research and Development

The company’s research and development expenses were $34.9 million for the year ended December 31, 2022.

History

Cytek Biosciences, Inc. was founded in 1992. The company was incorporated in the state of Delaware in 2014.