Summary of 2021 at SDS Optic Inc. and the announcement of the next milestones in 2022 Posted on 1 June 202210 August 2022 by Karol Maryniowski SDS Optic Inc., a company developing the proprietary inPROBE technology platform for real-time medical diagnosis of cancer, infectious, viral, bacterial and fungal diseases, has published its annual report for 2021. The past months have been accompanied by many milestone events for the development of the company and its product. Summary of 2021 at SDS Optic Inc. In 2021, the Company carried out toxicological tests on animals, registered a patent for its technology, and successfully acquired PLN 11 million in the pre-IPO offer and began the process of entering the NewConnect market. The debut of the Company took place in March this year. At the same time, SDS Optic has been intensively preparing for the start of clinical trials of its HER2 positive breast cancer device and has completed the first milestone on the way to launching its own pilot production of inPROBE fibre optic biosensors. – In 2021, we implemented many milestones that were of importance for the further development of our Company and we are very satisfied with the pace we have achieved. In order to point out the most important events for us, it is necessary to mention the commencement of preparations for clinical trials despite the ongoing COVID-19 pandemic, including the selection of the first two clinical centres that will participate in the first stage of the research. The last round of financing marked a very important event for the Company, as we were able to attract renowned investors, and this was followed by the beginning of preparations for the debut on the NewConnect market. Finally, I would like to mention the conduct and positive completion of toxicological tests of inPROBE microprobe in a certified animal testing centre – says Marcin Staniszewski, Chief Executive Officer, Chief Technology Officer of SDS Optic Inc. – Download the 2021 annual report of SDS Optic Inc. – Further inPROBE applications Last year SDS Optic also worked on new applications of inPROBE technology. Our subsidiary FiBioMed LTD acquired PLN 10 million from the National Centre for Research and Development for the purposes of R&D in the field of diagnostics of infectious, viral, bacterial and fungal diseases. One of the first new research areas will be the diagnosis of the SARS-CoV-2 virus. Adaptation of biosensor will allow for simultaneous analysis of 96 samples (a panel of optical fibre microprobes), which in turn will allow the creation of a mobile, high-pass diagnostic device opening the possibility of safe testing of samples in real time and in large clusters of people, including in large cities, office buildings, workplaces or schools. There will also be the option of adapting the device to the analysis of other pathogens and diagnostic markers, including in the field of sepsis markers. – The FiBioMed team actively works on new fields of application for our inPROBE biosensor. Till now we managed to adjust the design of the probe in technological dimension, manufacture its crucial components, and also the biological components that are indispensable in the diagnostic process. We have the first prototypes of sensors ready. We designed and built a 3D model of the analyzer head for simultaneous handling of samples of 96 patients. We are currently working on the control software, we want the entire diagnostic process to be as automated as possible – says the President of the Company. Promotion of the Company on the international scene The company was also very active in the field of promotion of its technology, participating in several major industry events such as MEDICA2021 in Dusseldorf, Life Science Open Space 2021 or the European Innovation Council Summit 21. Participation in such events allows us not only to present the product and technology to the broader market, but above all, it supports building business relations and reaching potential end customers. The potential of inPROBE technology was also noticed in Poland, where SDS Optic was included in the publication summarizing 115 of the most innovative medical entities: Top Disruptors in Healthcare 2021. It is worth noting that the partners of the report were: Google for Startups, AstraZeneca, EIT Health and PZU Zdrowie. Financial results SDS Optic is at the stage of confirming the effectiveness of the developed biosensor for the diagnosis of HER2-positive breast cancer, which is reflected by its 2021 financial results. Throughout 2021, The Company achieved over PLN 451 thousand in sales revenue. Other operating revenues of the Company amounted to PLN 2.66 million (compared to PLN 3.36 million in 2020) and were based mainly on subsidies acquired by the Company in previous periods. The operating costs amounted to PLN 3.97 million (PLN 3.49 million in 2020) and resulted mainly from the research and development works carried out. At the end of 2021 The Company had over PLN 8.3 million in cash, which contributed to maintaining financial stability and was related to the issues of series C and D shares carried out in the first half of the year, from which a total of PLN 11.3 million was raised. Importantly, the Company does not have any outstanding loans and credits, or debt in the form of bonds. The total fixed assets of SDS Optic at the end of 2022 amounted to about PLN 1.2 million, compared to PLN 206 thousand in the previous year. – Our model of financial activity at the current stage of the Company’s development was largely based on grants and funds acquired from capital investors. We raise funds for a specific stage of work or project and we reliably carry them out. Our vision has convinced many private and institutional investors so far, some of whom have invested in the development of SDS Optic at the earliest stages of our journey, which is already in 2013. It should be emphasized that our business model has been very well thought out and we are well prepared to achieve the subsequent milestones. We have a very responsible cost policy, which allows us to maintain financial stability, we do not have any long-term liabilities and we receive further tranches of grant financing on an ongoing basis, which proves our ability to obtain further demanded funds. One of the objectives for the coming quarters is to build the value of the Company’s assets, including fixed assets, and to carry out further stages of R&D work. Our overarching goal is to commercialize the first use of inPROBE, which will allow the Company to generate the first significant amounts of revenue in the coming years – says Mateusz Sagan, Chief Business Officer, SVP at SDS Optic Inc. On the eve of inPROBE clinical trials Since the beginning of 2022, the SDS Optic team has been intensively preparing for the commencement of Phase I clinical trials of the inPROBE microprobe. In the first quarter, training was conducted in carefully selected and contracted clinical centres for physicians and medical staff, who will participate in the research. This gave them the opportunity to submit their proposals for testing procedures. The company openly accepted these reports and, in consultation with a professional CRO advisor, who coordinates the research process, decided to update the necessary documentation at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Organizational procedures were also been developed and tested to assist in the smooth implementation of the research. – We will be the first in the world to detect and measure the concentration of the HER2 tumour biomarker in the tumour area without simultaneously acquiring the affected tissue from the tumour (biopsy). In clinical trials, we expect confirmation of information obtained in animal models, and the acquired knowledge will be of great importance for the further development of our inPROBE technology and the possibility of its accurate calibration against traditional methods of histopathological diagnosis – the IHC or FISH methods. We currently await the update of the consent to conduct the trial that we first received at the end of 2021. We decided to introduce and report changes to the research procedure to make it even more reliable and provide the greatest possible value in the process of development of the entire technology. We also have the final report in mind, which will be created after the end of this and the subsequent phase of research and which will be important evidence for the introduction of our solution to the wider market. We are also thinking about the process of its commercialization, we are already taking care that the commercial, clinical and regulatory values of our technological documentation are as high as possible – explains Magdalena Staniszewska PhD, DSc – co-author of the technology and Chief Science Officer of SDS Optic Inc. The budget for both phases of the clinical trial was secured by the Company from the funds obtained under the SME Instrument Horizon2020 program. The value of the current financial expenditures related to the development of inPROBE technology amounted to approx. PLN 43 million, of which approx. PLN 7 million will be allocated to clinical trials on patients. These funds were acquired, among others, from the SME Instrument Horizon2020 programme run by the European Commission, the National Centre for Research and Development and from our capital investors. SDS Optic Inc. has developed an innovative and globally unique inPROBE fibre optic micro-probe. It is a biosensor with a high level of sensitivity and specificity, allowing for biological measurement of the concentration of a specific biomarker or a dedicated compound in the patient’s body (in vivo test), eliminating the need to collect tissue (perform biopsy). The basic field of application, the development and commercialization of which the Company is currently focusing on, is diagnostics, as well as targeted treatment of HER2-positive breast cancer markers. SDS Optic technology could be an alternative or complementary diagnostic method for the more time-consuming and invasive traditional biopsy. Market reports indicate that the average annual growth rate of the global market for HER2 molecular diagnostics in 2019-2025 will be 12%, increasing the value of this market to over USD 6.4 billion in 2025. In 2019, more than 7.5 million tests were performed in the area of HER2 molecular diagnostics of a total value of more than USD 4.1 billion. Announcement of the implementation of the subsequent milestones of SDS Optic Inc. The second half and the end of 2022 will keep our Company equally busy. SDS Optic is completing preparations for clinical trials divided into phase I (safety) and phase II (validation), and at the end of the year it intends to launch the upcoming pilot production line of its biosensors. At the same time, the Company initiated its search for a specialized advisor in the future process of commercializing the biosensor for diagnosis in HER2-positive breast cancer and is preparing to launch its branch together with a research and development centre in the United States. Stay tuned!