SDS Optic S.A. updates its strategy and pauses the second part of the inPROBE clinical trial

After a thorough analysis of the results from the first part of the clinical study, SDS Optic S.A. confirms the rationale for further development of inPROBE technology in diagnostics. The study results have shown that this technology is capable of detecting both high and low expression of the HER2 biomarker, which is of significant clinical importance in the context of new targeted therapies.

The Company's Management Board also identifies potential applications of inPROBE technology in oncology diagnostics for at least ten other types of cancer, including gastric cancer and NSCLC (non-small cell lung cancer). This technology may be used in minimally invasive robotic procedures, enabling precise molecular profiling of tumors.

Refining the regulatory pathway and collaboration with the FDA

Collaboration with the European Investment Bank and renowned CRO companies has enabled the Company to better understand the current regulatory requirements for the inPROBE technology. As a result, a decision was made to pause the second part of the clinical trial until full clarity is obtained regarding the registration pathway in the US and the EU.

As part of its regulatory strategy, SDS Optic plans to conduct a Pre-submission review process with the U.S. Food and Drug Administration (FDA), which will help better align the technology with market requirements in the US. At the same time, certification options in the European Union are being analyzed.

According to the Company's CEO Marcin Staniszewski, the decisions made and potential changes may have a positive impact on the further development of the company, "SDS Optic is at a moment where every decision can influence not only the timing of the project’s implementation but also the success of the entire venture. We are implementing a plan to introduce a revolutionary fiber optic molecular diagnostic method to the market amidst extremely dynamic changes in diagnostic practices and cancer treatment. No one has proposed such a solution so far, which is why new opportunities are constantly opening up for our team, but also potential problems and risks, which we are continuously identifying and carefully examining. Our goal is to choose the optimal path for the final success of the technology. Therefore, after many analyses and consultations, I have made the decision to delay the start of the second phase of clinical trials and begin the process of updating the Company's strategy. I believe this will lead to the full utilization of the potential of our technology."

New sources of income and development of competencies.

SDS Optic S.A. plans to expand its business model to include three new areas: 1. Production of monoclonal antibodies – development of a cell culture laboratory and production of pilot batches of antibodies for scientific and diagnostic research. 2.Commercial applications of inPROBE – use of a microprobe to assess drug concentration in selected areas of the body in preclinical studies. 3. thin-film technologies – implementation of new optoelectronic methods to improve the quality and durability of optical devices.

Market strategy and cooperation with Clairfield International

The company is intensifying its efforts in the area of market strategy and cooperation with potential business partners. To this end, together with Clairfield International, regular meetings are held with the goal of developing a new partnership strategy and further market development. A new series of meetings with potential partners is also planned for this purpose.

Double fixing and the future on the stock exchange

SDS Optic S.A. is also working on returning to the continuous trading system on NewConnect and is optimizing its cost strategy to increase the attractiveness of the Company for investors. The Company will provide ongoing updates on key decisions in this regard.

Summary

The update of the SDS Optic S.A. strategy opens new opportunities for development and strengthens the Company's position in the field of modern oncological diagnostics. Further actions will be focused on optimizing the regulatory pathway, developing commercial applications of the inPROBE technology, and diversifying revenue sources.

The company has announced that it will organize an investor webinar in the near future, during which the Management Board will present new materials to its investors, taking into account the potential of the decisions made and possible changes. The Management Board will also provide updated information regarding the milestones being achieved and future plans. After the presentation, the company also plans a Q&A session, which will allow addressing potential questions from shareholders. Details regarding the SDS Optic webinar will be published soon.