Double Bond Pharmaceutical International AB (publ) ("DBP") today announces that a scientific abstract based on final clinical data from the company's extensive Real-World Evidence (RWE) study of Temodex has been submitted for review to the scientific committee of the Society for Neuro-Oncology (SNO), ahead of the annual meeting in Philadelphia, USA.

The abstract presents the final results of a retrospective cohort study encompassing a total of 375 patients who underwent surgical resection for malignant primary brain tumors. The purpose of the study was to evaluate the clinical efficacy of adding the company's local chemotherapy, Temodex, to the standardized surgical workflow.

Final Clinical Endpoints and Statistical Significance

The completed analysis of the study population demonstrates a confirmed and enhanced therapeutic benefit for patients who received Temodex as an adjunct to standard of care (SoC), compared to the control group that received SoC alone:

• Median Overall Survival (mOS) - Temodex group (n=124): 15.6 months.
• Median Overall Survival (mOS) - Control group (n=251): 10.0 months.
• Absolute Survival Benefit: 5.6 months in favor of the Temodex group.
• Hazard Ratio (HR): 0.61.
• Statistical Significance: The final results are highly significant with a p-value of 0.00062.

The finalized dataset reinforces the clinical efficacy and demonstrates a more pronounced survival difference than initially indicated by the preliminary calculations. The detailed analysis also includes subgroup stratifications based on histological and molecular markers, which have previously been submitted for presentation at the EANS2026 Congress in Hamburg.

Technical Background and Translational Relevance for SI-053

Temodex has been used clinically for over a decade in selected regions and serves as the technical prototype for DBP's global drug candidate SI-053. SI-053 is a further developed, locally acting formulation of temozolomide that has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

These final RWE data establish a verified clinical baseline for the technology ahead of upcoming prospective clinical trials in Europe.

"The submission of these final results to SNO in Philadelphia marks an important step in the company's international development strategy," says Igor Lokot, CEO of Double Bond Pharmaceutical. "SNO is the largest multidisciplinary neuro-oncology forum in the world and a central venue for presenting our latest clinical outcomes. Disseminating our data at this meeting is essential to ensure maximum international reach and impact for our research findings."

More about the Society for Neuro-Oncology (SNO): SNO is a multidisciplinary organization dedicated to promoting research and education in neuro-oncology. Its annual meeting constitutes one of the premier international forums for the presentation of new clinical and translational research findings regarding malignant CNS tumors (https://www.soc-neuro-onc.org/meetings-education/sno-conferences).

More about preliminary results of Real-World Evidence Study: https://mb.cision.com/Main/12720/4310428/3944046.pdf

More about Real-World Evidence Study: https://mb.cision.com/Main/12720/4307158/3933333.pdf

More about SI-053: SI-053, an enhanced reformulation of Temodex, is a locally acting formulation of temozolomide. SI-053 received Orphan Drug Designation from the European Medicines Agency in 2016 and received multiple Competent Authority and Ethics Committee approvals from 2021 to 2023 to initiate a Phase 1 clinical study.  In a proof-of-concept study with human subjects conducted in 2015, SI-053 demonstrated significant overall survival benefit when added to the standard of care for glioblastoma.  Video presentation: https://youtu.be/iweOQPq316o